This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01972841

Acronym

SYNERGY

Enrollment

3527

Registered

2013-10-31

Start date

2013-11-05

Completion date

2015-10-22

Last updated

2024-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urgency Incontinence, Urinary Bladder Diseases\Urologic Diseases, Urinary Bladder Overactive

Keywords

Combination Therapy, Mirabegron, Overactive Bladder, Urgency, Urinary Incontinence, Nocturia, Solifenacin Succinate

Brief summary

The purpose of this study was to examine how well two medicines (solifenacin succinate and mirabegron) combined work compared to each medicine alone in the treatment of bladder problems.

Interventions

DRUGSolifenacin succinate

Oral tablet

DRUGMirabegron

Oral tablet

DRUGPlacebo to match solifenacin succinate

Oral tablet

DRUGPlacebo to match mirabegron

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject was willing and able to complete the micturition diary and questionnaires correctly and able to measure his/her vital signs at home at stipulated time points, using the device provided by the study personnel, and to adequately record the readings; * Subject had symptoms of wet OAB (urinary frequency and urgency with incontinence) for at least 3 months;

Exclusion criteria

* Subject had significant PVR volume (\> 150 mL); * Subject had a neurological cause for detrusor overactivity (e.g. neurogenic bladder, diabetic neuropathy with autonomic component or bladder involvement, or systemic or central neurological disease such as multiple sclerosis and Parkinson's disease with autonomic component or bladder involvement). An autonomic component could be inferred when autonomic functions were affected, including heart rate, blood pressure, perspiration and digestion. * Subject had an indwelling catheter or practices intermittent self catheterization. * Subject had chronic inflammation such as bladder pain syndrome /interstitial cystitis, symptomatic bladder stones or any previous or current radiation cystitis. * Subject had received intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin. * Subject had moderate to severe hepatic impairment * Subject had severe renal impairment * Subject had a clinically significant abnormal ECG * Subject had a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening. * Subject had an average QTcF interval \> 450 ms for males or \> 470 ms for females based on the triplicate ECGs completed at Screening or is at risk of QT prolongation (e.g., family history of long QT syndrome, hypokalaemia). * Subject had severe hypertension, which is defined as a sitting average systolic blood pressure ≥ 180 mmHg and/or average diastolic blood pressure ≥ 110 mmHg.

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and EoT (up to 12 weeks)	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	Baseline and EoT (up to 12 weeks)	A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Secondary

Measure	Time frame	Description
Change From Baseline to EoT in Mean Volume Voided Per Micturition	Baseline and EoT (up to 12 weeks)	The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	Baseline and EoT (up to 12 weeks)	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	Baseline and EoT (up to 12 weeks)	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	—
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and weeks 4, 8 and 12	—
Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Baseline and weeks 4, 8 and 12	—
Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Baseline and weeks 4, 8 and 12	—
Change From Baseline to EoT in Corrected Micturition Frequency	Baseline and Week 12	Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.
Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	—
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)	—
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Pads Used at Weeks 4, 8, 12 and EoT	Weeks 4, 8 and 12 (up to 12 weeks)	The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.
Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)	—
Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Baseline and weeks 4, 8 and 12 (up to 12 weeks)	The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.
Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.
Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)	The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.
Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Baseline and weeks 4, 8 and 12	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12 and EoT (up to 12 weeks)	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12 and EoT (up to 12 weeks)	The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).
Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Baseline and EoT (up to 12 weeks)	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Baseline and EoT (up to 12 weeks)	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Baseline and EoT (up to 12 weeks)	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Baseline and EoT (up to 12 weeks)	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Baseline and EoT (up to 12 weeks)	The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Baseline and week 12 and EoT (up to 12 weeks)	The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Baseline and week 12 and EoT (up to 12 weeks)	—
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Baseline and week 12 and EoT (up to 12 weeks)	—
Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Baseline and week 12 and EoT (up to 12 weeks)	—
Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Baseline and week 4, 8 and 12	The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).
Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Weeks 4, 8 , 12 and EoT (up to 12 weeks)	The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)	A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.
Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)	PVR volume was assessed by ultrasonography or a bladder scanner.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.
Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax (time to maximum concentration) window of mirabegron and solifenacin was from 4-6 hours postdose.
Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Weeks 4, 8,12 and EoT (up to 12 weeks)	The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.
Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.
Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.
Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Baseline and weeks 4, 12 and EoT (up to 12 weeks)	Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose.
Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Weeks 4, 8, 12 and EoT (up to 12 weeks)	The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.

Countries

Argentina, Australia, Belgium, Bulgaria, Canada, China, Colombia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States

Participant flow

Recruitment details

Patients who had symptoms of wet overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled at 435 centers in 42 countries. Eligible participants went into a single-blind, 4-week placebo run-in period and completed a micturition diary the last 7 days prior to each study visit.

Pre-assignment details

A total of 6991 participants were screened, 6275 participants received placebo run-in treatment and 3527 participants were randomized into 1 of 6 treatment arms in a 1:1:1:1:2:2 ratio in the 12-week double-blind treatment period. A total of 953 participants were also enrolled in an ambulatory blood pressure monitoring (ABPM) substudy.

Participants by arm

Arm	Count
Placebo Participants who received matching placebo once a day for 12 weeks.	447
Mirabegron 25 mg Participants who received mirabegron 25 mg once a day for 12 weeks.	441
Mirabegron 50 mg Participants who received mirabegron 50 mg once a day for 12 weeks.	437
Solifenacin 5 mg Participants who received solifenacin 5 mg once a day for 12 weeks.	434
Solifenacin 5 mg + Mirabegron 25 mg Participants who received solifenacin 5 mg and mirabegron 25 mg once a day for 12 weeks.	885
Solifenacin 5 mg + Mirabegron 50 mg Participants who received solifenacin 5 mg and mirabegron 50 mg once a day for 12 weeks.	883
Total	3,527

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003	FG004	FG005
Overall Study	Adverse Event	13	8	12	9	21	26
Overall Study	Did not have end of treatment page	0	0	0	0	1	0
Overall Study	Lack of Efficacy	1	0	0	2	4	1
Overall Study	Lost to Follow-up	4	2	4	2	9	3
Overall Study	Miscellaneous	0	0	4	1	0	4
Overall Study	Protocol Violation	2	2	3	5	9	4
Overall Study	Randomized but Never Received Treatment	2	5	4	2	6	13
Overall Study	Withdrawal by participants	21	27	23	16	33	34

Baseline characteristics

Characteristic	Placebo	Mirabegron 25 mg	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 25 mg	Solifenacin 5 mg + Mirabegron 50 mg	Total
Age, Continuous	57.46 Year STANDARD_DEVIATION 13.2	56.77 Year STANDARD_DEVIATION 13.46	56.69 Year STANDARD_DEVIATION 13.28	57.88 Year STANDARD_DEVIATION 12.92	56.94 Year STANDARD_DEVIATION 13.78	57.3 Year STANDARD_DEVIATION 13.46	57.16 Year STANDARD_DEVIATION 13.42
Mean number of incontinence episodes/24 h	3.41 incontinence episodes STANDARD_DEVIATION 3.37	3.42 incontinence episodes STANDARD_DEVIATION 3.4	3.18 incontinence episodes STANDARD_DEVIATION 3.47	3.58 incontinence episodes STANDARD_DEVIATION 3.51	3.22 incontinence episodes STANDARD_DEVIATION 3.17	3.16 incontinence episodes STANDARD_DEVIATION 3.08	3.29 incontinence episodes STANDARD_DEVIATION 3.29
Mean number of micturitions/24 h	10.97 micturitions STANDARD_DEVIATION 2.86	10.81 micturitions STANDARD_DEVIATION 2.63	11.19 micturitions STANDARD_DEVIATION 3.27	10.76 micturitions STANDARD_DEVIATION 2.47	10.73 micturitions STANDARD_DEVIATION 2.88	10.74 micturitions STANDARD_DEVIATION 2.36	10.84 micturitions STANDARD_DEVIATION 2.73
Mean number of nocturia episodes/24 h	1.57 nocturia episodes STANDARD_DEVIATION 1.06	1.53 nocturia episodes STANDARD_DEVIATION 1.02	1.59 nocturia episodes STANDARD_DEVIATION 1.09	1.59 nocturia episodes STANDARD_DEVIATION 0.96	1.56 nocturia episodes STANDARD_DEVIATION 1.07	1.52 nocturia episodes STANDARD_DEVIATION 0.97	1.56 nocturia episodes STANDARD_DEVIATION 1.03
Mean number of pads used/24 h	2.87 pads STANDARD_DEVIATION 2.99	2.86 pads STANDARD_DEVIATION 2.7	2.62 pads STANDARD_DEVIATION 3.18	2.87 pads STANDARD_DEVIATION 3.14	2.50 pads STANDARD_DEVIATION 2.58	2.58 pads STANDARD_DEVIATION 2.39	2.67 pads STANDARD_DEVIATION 2.76
Mean number of urgency episodes (Grade 3 or 4)/24 h	6.52 urgency episodes STANDARD_DEVIATION 4.05	6.22 urgency episodes STANDARD_DEVIATION 3.89	6.46 urgency episodes STANDARD_DEVIATION 4.88	6.48 urgency episodes STANDARD_DEVIATION 3.88	6.22 urgency episodes STANDARD_DEVIATION 3.7	6.22 urgency episodes STANDARD_DEVIATION 3.56	6.32 urgency episodes STANDARD_DEVIATION 3.92
Mean number of urgency incontinence episodes/24 h	3.14 urgency incontinence episodes STANDARD_DEVIATION 3.23	3.00 urgency incontinence episodes STANDARD_DEVIATION 3.09	2.89 urgency incontinence episodes STANDARD_DEVIATION 3.31	3.23 urgency incontinence episodes STANDARD_DEVIATION 3.34	2.85 urgency incontinence episodes STANDARD_DEVIATION 2.81	2.80 urgency incontinence episodes STANDARD_DEVIATION 2.64	2.94 urgency incontinence episodes STANDARD_DEVIATION 3
Mean volume voided per micturition	157.94 mL STANDARD_DEVIATION 58.78	152.46 mL STANDARD_DEVIATION 60.96	155.31 mL STANDARD_DEVIATION 60.78	151.94 mL STANDARD_DEVIATION 59.29	159.32 mL STANDARD_DEVIATION 58.29	153.57 mL STANDARD_DEVIATION 59.67	155.43 mL STANDARD_DEVIATION 59.49
Number of incontinence episodes/week	23.6 incontinence episodes STANDARD_DEVIATION 23.6	23.5 incontinence episodes STANDARD_DEVIATION 23.6	21.7 incontinence episodes STANDARD_DEVIATION 23.8	24.8 incontinence episodes STANDARD_DEVIATION 24.5	22.1 incontinence episodes STANDARD_DEVIATION 21.7	21.7 incontinence episodes STANDARD_DEVIATION 21.3	22.7 incontinence episodes STANDARD_DEVIATION 22.7
Number of nocturia episodes/week	10.9 nocturia episode STANDARD_DEVIATION 7.4	10.6 nocturia episode STANDARD_DEVIATION 7.1	11.0 nocturia episode STANDARD_DEVIATION 7.6	11.0 nocturia episode STANDARD_DEVIATION 6.6	10.8 nocturia episode STANDARD_DEVIATION 7.4	10.5 nocturia episode STANDARD_DEVIATION 6.7	10.8 nocturia episode STANDARD_DEVIATION 7.2
Number of pads used/week	19.8 pads STANDARD_DEVIATION 20.9	19.6 pads STANDARD_DEVIATION 18.7	17.9 pads STANDARD_DEVIATION 21.7	19.9 pads STANDARD_DEVIATION 21.8	17.1 pads STANDARD_DEVIATION 17.7	17.7 pads STANDARD_DEVIATION 16.4	19.3 pads STANDARD_DEVIATION 19
Number of urgency incontinence episodes/week	21.7 urgency incontinence episodes STANDARD_DEVIATION 22.6	20.6 urgency incontinence episodes STANDARD_DEVIATION 21.4	19.8 urgency incontinence episodes STANDARD_DEVIATION 22.7	22.4 urgency incontinence episodes STANDARD_DEVIATION 23.3	19.5 urgency incontinence episodes STANDARD_DEVIATION 19.3	19.2 urgency incontinence episodes STANDARD_DEVIATION 18.2	20.3 urgency incontinence episodes STANDARD_DEVIATION 20.7
Sex: Female, Male Female	345 Participants	343 Participants	338 Participants	342 Participants	686 Participants	684 Participants	2738 Participants
Sex: Female, Male Male	102 Participants	98 Participants	99 Participants	92 Participants	199 Participants	199 Participants	789 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk
deaths Total, all-cause mortality	0 / 429	0 / 423	0 / 422	0 / 423	0 / 853	0 / 848
other Total, other adverse events	8 / 429	17 / 423	14 / 422	25 / 423	72 / 853	60 / 848
serious Total, serious adverse events	8 / 429	6 / 423	5 / 422	3 / 423	12 / 853	19 / 848

Outcome results

Primary

Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS comprised all RAS patients who took ≥ 1 dose of double-blind treatment after randomization, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from one site. Last observation carried forward (LOCF) was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.34 incontinence episodes	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.70 incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.76 incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.79 incontinence episodes	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-2.04 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.98 incontinence episodes	Standard Error 0.07

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.07295% CI: [-0.49, -0.01]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.03395% CI: [-0.44, 0.04]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [-0.58, -0.1]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.05295% CI: [-0.47, 0.01]Stratified rank ANCOVA

Primary

Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

A micturition was defined as any voluntary micturition (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period.

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS. LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-1.64 micturitions	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.00 micturitions	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.03 micturitions	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.20 micturitions	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.49 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.59 micturitions	Standard Error 0.08

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00695% CI: [-0.67, -0.11]ANCOVA

Secondary

Change From Baseline to EoT in Corrected Micturition Frequency

Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline.

Time frame: Baseline and Week 12

Population: FAS. LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to EoT in Corrected Micturition Frequency	0.15 micturitions	Standard Error 0.24
Mirabegron 25 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-0.17 micturitions	Standard Error 0.24
Mirabegron 50 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-0.97 micturitions	Standard Error 0.24
Solifenacin 5 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-1.28 micturitions	Standard Error 0.24
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-1.10 micturitions	Standard Error 0.17
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-1.52 micturitions	Standard Error 0.17

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.5295% CI: [-0.39, 0.76]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.41395% CI: [-0.82, 0.34]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00295% CI: [-1.5, -0.34]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.0695% CI: [-1.13, 0.02]ANCOVA

Secondary

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

The EQ-5D questionnaire was an international, standardized, nondisease specific instrument for describing and valuing health status, and has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension had 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	42 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	5 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	7 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	7 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	49 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	17 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	9 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	10 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	17 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	19 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	12 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	42 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	157 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	60 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	27 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	40 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	16 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	8 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	13 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	6 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	17 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	176 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	12 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	19 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	11 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	5 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	187 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	12 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	4 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	25 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	45 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	54 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	166 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	29 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	59 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	40 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	17 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	5 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	22 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	14 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	10 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	5 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	5 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	43 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	18 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	45 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	13 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	42 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	79 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	122 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	360 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	18 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	5 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	8 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	5 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	11 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	12 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	13 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	11 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	23 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	41 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	50 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	35 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	4 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	5 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	16 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anx	65 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	14 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	134 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	370 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	6 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	6 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	3 participants

Secondary

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	53 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	8 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	10 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	54 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	12 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	11 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	31 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	23 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	20 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	38 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	131 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	51 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	29 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	49 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	11 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	14 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	9 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	15 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	13 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	175 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	4 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	24 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	20 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	17 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	16 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	153 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	14 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	37 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	45 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	44 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	154 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	33 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	13 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	46 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	47 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	18 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	23 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	22 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	15 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	4 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	11 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	4 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	46 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	15 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	74 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	14 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	45 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	94 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	117 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	290 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	34 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	7 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	15 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	4 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	11 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	8 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	19 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	20 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	6 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	40 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	45 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	51 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discom.	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	46 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	4 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> exteme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	19 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	101 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	14 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	105 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	317 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	11 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	12 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 participants

Secondary

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	13 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	10 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	17 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	311 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	21 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	9 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	9 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	6 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	10 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	324 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	17 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	8 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	13 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	8 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	8 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	8 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	336 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	12 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	16 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	9 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	25 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	20 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	319 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	12 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	5 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	17 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	20 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	9 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	8 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	12 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	22 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	7 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	652 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	35 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	22 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> moderate problems	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> unable to w/d	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> moderate problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> slight problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> slight problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> slight problems	26 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> slight problems	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no data	12 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no problems	4 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no problems	18 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> no data	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> no problems	33 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> moderate problems	4 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> slight problems	26 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> unable to wash/dress myself	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> slight problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> moderate problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> no problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Moderate problems -> moderate problems	9 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> moderate problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Severe problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No problems -> no problems	647 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	No data -> no problems	18 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Unable to wash/dress myself -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care	Slight problems -> severe problems	2 participants

Secondary

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	45 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	6 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	7 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	9 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	28 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	15 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	12 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	4 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	3 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	15 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	1 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	12 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	2 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	14 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	37 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	196 participants
Placebo	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	41 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	25 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	29 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	9 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	2 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	13 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	9 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	11 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	228 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	4 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	15 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	16 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	9 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	5 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	9 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	219 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	6 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	28 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	23 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	7 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	52 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	223 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	25 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	52 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	25 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	13 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	14 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	12 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	3 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	7 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	29 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	18 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	37 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	18 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	44 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	64 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	98 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	5 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	434 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	25 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	9 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	3 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	8 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	7 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	13 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems ->unable to do usual activities	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	11 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> slight problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	17 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	30 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	48 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	26 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	4 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems ->unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do usu.	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	12 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	56 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	15 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	95 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	451 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	3 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> unable to do usual activities	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	9 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	7 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	11 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	1 participants

Secondary

Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	33 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	5 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	3 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	11 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	27 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	2 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	11 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	10 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	5 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	12 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	8 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	6 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	21 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	1 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	18 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	2 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	17 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	16 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	204 participants
Placebo	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	4 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	35 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	20 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	20 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	6 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	3 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	7 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	12 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	10 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	12 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	239 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	5 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	1 participants
Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	5 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	25 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	2 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	10 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	9 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	8 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	10 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	225 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	4 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	3 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	4 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	25 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	24 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	9 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	1 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 participants
Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	35 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	227 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	22 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	4 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	30 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	19 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	18 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	22 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	13 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	7 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	4 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	8 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	1 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	6 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	2 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Solifenacin 5 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	24 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	19 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	41 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	15 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	31 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	40 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	76 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	4 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	6 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	449 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	33 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	11 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	15 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	8 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	13 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	12 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	1 participants
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	20 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	10 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	10 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	35 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	25 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	38 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	46 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	9 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	49 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	16 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	60 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	452 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	9 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	1 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	2 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	13 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	15 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	8 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	17 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 participants
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	2 participants

Secondary

Change From Baseline to EoT in Mean Volume Voided Per Micturition

The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS. LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to EoT in Mean Volume Voided Per Micturition	8.44 mL	Standard Error 2.55
Mirabegron 25 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	13.32 mL	Standard Error 2.57
Mirabegron 50 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	21.99 mL	Standard Error 2.57
Solifenacin 5 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	30.99 mL	Standard Error 2.56
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	34.84 mL	Standard Error 1.81
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	39.73 mL	Standard Error 1.81

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00595% CI: [2.61, 14.89]ANCOVA

Secondary

Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS. LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-19.45 units on a scale	Standard Error 0.98
Mirabegron 25 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-23.93 units on a scale	Standard Error 0.99
Mirabegron 50 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-26.14 units on a scale	Standard Error 0.98
Solifenacin 5 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-26.44 units on a scale	Standard Error 0.98
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-31.06 units on a scale	Standard Error 0.69
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-32.24 units on a scale	Standard Error 0.7

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-8.17, -3.44]ANCOVA

Secondary

Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

The TS-VAS was a visual analogue scale which asked participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.

Time frame: Baseline and EoT (up to 12 weeks)

Population: FAS. LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	1.42 units on a scale	Standard Error 0.11
Mirabegron 25 mg	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.16 units on a scale	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.18 units on a scale	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.28 units on a scale	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.53 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.55 units on a scale	Standard Error 0.08

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous overactive bladder medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.0595% CI: [0, 0.55]ANCOVA

Secondary

Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

The WPAI:SHP was a self-administered questionnaire with 6 questions (Q1=Employment status; Q2=Hours absent from work due to the bladder condition; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the bladder condition on productivity while working; Q6=Impact of the bladder condition on productivity while doing regular daily activities other than work) and a 1-week recall period. WPAI outcomes were expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with both baseline and post-baseline values were included in the analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-2.98 percentage of work time missed	Standard Deviation 21.7
Placebo	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-2.96 percentage of work time missed	Standard Deviation 21.61
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-0.33 percentage of work time missed	Standard Deviation 22.03
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-0.33 percentage of work time missed	Standard Deviation 22.03
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-1.72 percentage of work time missed	Standard Deviation 18.7
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-1.71 percentage of work time missed	Standard Deviation 18.64
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-2.47 percentage of work time missed	Standard Deviation 14.13
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-2.44 percentage of work time missed	Standard Deviation 14.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-2.06 percentage of work time missed	Standard Deviation 20.93
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-1.48 percentage of work time missed	Standard Deviation 21.95
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Week 12	-2.59 percentage of work time missed	Standard Deviation 19.65
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	End of treatment	-2.55 percentage of work time missed	Standard Deviation 19.54

Secondary

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-11.49 percentage of activity impairment	Standard Deviation 27.31
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-11.55 percentage of activity impairment	Standard Deviation 27.19
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-16.89 percentage of activity impairment	Standard Deviation 27.57
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-16.72 percentage of activity impairment	Standard Deviation 27.82
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-14.99 percentage of activity impairment	Standard Deviation 27.81
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-15.05 percentage of activity impairment	Standard Deviation 27.95
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-16.19 percentage of activity impairment	Standard Deviation 29.16
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-16.05 percentage of activity impairment	Standard Deviation 28.95
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-19.60 percentage of activity impairment	Standard Deviation 28.8
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-19.45 percentage of activity impairment	Standard Deviation 28.8
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	Week 12	-18.92 percentage of activity impairment	Standard Deviation 29.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment	End of treatment	-18.76 percentage of activity impairment	Standard Deviation 29.33

Secondary

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-11.27 percentage of impairment while working	Standard Deviation 25.36
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-11.18 percentage of impairment while working	Standard Deviation 25.28
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-14.96 percentage of impairment while working	Standard Deviation 26.21
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-14.96 percentage of impairment while working	Standard Deviation 26.21
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-12.25 percentage of impairment while working	Standard Deviation 25.06
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-12.37 percentage of impairment while working	Standard Deviation 25.01
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-10.85 percentage of impairment while working	Standard Deviation 25.58
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-10.98 percentage of impairment while working	Standard Deviation 25.68
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-14.69 percentage of impairment while working	Standard Deviation 26.99
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-14.58 percentage of impairment while working	Standard Deviation 26.92
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Week 12	-13.07 percentage of impairment while working	Standard Deviation 27.35
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	End of treatment	-12.87 percentage of impairment while working	Standard Deviation 27.31

Secondary

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment

Time frame: Baseline and week 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-12.23 percentage of overall work impairment	Standard Deviation 25.66
Placebo	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-12.14 percentage of overall work impairment	Standard Deviation 25.58
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-15.70 percentage of overall work impairment	Standard Deviation 26.54
Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-15.70 percentage of overall work impairment	Standard Deviation 26.54
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-12.92 percentage of overall work impairment	Standard Deviation 26.71
Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-13.05 percentage of overall work impairment	Standard Deviation 26.65
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-12.31 percentage of overall work impairment	Standard Deviation 26.91
Solifenacin 5 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-12.42 percentage of overall work impairment	Standard Deviation 26.98
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-16.31 percentage of overall work impairment	Standard Deviation 29.06
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-16.07 percentage of overall work impairment	Standard Deviation 29.12
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	Week 12	-13.97 percentage of overall work impairment	Standard Deviation 29.3
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment	End of treatment	-13.76 percentage of overall work impairment	Standard Deviation 29.25

Secondary

Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Peak/trough difference was defined as the difference between the highest 1-h to lowest 1-h average per participant per visit.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	0.53 nnHg	Standard Error 1.3
Placebo	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	-0.76 nnHg	Standard Error 1.31
Placebo	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	0.87 nnHg	Standard Error 1.23
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	0.15 nnHg	Standard Error 1.34
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	-1.08 nnHg	Standard Error 1.4
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	0.27 nnHg	Standard Error 1.28
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	-1.90 nnHg	Standard Error 1.33
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	-0.20 nnHg	Standard Error 1.39
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	-0.96 nnHg	Standard Error 1.26
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	-0.66 nnHg	Standard Error 1.36
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	-1.60 nnHg	Standard Error 1.34
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	-1.67 nnHg	Standard Error 1.24
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	-1.24 nnHg	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	0.39 nnHg	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	-0.98 nnHg	Standard Error 0.89
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 4	-0.56 nnHg	Standard Error 0.91
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	End of treatment	0.52 nnHg	Standard Error 0.85
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference	Week 12	0.46 nnHg	Standard Error 0.9

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

Vital signs (blood pressure and pulse rate) were monitored using ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-1.17 mmHg	Standard Error 0.53
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	-0.41 mmHg	Standard Error 0.6
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	-0.12 mmHg	Standard Error 0.59
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	-0.49 mmHg	Standard Error 0.66
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	-0.96 mmHg	Standard Error 0.51
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.85 mmHg	Standard Error 0.6
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	-1.25 mmHg	Standard Error 0.53
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	-0.70 mmHg	Standard Error 0.5
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	-0.80 mmHg	Standard Error 0.56
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	-2.00 mmHg	Standard Error 0.63
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	-1.39 mmHg	Standard Error 0.71
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	-0.36 mmHg	Standard Error 0.58
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	-0.97 mmHg	Standard Error 0.62
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	-0.86 mmHg	Standard Error 0.54
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-0.98 mmHg	Standard Error 0.58
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	-0.93 mmHg	Standard Error 0.58
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	-1.41 mmHg	Standard Error 0.53
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.54 mmHg	Standard Error 0.64
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	-0.33 mmHg	Standard Error 0.57
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	-0.03 mmHg	Standard Error 0.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	-0.19 mmHg	Standard Error 0.57
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-0.69 mmHg	Standard Error 0.57
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	0.08 mmHg	Standard Error 0.63
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	0.40 mmHg	Standard Error 0.62
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	-0.11 mmHg	Standard Error 0.52
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.40 mmHg	Standard Error 0.65
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	0.22 mmHg	Standard Error 0.54
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	0.92 mmHg	Standard Error 0.71
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	0.25 mmHg	Standard Error 0.52
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	-0.77 mmHg	Standard Error 0.58
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	0.48 mmHg	Standard Error 0.63
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	0.43 mmHg	Standard Error 0.59
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.33 mmHg	Standard Error 0.66
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	0.05 mmHg	Standard Error 0.52
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-0.79 mmHg	Standard Error 0.57
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	0.71 mmHg	Standard Error 0.63
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.06 mmHg	Standard Error 0.46
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	-0.37 mmHg	Standard Error 0.41
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	-0.02 mmHg	Standard Error 0.37
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	0.93 mmHg	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	0.56 mmHg	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-0.18 mmHg	Standard Error 0.4
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	-0.40 mmHg	Standard Error 0.4
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	0.03 mmHg	Standard Error 0.37
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	0.23 mmHg	Standard Error 0.49
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: 24-hour mean	0.38 mmHg	Standard Error 0.35
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: 24-hour mean	0.31 mmHg	Standard Error 0.39
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean nighttime	0.49 mmHg	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean nighttime	0.61 mmHg	Standard Error 0.43
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: mean daytime	-0.36 mmHg	Standard Error 0.38
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	End of treatment: 24-hour mean	0.25 mmHg	Standard Error 0.35
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean nighttime	0.47 mmHg	Standard Error 0.42
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 12: mean daytime	-0.18 mmHg	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)	Week 4: mean daytime	0.07 mmHg	Standard Error 0.37

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	0.45 beats per minute (bpm)	Standard Error 0.74
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	0.39 beats per minute (bpm)	Standard Error 0.66
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	-0.72 beats per minute (bpm)	Standard Error 0.68
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	0.34 beats per minute (bpm)	Standard Error 0.71
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	0.41 beats per minute (bpm)	Standard Error 0.65
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	0.89 beats per minute (bpm)	Standard Error 0.82
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	-0.70 beats per minute (bpm)	Standard Error 0.73
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	-0.83 beats per minute (bpm)	Standard Error 0.63
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	0.70 beats per minute (bpm)	Standard Error 0.72
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	0.82 beats per minute (bpm)	Standard Error 0.69
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	0.21 beats per minute (bpm)	Standard Error 0.77
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	1.19 beats per minute (bpm)	Standard Error 0.79
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	0.98 beats per minute (bpm)	Standard Error 0.71
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	1.14 beats per minute (bpm)	Standard Error 0.68
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	0.37 beats per minute (bpm)	Standard Error 0.8
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	0.38 beats per minute (bpm)	Standard Error 0.74
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	0.63 beats per minute (bpm)	Standard Error 0.68
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	0.25 beats per minute (bpm)	Standard Error 0.88
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	3.52 beats per minute (bpm)	Standard Error 0.78
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	0.19 beats per minute (bpm)	Standard Error 0.73
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	1.19 beats per minute (bpm)	Standard Error 0.74
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	2.64 beats per minute (bpm)	Standard Error 0.79
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	0.75 beats per minute (bpm)	Standard Error 0.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	1.77 beats per minute (bpm)	Standard Error 0.7
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	1.67 beats per minute (bpm)	Standard Error 0.67
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	2.12 beats per minute (bpm)	Standard Error 0.89
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	2.32 beats per minute (bpm)	Standard Error 0.67
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	0.06 beats per minute (bpm)	Standard Error 0.76
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	0.36 beats per minute (bpm)	Standard Error 0.65
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	0.37 beats per minute (bpm)	Standard Error 0.8
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	1.09 beats per minute (bpm)	Standard Error 0.72
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	0.12 beats per minute (bpm)	Standard Error 0.76
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	-0.13 beats per minute (bpm)	Standard Error 0.9
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	0.02 beats per minute (bpm)	Standard Error 0.66
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	-0.07 beats per minute (bpm)	Standard Error 0.79
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	0.45 beats per minute (bpm)	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	0.84 beats per minute (bpm)	Standard Error 0.64
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	0.94 beats per minute (bpm)	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	0.85 beats per minute (bpm)	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	0.86 beats per minute (bpm)	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	1.21 beats per minute (bpm)	Standard Error 0.49
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	0.32 beats per minute (bpm)	Standard Error 0.56
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	-0.05 beats per minute (bpm)	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	0.40 beats per minute (bpm)	Standard Error 0.46
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	0.76 beats per minute (bpm)	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: 24-hour mean	0.69 beats per minute (bpm)	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: 24-hour mean	1.44 beats per minute (bpm)	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean nighttime	1.52 beats per minute (bpm)	Standard Error 0.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean nighttime	1.64 beats per minute (bpm)	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: mean daytime	1.24 beats per minute (bpm)	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	End of treatment: 24-hour mean	1.52 beats per minute (bpm)	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean nighttime	0.86 beats per minute (bpm)	Standard Error 0.48
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 12: mean daytime	1.36 beats per minute (bpm)	Standard Error 0.61
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)	Week 4: mean daytime	0.61 beats per minute (bpm)	Standard Error 0.51

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

Vital signs (blood pressure and pulse rate) were monitored using an ambulatory blood pressure monitoring (ABPM) device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPM analysis set (ABPMAS), which consisted of all participants in the SAF for whom at least 1 ABPM variable could be calculated at baseline and postbaseline visit. Participants with data available at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-2.01 mmHg	Standard Error 1.22
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	-1.00 mmHg	Standard Error 1.47
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	-0.51 mmHg	Standard Error 1.38
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	-1.03 mmHg	Standard Error 1.64
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	-1.73 mmHg	Standard Error 1.24
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-2.22 mmHg	Standard Error 1.37
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-1.55 mmHg	Standard Error 1.22
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	-1.00 mmHg	Standard Error 1.22
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	-1.97 mmHg	Standard Error 1.37
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	-3.48 mmHg	Standard Error 1.54
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	-2.81 mmHg	Standard Error 1.77
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-1.19 mmHg	Standard Error 1.33
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	-1.14 mmHg	Standard Error 1.46
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	-2.04 mmHg	Standard Error 1.31
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-3.29 mmHg	Standard Error 1.31
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	-2.70 mmHg	Standard Error 1.42
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	-3.44 mmHg	Standard Error 1.29
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-2.53 mmHg	Standard Error 1.46
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-0.67 mmHg	Standard Error 1.31
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	-0.77 mmHg	Standard Error 1.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	-1.75 mmHg	Standard Error 1.41
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-1.92 mmHg	Standard Error 1.3
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	-0.60 mmHg	Standard Error 1.52
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	1.42 mmHg	Standard Error 1.44
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	-1.14 mmHg	Standard Error 1.27
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-2.14 mmHg	Standard Error 1.48
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	0.96 mmHg	Standard Error 1.3
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	1.31 mmHg	Standard Error 1.76
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	1.03 mmHg	Standard Error 1.26
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-1.13 mmHg	Standard Error 1.34
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	0.41 mmHg	Standard Error 1.47
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	0.40 mmHg	Standard Error 1.45
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-2.09 mmHg	Standard Error 1.5
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	0.37 mmHg	Standard Error 1.25
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-2.17 mmHg	Standard Error 1.3
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	1.42 mmHg	Standard Error 1.52
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-0.39 mmHg	Standard Error 1.06
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	-0.71 mmHg	Standard Error 1.02
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	-0.52 mmHg	Standard Error 0.9
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	1.14 mmHg	Standard Error 1.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	0.41 mmHg	Standard Error 1.09
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-0.68 mmHg	Standard Error 0.92
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-1.63 mmHg	Standard Error 0.91
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	-0.85 mmHg	Standard Error 0.9
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	0.11 mmHg	Standard Error 1.23
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: 24-hour mean	0.31 mmHg	Standard Error 0.85
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: 24-hour mean	0.40 mmHg	Standard Error 0.95
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean nighttime	0.79 mmHg	Standard Error 1.17
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean nighttime	0.91 mmHg	Standard Error 1.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: mean daytime	-1.28 mmHg	Standard Error 0.87
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	End of treatment: 24-hour mean	-0.08 mmHg	Standard Error 0.85
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean nighttime	0.54 mmHg	Standard Error 0.98
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 12: mean daytime	-0.71 mmHg	Standard Error 1.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)	Week 4: mean daytime	-0.53 mmHg	Standard Error 0.85

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	-1.74 mmHg	Standard Error 0.92
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	-1.24 mmHg	Standard Error 0.84
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	-1.85 mmHg	Standard Error 0.84
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	-0.45 mmHg	Standard Error 1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	0.09 mmHg	Standard Error 0.93
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	-0.71 mmHg	Standard Error 0.88
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	-0.31 mmHg	Standard Error 0.97
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	-0.65 mmHg	Standard Error 0.86
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	-0.71 mmHg	Standard Error 0.85
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	-1.49 mmHg	Standard Error 1.01
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	-0.48 mmHg	Standard Error 0.87
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	-1.22 mmHg	Standard Error 0.86
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	0.48 mmHg	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	-0.22 mmHg	Standard Error 0.62
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	0.44 mmHg	Standard Error 0.61
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 4	-0.71 mmHg	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	End of treatment	-0.80 mmHg	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window	Week 12	-0.03 mmHg	Standard Error 0.68

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	0.10 bpm	Standard Error 1.1
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	-0.43 bpm	Standard Error 1.05
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	0.02 bpm	Standard Error 1.08
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	1.22 bpm	Standard Error 1.2
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	2.39 bpm	Standard Error 1.19
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	0.82 bpm	Standard Error 1.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	3.41 bpm	Standard Error 1.07
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	3.68 bpm	Standard Error 1.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	1.87 bpm	Standard Error 1.16
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	0.37 bpm	Standard Error 1.21
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	0.47 bpm	Standard Error 1.11
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	-1.25 bpm	Standard Error 1.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	0.15 bpm	Standard Error 0.81
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	-0.91 bpm	Standard Error 0.79
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	0.34 bpm	Standard Error 0.76
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	End of treatment	1.25 bpm	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 12	1.39 bpm	Standard Error 0.81
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window	Week 4	0.67 bpm	Standard Error 0.75

Secondary

Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	-4.86 mmHg	Standard Error 1.78
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	-2.71 mmHg	Standard Error 1.68
Placebo	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-4.40 mmHg	Standard Error 1.6
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	-2.13 mmHg	Standard Error 1.95
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	0.34 mmHg	Standard Error 1.86
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-2.19 mmHg	Standard Error 1.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	-1.64 mmHg	Standard Error 1.88
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	-1.03 mmHg	Standard Error 1.72
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-1.94 mmHg	Standard Error 1.64
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	-3.15 mmHg	Standard Error 1.96
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	-1.77 mmHg	Standard Error 1.74
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-3.64 mmHg	Standard Error 1.65
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	-0.26 mmHg	Standard Error 1.32
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	-1.55 mmHg	Standard Error 1.23
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-0.61 mmHg	Standard Error 1.16
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 4	-1.47 mmHg	Standard Error 1.17
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	End of treatment	-0.98 mmHg	Standard Error 1.12
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window	Week 12	0.60 mmHg	Standard Error 1.32

Secondary

Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	3.35 bpm	Standard Error 1.45
Placebo	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	1.16 bpm	Standard Error 1.38
Placebo	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	2.48 bpm	Standard Error 1.32
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	-0.04 bpm	Standard Error 1.5
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	0.46 bpm	Standard Error 1.48
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	0.45 bpm	Standard Error 1.37
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	1.15 bpm	Standard Error 1.49
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	1.54 bpm	Standard Error 1.46
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	1.14 bpm	Standard Error 1.35
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	3.49 bpm	Standard Error 1.53
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	0.78 bpm	Standard Error 1.41
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	3.16 bpm	Standard Error 1.33
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	-0.53 bpm	Standard Error 1.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	-0.68 bpm	Standard Error 1.01
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	-0.02 bpm	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 4	-0.51 bpm	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	End of treatment	1.80 bpm	Standard Error 0.91
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference	Week 12	1.48 bpm	Standard Error 1

Secondary

Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	1.18 mmHg	Standard Error 1.98
Placebo	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	-0.71 mmHg	Standard Error 1.86
Placebo	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	1.15 mmHg	Standard Error 1.83
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	-2.45 mmHg	Standard Error 2.05
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	0.14 mmHg	Standard Error 1.99
Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	-1.38 mmHg	Standard Error 1.91
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	-4.55 mmHg	Standard Error 2.03
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	-0.69 mmHg	Standard Error 1.98
Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	-2.30 mmHg	Standard Error 1.87
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	-1.63 mmHg	Standard Error 2.08
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	0.85 mmHg	Standard Error 1.91
Solifenacin 5 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	-0.97 mmHg	Standard Error 1.85
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	0.68 mmHg	Standard Error 1.47
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	-1.61 mmHg	Standard Error 1.36
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	0.25 mmHg	Standard Error 1.33
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 4	0.41 mmHg	Standard Error 1.29
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	End of treatment	0.68 mmHg	Standard Error 1.26
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference	Week 12	0.62 mmHg	Standard Error 1.37

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

The mean number of nocturia episodes per 24hr was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.17 nocturia episodes	Standard Error 0.04
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.27 nocturia episodes	Standard Error 0.04
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.26 nocturia episodes	Standard Error 0.04
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.27 nocturia episodes	Standard Error 0.04
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.38 nocturia episodes	Standard Error 0.04
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.37 nocturia episodes	Standard Error 0.04
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.31 nocturia episodes	Standard Error 0.04
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.40 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.39 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.39 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.35 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.25 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.24 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.39 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.36 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.41 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.49 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.48 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.44 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.33 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 8	-0.50 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 12	-0.56 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	End of treatmemt	-0.56 nocturia episodes	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Week 4	-0.35 nocturia episodes	Standard Error 0.03

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.06595% CI: [-0.19, 0.01]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [-0.26, -0.07]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.195% CI: [-0.18, 0.02]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [-0.26, -0.07]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours

The mean number of pads used per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8 and 12 (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 pad used at baseline were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-0.52 pads	Standard Error 0.1
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-0.82 pads	Standard Error 0.11
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-0.92 pads	Standard Error 0.11
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-0.94 pads	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-1.30 pads	Standard Error 0.11
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-1.20 pads	Standard Error 0.11
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-0.81 pads	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-1.26 pads	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-1.41 pads	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-1.37 pads	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-1.24 pads	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-1.12 pads	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-1.19 pads	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-1.53 pads	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-1.53 pads	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-1.56 pads	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-1.54 pads	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-1.53 pads	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-1.36 pads	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-1.09 pads	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 8	-1.51 pads	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 12	-1.59 pads	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	End of treatment	-1.58 pads	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Week 4	-1.23 pads	Standard Error 0.07

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.99395% CI: [-0.25, 0.25]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.6595% CI: [-0.3, 0.19]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.03595% CI: [-0.52, -0.02]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariatep-value: 0.16995% CI: [-0.43, 0.08]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

An urgency episode was a complaint of a sudden, compelling desire to pass urine, which was difficult to defer; it was recorded when a micturition or incontinence episode was recorded and the severity of urinary urgency recorded was 3 (severe urgency) or 4 (urgency incontinence) according to the Patient Perception of Intensity of Urgency Scale (PPIUS). The mean number of urgency episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency episode at baseline were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-1.34 urgency episodes	Standard Error 0.15
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-1.85 urgency episodes	Standard Error 0.15
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-2.05 urgency episodes	Standard Error 0.16
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-2.06 urgency episodes	Standard Error 0.15
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-2.85 urgency episodes	Standard Error 0.16
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-2.54 urgency episodes	Standard Error 0.15
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-1.95 urgency episodes	Standard Error 0.14
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-2.74 urgency episodes	Standard Error 0.15
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-2.63 urgency episodes	Standard Error 0.15
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-2.70 urgency episodes	Standard Error 0.16
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-2.43 urgency episodes	Standard Error 0.15
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-1.91 urgency episodes	Standard Error 0.15
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-2.14 urgency episodes	Standard Error 0.15
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-3.05 urgency episodes	Standard Error 0.15
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-2.90 urgency episodes	Standard Error 0.15
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-3.11 urgency episodes	Standard Error 0.16
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-3.45 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-3.38 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-3.13 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-2.42 urgency episodes	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 8	-3.28 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 12	-3.50 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	End of treatment	-3.51 urgency episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Week 4	-2.66 urgency episodes	Standard Error 0.1

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.07495% CI: [-0.69, 0.03]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.01495% CI: [-0.82, -0.09]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-1.01, -0.28]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-1.24, 0.51]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant per day on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-0.78 urgency incontinence episodes	Standard Error 0.09
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.15 urgency incontinence episodes	Standard Error 0.1
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.29 urgency incontinence episodes	Standard Error 0.1
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.33 urgency incontinence episodes	Standard Error 0.09
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.63 urgency incontinence episodes	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.43 urgency incontinence episodes	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-1.00 urgency incontinence episodes	Standard Error 0.09
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.58 urgency incontinence episodes	Standard Error 0.09
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.62 urgency incontinence episodes	Standard Error 0.09
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.67 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.44 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-1.15 urgency incontinence episodes	Standard Error 0.09
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-1.19 urgency incontinence episodes	Standard Error 0.09
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.71 urgency incontinence episodes	Standard Error 0.09
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.56 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.72 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.99 urgency incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.95 urgency incontinence episodes	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.74 urgency incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-1.35 urgency incontinence episodes	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 8	-1.79 urgency incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 12	-1.93 urgency incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	End of treatment	-1.94 urgency incontinence episodes	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Week 4	-1.47 urgency incontinence episodes	Standard Error 0.06

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.13495% CI: [-0.46, -0.02]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.04395% CI: [-0.45, -0.02]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.59, -0.15]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50mg ) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.0195% CI: [-0.54, -0.1]Stratified rank ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-5.23 incontinence episodes	Standard Error 0.66
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-8.79 incontinence episodes	Standard Error 0.71
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-9.05 incontinence episodes	Standard Error 0.72
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-9.42 incontinence episodes	Standard Error 0.68
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-12.33 incontinence episodes	Standard Error 0.72
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-10.57 incontinence episodes	Standard Error 0.72
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-7.59 incontinence episodes	Standard Error 0.66
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-11.93 incontinence episodes	Standard Error 0.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-12.39 incontinence episodes	Standard Error 0.68
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-12.58 incontinence episodes	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-10.97 incontinence episodes	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-8.99 incontinence episodes	Standard Error 0.67
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-8.92 incontinence episodes	Standard Error 0.67
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-12.65 incontinence episodes	Standard Error 0.68
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-11.89 incontinence episodes	Standard Error 0.72
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-12.75 incontinence episodes	Standard Error 0.71
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-14.50 incontinence episodes	Standard Error 0.51
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-14.29 incontinence episodes	Standard Error 0.48
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-12.53 incontinence episodes	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-9.62 incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 8	-12.78 incontinence episodes	Standard Error 0.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 12	-13.94 incontinence episodes	Standard Error 0.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	End of treatment	-13.98 incontinence episodes	Standard Error 0.48
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes	Week 4	-10.51 incontinence episodes	Standard Error 0.47

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.offset variable.p-value: 0.07495% CI: [-3.27, -0.01]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the solifenacin 5 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.02595% CI: [-2.96, 0.3]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 25 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-4, -0.73]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the mirabegron 50 mg monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.02495% CI: [-3.23, 0.05]Stratified rank ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

Time frame: Baseline and weeks 4, 8, 12, and EoT (up to 12 weeks)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-1.27 nocturia episodes	Standard Error 0.27
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-1.94 nocturia episodes	Standard Error 0.27
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-1.95 nocturia episodes	Standard Error 0.29
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-2.05 nocturia episodes	Standard Error 0.27
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-2.77 nocturia episodes	Standard Error 0.3
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-2.70 nocturia episodes	Standard Error 0.28
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-2.25 nocturia episodes	Standard Error 0.28
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-2.91 nocturia episodes	Standard Error 0.28
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-2.75 nocturia episodes	Standard Error 0.28
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-2.73 nocturia episodes	Standard Error 0.29
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-2.41 nocturia episodes	Standard Error 0.28
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-1.80 nocturia episodes	Standard Error 0.27
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-1.79 nocturia episodes	Standard Error 0.28
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-2.81 nocturia episodes	Standard Error 0.28
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-2.60 nocturia episodes	Standard Error 0.28
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-2.89 nocturia episodes	Standard Error 0.29
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-3.49 nocturia episodes	Standard Error 0.21
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-3.42 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-3.13 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-2.39 nocturia episodes	Standard Error 0.19
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 8	-3.48 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 12	-3.96 nocturia episodes	Standard Error 0.21
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	End of treatment	-3.96 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes	Week 4	-2.50 nocturia episodes	Standard Error 0.19

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.07395% CI: [-1.28, 0.06]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [-1.83, -0.48]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.1495% CI: [-1.18, 0.17]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-1.88, -0.54]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

Time frame: Baseline and weeks 4, 8, 12 and EOT (up to 12 weeks)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-3.69 pads	Standard Error 0.71
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-6.24 pads	Standard Error 0.77
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-6.29 pads	Standard Error 0.75
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-6.60 pads	Standard Error 0.71
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-9.06 pads	Standard Error 0.75
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-8.44 pads	Standard Error 0.77
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-5.68 pads	Standard Error 0.71
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-8.76 pads	Standard Error 0.71
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-9.80 pads	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-9.41 pads	Standard Error 0.75
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-8.43 pads	Standard Error 0.76
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-7.83 pads	Standard Error 0.71
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-8.23 pads	Standard Error 0.7
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-10.63 pads	Standard Error 0.7
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-10.67 pads	Standard Error 0.76
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-10.80 pads	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-10.66 pads	Standard Error 0.52
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-10.67 pads	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-9.49 pads	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-7.61 pads	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 8	-10.59 pads	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 12	-11.23 pads	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	End of treatment	-11.21 pads	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used	Week 4	-8.58 pads	Standard Error 0.5

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.95895% CI: [-1.73, 1.64]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.595% CI: [-2.27, 1.11]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.02895% CI: [-3.62, -0.2]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.10895% CI: [-3.13, 0.31]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-5.49 urgency incontinence episodes	Standard Error 0.63
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-8.30 urgency incontinence episodes	Standard Error 0.66
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-8.96 urgency incontinence episodes	Standard Error 0.65
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-9.26 urgency incontinence episodes	Standard Error 0.62
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-11.39 urgency incontinence episodes	Standard Error 0.66
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-9.93 urgency incontinence episodes	Standard Error 0.67
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-7.07 urgency incontinence episodes	Standard Error 0.63
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-11.03 urgency incontinence episodes	Standard Error 0.62
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-11.44 urgency incontinence episodes	Standard Error 0.62
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-11.66 urgency incontinence episodes	Standard Error 0.66
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-10.07 urgency incontinence episodes	Standard Error 0.67
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-8.39 urgency incontinence episodes	Standard Error 0.63
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-8.53 urgency incontinence episodes	Standard Error 0.63
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-12.03 urgency incontinence episodes	Standard Error 0.62
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-11.10 urgency incontinence episodes	Standard Error 0.67
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-12.10 urgency incontinence episodes	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-13.87 urgency incontinence episodes	Standard Error 0.46
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-13.64 urgency incontinence episodes	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-12.18 urgency incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-9.44 urgency incontinence episodes	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 8	-12.18 urgency incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 12	-13.53 urgency incontinence episodes	Standard Error 0.46
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	End of treatment	-13.64 urgency incontinence episodes	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes	Week 4	-10.23 urgency incontinence episodes	Standard Error 0.44

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.11495% CI: [-3.09, -0.13]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.03495% CI: [-3.1, -0.13]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-4.09, -1.12]Stratified rank ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.01295% CI: [-3.7, -0.71]Stratified rank ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The HRQoL portion in the OAB-q (seen in this outcome measure) consisted of 25 HRQL items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction), scored 1-6. The total HRQoL score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	10.16 units on a scale	Standard Error 0.83
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	14.51 units on a scale	Standard Error 0.88
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	15.76 units on a scale	Standard Error 0.92
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	15.37 units on a scale	Standard Error 0.88
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	19.59 units on a scale	Standard Error 0.93
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	17.95 units on a scale	Standard Error 0.89
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	13.54 units on a scale	Standard Error 0.83
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	18.94 units on a scale	Standard Error 0.89
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	21.00 units on a scale	Standard Error 0.89
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	21.48 units on a scale	Standard Error 0.92
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	18.54 units on a scale	Standard Error 0.88
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	15.28 units on a scale	Standard Error 0.83
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	14.78 units on a scale	Standard Error 0.83
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	20.15 units on a scale	Standard Error 0.89
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	18.57 units on a scale	Standard Error 0.88
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	20.54 units on a scale	Standard Error 0.91
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	24.63 units on a scale	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	23.96 units on a scale	Standard Error 0.63
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	22.30 units on a scale	Standard Error 0.62
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	17.46 units on a scale	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 8	22.45 units on a scale	Standard Error 0.62
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 12	24.93 units on a scale	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	End of treatment	24.30 units on a scale	Standard Error 0.63
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score	Week 4	17.95 units on a scale	Standard Error 0.59

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [1.69, 5.94]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.03, 6.29]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.88, 7.15]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00295% CI: [1.17, 5.43]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern

The Concern score was calculated by adding 7 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	11.24 units on a scale	Standard Error 0.95
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	16.10 units on a scale	Standard Error 0.99
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	17.53 units on a scale	Standard Error 1.03
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	16.98 units on a scale	Standard Error 1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	22.37 units on a scale	Standard Error 1.04
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	20.63 units on a scale	Standard Error 1.01
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	15.89 units on a scale	Standard Error 0.96
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	21.55 units on a scale	Standard Error 1.01
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	23.07 units on a scale	Standard Error 1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	23.62 units on a scale	Standard Error 1.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	20.55 units on a scale	Standard Error 1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	17.39 units on a scale	Standard Error 0.95
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	17.18 units on a scale	Standard Error 0.95
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	22.65 units on a scale	Standard Error 1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	20.96 units on a scale	Standard Error 0.99
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	23.19 units on a scale	Standard Error 1.03
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	27.53 units on a scale	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	26.89 units on a scale	Standard Error 0.71
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	25.26 units on a scale	Standard Error 0.71
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	20.48 units on a scale	Standard Error 0.67
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 8	25.65 units on a scale	Standard Error 0.7
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 12	28.24 units on a scale	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	End of treatment	27.47 units on a scale	Standard Error 0.71
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern	Week 4	21.09 units on a scale	Standard Error 0.67

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [1.84, 6.63]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.42, 7.22]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.93, 7.75]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.01, 6.81]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping

The Coping score was calculated by adding 8 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	11.74 units on a scale	Standard Error 0.99
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	16.13 units on a scale	Standard Error 1.04
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	18.17 units on a scale	Standard Error 1.09
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	17.73 units on a scale	Standard Error 1.05
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	22.04 units on a scale	Standard Error 1.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	20.64 units on a scale	Standard Error 1.05
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	14.87 units on a scale	Standard Error 1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	21.28 units on a scale	Standard Error 1.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	24.32 units on a scale	Standard Error 1.05
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	24.94 units on a scale	Standard Error 1.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	21.52 units on a scale	Standard Error 1.04
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	17.68 units on a scale	Standard Error 1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	16.52 units on a scale	Standard Error 1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	23.25 units on a scale	Standard Error 1.05
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	21.69 units on a scale	Standard Error 1.03
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	23.67 units on a scale	Standard Error 1.09
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	28.32 units on a scale	Standard Error 0.77
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	27.37 units on a scale	Standard Error 0.74
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	25.49 units on a scale	Standard Error 0.74
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	19.31 units on a scale	Standard Error 0.7
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 8	25.85 units on a scale	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 12	29.03 units on a scale	Standard Error 0.78
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	End of treatment	28.12 units on a scale	Standard Error 0.75
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping	Week 4	20.36 units on a scale	Standard Error 0.7

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00195% CI: [1.6, 6.65]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.34, 7.4]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [3.55, 8.63]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00395% CI: [1.27, 6.33]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep

The Sleep score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	9.28 units on a scale	Standard Error 0.95
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	13.58 units on a scale	Standard Error 1.03
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	14.40 units on a scale	Standard Error 1.05
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	14.17 units on a scale	Standard Error 1.01
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	18.04 units on a scale	Standard Error 1.06
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	16.39 units on a scale	Standard Error 1.05
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	12.70 units on a scale	Standard Error 0.96
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	17.51 units on a scale	Standard Error 1.02
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	19.11 units on a scale	Standard Error 1.02
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	19.16 units on a scale	Standard Error 1.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	17.33 units on a scale	Standard Error 1.03
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	13.80 units on a scale	Standard Error 0.96
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	13.08 units on a scale	Standard Error 0.96
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	17.97 units on a scale	Standard Error 1.01
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	16.43 units on a scale	Standard Error 1.03
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	18.35 units on a scale	Standard Error 1.05
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	22.97 units on a scale	Standard Error 0.74
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	22.39 units on a scale	Standard Error 0.72
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	20.29 units on a scale	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	15.97 units on a scale	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 8	20.49 units on a scale	Standard Error 0.73
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 12	22.76 units on a scale	Standard Error 0.75
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	End of treatment	22.39 units on a scale	Standard Error 0.72
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep	Week 4	16.66 units on a scale	Standard Error 0.68

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [1.98, 6.85]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [1.98, 6.86]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.42, 7.32]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00895% CI: [0.84, 5.72]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social

The Social score was calculated by adding 5 response scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	7.07 units on a scale	Standard Error 0.78
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	10.65 units on a scale	Standard Error 0.82
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	10.84 units on a scale	Standard Error 0.83
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	10.56 units on a scale	Standard Error 0.81
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	13.43 units on a scale	Standard Error 0.84
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	11.50 units on a scale	Standard Error 0.83
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	9.04 units on a scale	Standard Error 0.79
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	13.04 units on a scale	Standard Error 0.81
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	14.87 units on a scale	Standard Error 0.81
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	15.35 units on a scale	Standard Error 0.84
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	12.34 units on a scale	Standard Error 0.82
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	10.19 units on a scale	Standard Error 0.78
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	9.89 units on a scale	Standard Error 0.78
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	13.57 units on a scale	Standard Error 0.81
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	12.02 units on a scale	Standard Error 0.81
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	13.74 units on a scale	Standard Error 0.83
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	16.16 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	15.84 units on a scale	Standard Error 0.57
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	14.89 units on a scale	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	11.55 units on a scale	Standard Error 0.55
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 8	14.73 units on a scale	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 12	16.08 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	End of treatment	15.82 units on a scale	Standard Error 0.57
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social	Week 4	11.25 units on a scale	Standard Error 0.55

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.02295% CI: [0.33, 4.21]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.02395% CI: [0.31, 4.19]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00595% CI: [0.85, 4.74]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: 0.33795% CI: [-0.99, 2.89]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. Participants assessed their bladder condition using this scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.

Time frame: Baseline and weeks 4, 8, 12, EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT .

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-0.54 units on a scale	Standard Error 0.06
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-0.80 units on a scale	Standard Error 0.06
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-0.95 units on a scale	Standard Error 0.06
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-0.91 units on a scale	Standard Error 0.06
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-1.23 units on a scale	Standard Error 0.06
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-1.07 units on a scale	Standard Error 0.06
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-0.72 units on a scale	Standard Error 0.06
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-1.18 units on a scale	Standard Error 0.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-1.31 units on a scale	Standard Error 0.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-1.34 units on a scale	Standard Error 0.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-1.12 units on a scale	Standard Error 0.06
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-0.83 units on a scale	Standard Error 0.06
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-0.81 units on a scale	Standard Error 0.06
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-1.27 units on a scale	Standard Error 0.06
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-1.18 units on a scale	Standard Error 0.06
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-1.32 units on a scale	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-1.57 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-1.53 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-1.32 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-0.99 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 8	-1.48 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 12	-1.72 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	End of treatment	-1.66 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)	Week 4	-1.07 units on a scale	Standard Error 0.04

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.41, -0.11]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (solifenacin 5 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.54, -0.25]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 25 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 25 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.5, -0.2]ANCOVA

Comparison: Difference of the adjusted mean calculated by subtracting the adjusted mean of the monotherapy group (mirabegron 50 mg) from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.5, -0.2]ANCOVA

Secondary

Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or a bladder scanner.

Time frame: Baseline and weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: SAF participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	-1.0 mL	Standard Deviation 29.4
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	-1.0 mL	Standard Deviation 29.9
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	-1.9 mL	Standard Deviation 28.6
Placebo	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	-0.8 mL	Standard Deviation 29.9
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	-0.4 mL	Standard Deviation 29.8
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	1.6 mL	Standard Deviation 28
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	0.7 mL	Standard Deviation 29.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	1.0 mL	Standard Deviation 29.8
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	-0.6 mL	Standard Deviation 34.4
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	-2.1 mL	Standard Deviation 29.7
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	-0.8 mL	Standard Deviation 30
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	0.0 mL	Standard Deviation 30.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	5.4 mL	Standard Deviation 35.2
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	4.8 mL	Standard Deviation 33.3
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	5.8 mL	Standard Deviation 35.6
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	4.7 mL	Standard Deviation 33.1
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	7.2 mL	Standard Deviation 47.7
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	7.0 mL	Standard Deviation 37.4
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	7.9 mL	Standard Deviation 44.4
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	9.0 mL	Standard Deviation 55
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 8	9.9 mL	Standard Deviation 46
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 4	10.6 mL	Standard Deviation 51.1
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	End of treatment	11.0 mL	Standard Deviation 54.9
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume	Week 12	9.6 mL	Standard Deviation 50.1

Secondary

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

Time frame: Baseline and weeks 4, 8 and 12

Population: FAS participants with available data at each time point were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.20 incontinence episodes	Standard Error 0.1
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-0.74 incontinence episodes	Standard Error 0.1
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-1.30 incontinence episodes	Standard Error 0.11
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.51 incontinence episodes	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-1.07 incontinence episodes	Standard Error 0.1
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-1.76 incontinence episodes	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.57 incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-1.24 incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-1.81 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.66 incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-1.24 incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-1.80 incontinence episodes	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.79 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-1.38 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-2.08 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 4	-1.50 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 12	-1.98 incontinence episodes	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Week 8	-1.84 incontinence episodes	Standard Error 0.07

Secondary

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours

Time frame: Baseline and weeks 4, 8 and 12

Population: FAS participants with available data at each time point data were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-1.43 micturitions	Standard Error 0.11
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.02 micturitions	Standard Error 0.11
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-1.51 micturitions	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-1.95 micturitions	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.46 micturitions	Standard Error 0.11
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-2.01 micturitions	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-1.89 micturitions	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.44 micturitions	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-2.03 micturitions	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-1.84 micturitions	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.39 micturitions	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-2.22 micturitions	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-2.23 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.67 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-2.47 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 4	-1.91 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 12	-2.60 micturitions	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours	Week 8	-2.42 micturitions	Standard Error 0.08

Secondary

Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition

Time frame: Baseline and weeks 4, 8 and 12

Population: FAS participants with available data at each time point were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	9.00 mL	Standard Error 2.48
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	6.95 mL	Standard Error 2.13
Placebo	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	8.70 mL	Standard Error 2.7
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	10.96 mL	Standard Error 2.52
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	10.08 mL	Standard Error 2.14
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	12.88 mL	Standard Error 2.74
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	17.73 mL	Standard Error 2.53
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	15.52 mL	Standard Error 2.14
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	22.40 mL	Standard Error 2.73
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	27.55 mL	Standard Error 2.5
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	24.23 mL	Standard Error 2.15
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	31.89 mL	Standard Error 2.68
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	32.94 mL	Standard Error 1.78
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	25.54 mL	Standard Error 1.51
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	35.52 mL	Standard Error 1.9
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 4	28.99 mL	Standard Error 1.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 12	41.28 mL	Standard Error 1.9
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition	Week 8	36.51 mL	Standard Error 1.77

Secondary

Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

The OAB-q was a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion in the OAB-q (seen in this outcome measure) consisted of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.

Time frame: Baseline and weeks 4, 8 and 12

Population: FAS participants with available data at each time point were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-17.35 units on a scale	Standard Error 0.98
Placebo	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-13.84 units on a scale	Standard Error 0.92
Placebo	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-19.94 units on a scale	Standard Error 1.01
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-22.79 units on a scale	Standard Error 0.99
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-17.05 units on a scale	Standard Error 0.93
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-24.44 units on a scale	Standard Error 1.02
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-23.54 units on a scale	Standard Error 0.98
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-18.98 units on a scale	Standard Error 0.93
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-26.80 units on a scale	Standard Error 1.02
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-24.69 units on a scale	Standard Error 0.97
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-19.53 units on a scale	Standard Error 0.93
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-26.72 units on a scale	Standard Error 1.01
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-29.10 units on a scale	Standard Error 0.69
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-23.46 units on a scale	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-31.70 units on a scale	Standard Error 0.72
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 4	-25.19 units on a scale	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 12	-33.15 units on a scale	Standard Error 0.72
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score	Week 8	-30.04 units on a scale	Standard Error 0.69

Secondary

Change From Baseline to Weeks 4, 8 and 12 in TS-VAS

Time frame: Baseline and week 4, 8 and 12

Population: FAS participants with available data at each time point were included in the analysis.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	1.50 units on a scale	Standard Error 0.11
Placebo	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	1.14 units on a scale	Standard Error 0.12
Placebo	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	1.47 units on a scale	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	2.16 units on a scale	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	1.68 units on a scale	Standard Error 0.12
Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	2.24 units on a scale	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	2.09 units on a scale	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	1.77 units on a scale	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	2.23 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	2.20 units on a scale	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	1.82 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	2.32 units on a scale	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	2.48 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	2.06 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	2.58 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 4	2.13 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 12	2.63 units on a scale	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Weeks 4, 8 and 12 in TS-VAS	Week 8	2.48 units on a scale	Standard Error 0.08

Secondary

Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Population: ABPMAS participants with available data at each time point were included in the analysis. Only participants with an increase (i.e., maximum 1-hour change from time-matched baseline ≥ 0 mmHg) were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	19.68 mmHg	Standard Error 1.23
Placebo	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	18.78 mmHg	Standard Error 1.27
Placebo	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	20.29 mmHg	Standard Error 1.16
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	19.52 mmHg	Standard Error 1.28
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	19.15 mmHg	Standard Error 1.36
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	19.29 mmHg	Standard Error 1.22
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	20.41 mmHg	Standard Error 1.27
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	20.41 mmHg	Standard Error 1.35
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	20.71 mmHg	Standard Error 1.19
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	21.18 mmHg	Standard Error 1.3
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	20.02 mmHg	Standard Error 1.31
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	20.47 mmHg	Standard Error 1.18
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	19.26 mmHg	Standard Error 0.92
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	20.74 mmHg	Standard Error 0.93
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	20.29 mmHg	Standard Error 0.85
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 4	20.27 mmHg	Standard Error 0.88
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	End of treatment	20.36 mmHg	Standard Error 0.8
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT	Week 12	20.01 mmHg	Standard Error 0.85

Secondary

Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. Tmax window of mirabegron and solifenacin was from 4-6 hours postdose. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	22.63 bpm	Standard Error 1.42
Placebo	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	22.34 bpm	Standard Error 1.35
Placebo	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	23.01 bpm	Standard Error 1.31
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	23.54 bpm	Standard Error 1.47
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	23.86 bpm	Standard Error 1.44
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	24.12 bpm	Standard Error 1.37
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	26.03 bpm	Standard Error 1.46
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	25.12 bpm	Standard Error 1.43
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	26.23 bpm	Standard Error 1.34
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	23.52 bpm	Standard Error 1.5
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	24.28 bpm	Standard Error 1.38
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	23.33 bpm	Standard Error 1.33
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	22.60 bpm	Standard Error 1.05
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	21.48 bpm	Standard Error 0.99
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	22.66 bpm	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 4	21.80 bpm	Standard Error 0.94
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	End of treatment	24.14 bpm	Standard Error 0.9
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT	Week 12	24.08 bpm	Standard Error 0.98

Secondary

Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT

Vital signs (blood pressure and pulse rate) were monitored using an ABPM device placed on the upper arm followed by intake of the double-blind study medication and worn for at least 24 hours. The maximum 1 hour change from time-matched baseline was calculated as the maximum difference between the post-baseline hourly means and the time-matched baseline hourly means.

Time frame: Baseline and weeks 4, 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Placebo	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	33.21 mmHg	Standard Error 2.3
Placebo	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	34.05 mmHg	Standard Error 2.06
Placebo	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	34.98 mmHg	Standard Error 2.11
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	30.68 mmHg	Standard Error 2.38
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	31.14 mmHg	Standard Error 2.2
Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	30.65 mmHg	Standard Error 2.2
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	32.88 mmHg	Standard Error 2.36
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	38.20 mmHg	Standard Error 2.19
Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	33.53 mmHg	Standard Error 2.16
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	35.11 mmHg	Standard Error 2.42
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	35.16 mmHg	Standard Error 2.11
Solifenacin 5 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	34.95 mmHg	Standard Error 2.14
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	33.53 mmHg	Standard Error 1.7
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	32.88 mmHg	Standard Error 1.51
Solifenacin 5 mg + Mirabegron 25 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	34.70 mmHg	Standard Error 1.54
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 4	32.80 mmHg	Standard Error 1.43
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	End of treatment	32.55 mmHg	Standard Error 1.45
Solifenacin 5 mg + Mirabegron 50 mg	Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT	Week 12	32.82 mmHg	Standard Error 1.59

Secondary

Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with less than 8 micturitions per day.

Time frame: Weeks 4, 8,12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.49 days	Standard Error 0.1
Placebo	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.69 days	Standard Error 0.1
Placebo	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	1.76 days	Standard Error 0.11
Placebo	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	1.80 days	Standard Error 0.11
Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.31 days	Standard Error 0.13
Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	2.08 days	Standard Error 0.12
Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.74 days	Standard Error 0.1
Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.28 days	Standard Error 0.12
Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.22 days	Standard Error 0.12
Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.25 days	Standard Error 0.12
Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.99 days	Standard Error 0.11
Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.55 days	Standard Error 0.1
Solifenacin 5 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.86 days	Standard Error 0.11
Solifenacin 5 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.49 days	Standard Error 0.12
Solifenacin 5 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	2.22 days	Standard Error 0.12
Solifenacin 5 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.49 days	Standard Error 0.13
Solifenacin 5 mg + Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.87 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.84 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	2.59 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 25 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	2.07 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	2.70 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.95 days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.92 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	2.11 days	Standard Error 0.08

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.03995% CI: [1.01, 1.5]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00995% CI: [1.07, 1.59]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: <0.00195% CI: [1.19, 1.77]overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariatep-value: <0.00195% CI: [1.23, 1.84]Overdispersed binomial regression

Secondary

Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

The number of incontinence episodes was calculated as the total number of incontinence episodes on valid diary days recorded during the 7-day micturition diary period.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	18.09 incontinence episodes	Standard Error 1.17
Placebo	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	14.45 incontinence episodes	Standard Error 1.12
Placebo	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	14.06 incontinence episodes	Standard Error 1.17
Placebo	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	13.70 incontinence episodes	Standard Error 1.08
Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	10.60 incontinence episodes	Standard Error 0.98
Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	12.84 incontinence episodes	Standard Error 1.05
Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	15.65 incontinence episodes	Standard Error 1.08
Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	11.19 incontinence episodes	Standard Error 0.95
Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	9.79 incontinence episodes	Standard Error 0.94
Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	9.50 incontinence episodes	Standard Error 0.98
Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	11.31 incontinence episodes	Standard Error 1.09
Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	12.90 incontinence episodes	Standard Error 1.06
Solifenacin 5 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	15.31 incontinence episodes	Standard Error 1.11
Solifenacin 5 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	11.21 incontinence episodes	Standard Error 0.98
Solifenacin 5 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	12.19 incontinence episodes	Standard Error 1.06
Solifenacin 5 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	11.25 incontinence episodes	Standard Error 1.03
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	7.62 incontinence episodes	Standard Error 0.57
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.02 incontinence episodes	Standard Error 0.55
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	9.70 incontinence episodes	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	12.51 incontinence episodes	Standard Error 0.67
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	9.33 incontinence episodes	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.21 incontinence episodes	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.18 incontinence episodes	Standard Error 0.64
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	11.44 incontinence episodes	Standard Error 0.7

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.p-value: 0.13595% CI: [0.72, 1.04]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.p-value: 0.28295% CI: [0.75, 1.09]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, ≥65 years), geographic region and previous OAB medication (yes, no) as factors, log(number of incontinence episodes used divided by number of valid diary days) at baseline included as a covariate and number of valid diary days at EoT as the offset variable.p-value: <0.00195% CI: [0.59, 0.85]Negative binomial regression

Secondary

Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	2.25 incontinence-free days	Standard Error 0.13
Placebo	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	2.92 incontinence-free days	Standard Error 0.14
Placebo	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	3.19 incontinence-free days	Standard Error 0.15
Placebo	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	3.16 incontinence-free days	Standard Error 0.14
Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	3.69 incontinence-free days	Standard Error 0.15
Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	3.17 incontinence-free days	Standard Error 0.14
Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	2.48 incontinence-free days	Standard Error 0.13
Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	3.51 incontinence-free days	Standard Error 0.14
Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	3.89 incontinence-free days	Standard Error 0.14
Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	3.96 incontinence-free days	Standard Error 0.15
Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	3.63 incontinence-free days	Standard Error 0.15
Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	2.98 incontinence-free days	Standard Error 0.13
Solifenacin 5 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	2.74 incontinence-free days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	3.61 incontinence-free days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	3.31 incontinence-free days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	3.68 incontinence-free days	Standard Error 0.14
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	4.33 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	4.20 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	3.88 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	3.08 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 8	4.01 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 12	4.25 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	End of treatment	4.23 incontinence-free days	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT	Week 4	3.37 incontinence-free days	Standard Error 0.1

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00395% CI: [1.11, 1.68]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00495% CI: [1.11, 1.68]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.p-value: <0.00195% CI: [1.29, 1.95]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline logarithm of mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00495% CI: [1.1, 1.68]Overdispersed binomial regression

Secondary

Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

The number of incontinence-free days with \< 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with \< 8 micturitions per day.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	0.64 days	Standard Error 0.07
Placebo	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	0.85 days	Standard Error 0.08
Placebo	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	0.98 days	Standard Error 0.09
Placebo	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	1.01 days	Standard Error 0.08
Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	1.47 days	Standard Error 0.11
Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.20 days	Standard Error 0.1
Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	0.84 days	Standard Error 0.08
Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	1.40 days	Standard Error 0.1
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	1.47 days	Standard Error 0.1
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	1.50 days	Standard Error 0.11
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.23 days	Standard Error 0.1
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	0.87 days	Standard Error 0.08
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	0.91 days	Standard Error 0.08
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	1.59 days	Standard Error 0.1
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.31 days	Standard Error 0.1
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	1.60 days	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.12 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.04 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.75 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 25 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.21 days	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 8	1.89 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 12	2.15 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	End of treatment	2.12 days	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT	Week 4	1.32 days	Standard Error 0.07

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.01195% CI: [1.07, 1.64]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00295% CI: [1.14, 1.75]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: <0.00195% CI: [1.32, 2.06]Overdispersed binomial regression

Comparison: Odds ratio from a overdispersed binomial regression model (Williams' method) including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: <0.00195% CI: [1.33, 2.07]Overdispersed binomial regression

Secondary

Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant went to bed with the intention to sleep until the time the patients got up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	9.62 nocturia episodes	Standard Error 0.43
Placebo	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	8.99 nocturia episodes	Standard Error 0.44
Placebo	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.91 nocturia episodes	Standard Error 0.43
Placebo	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.83 nocturia episodes	Standard Error 0.42
Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	7.99 nocturia episodes	Standard Error 0.37
Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	8.07 nocturia episodes	Standard Error 0.34
Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	8.46 nocturia episodes	Standard Error 0.36
Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	7.79 nocturia episodes	Standard Error 0.35
Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.14 nocturia episodes	Standard Error 0.45
Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.34 nocturia episodes	Standard Error 0.48
Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	8.61 nocturia episodes	Standard Error 0.45
Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	9.11 nocturia episodes	Standard Error 0.47
Solifenacin 5 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	9.22 nocturia episodes	Standard Error 0.42
Solifenacin 5 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.12 nocturia episodes	Standard Error 0.37
Solifenacin 5 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	8.37 nocturia episodes	Standard Error 0.38
Solifenacin 5 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.17 nocturia episodes	Standard Error 0.39
Solifenacin 5 mg + Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	7.26 nocturia episodes	Standard Error 0.24
Solifenacin 5 mg + Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	7.33 nocturia episodes	Standard Error 0.24
Solifenacin 5 mg + Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	7.63 nocturia episodes	Standard Error 0.25
Solifenacin 5 mg + Mirabegron 25 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	8.40 nocturia episodes	Standard Error 0.25
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 8	7.11 nocturia episodes	Standard Error 0.24
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 12	6.67 nocturia episodes	Standard Error 0.23
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	End of treatment	6.67 nocturia episodes	Standard Error 0.22
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT	Week 4	8.09 nocturia episodes	Standard Error 0.25

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.00695% CI: [0.81, 0.96]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: <0.00195% CI: [0.74, 0.88]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.04995% CI: [0.84, 1]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of nocturia episodes used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.00195% CI: [0.79, 0.94]Negative binomial regression

Secondary

Number of Pads Used at Weeks 4, 8, 12 and EoT

The number of pads used was the number of times a participant recorded a new pad used on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8 and 12 (up to 12 weeks)

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	15.62 pads	Standard Error 1.33
Placebo	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	12.62 pads	Standard Error 1.21
Placebo	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	12.75 pads	Standard Error 1.22
Placebo	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	12.29 pads	Standard Error 1.11
Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	9.65 pads	Standard Error 1
Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	13.46 pads	Standard Error 1.24
Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	10.79 pads	Standard Error 1.05
Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	10.15 pads	Standard Error 0.97
Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	8.16 pads	Standard Error 1.17
Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	10.05 pads	Standard Error 1.21
Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	8.44 pads	Standard Error 1.26
Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	9.53 pads	Standard Error 1.39
Solifenacin 5 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	8.45 pads	Standard Error 1.03
Solifenacin 5 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	8.53 pads	Standard Error 0.94
Solifenacin 5 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	11.41 pads	Standard Error 1.23
Solifenacin 5 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	8.21 pads	Standard Error 0.95
Solifenacin 5 mg + Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	9.71 pads	Standard Error 0.7
Solifenacin 5 mg + Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	7.04 pads	Standard Error 0.56
Solifenacin 5 mg + Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	8.07 pads	Standard Error 0.65
Solifenacin 5 mg + Mirabegron 25 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	6.60 pads	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	End of treatment	6.80 pads	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 12	6.64 pads	Standard Error 0.61
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 4	9.34 pads	Standard Error 0.68
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used at Weeks 4, 8, 12 and EoT	Week 8	7.58 pads	Standard Error 0.62

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.93895% CI: [0.8, 1.27]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.96795% CI: [0.79, 1.25]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.00895% CI: [0.58, 0.92]Negative binomial regression

Comparison: Rate ratio of number of incontinence episodes during the 7-day diary between the given combination group and the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65, \>=65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of pads used divided by number of valid diary days) included as a covariate and postbaseline number of valid diary days as offset variable.p-value: 0.06995% CI: [0.64, 1.02]Negative binomial regression

Secondary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

A TEAE refered to an adverse event (AE; defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment) which started or worsened in the period from first double-blind medication intake until 14 days after the last double-blind medication intake. Serious TEAEs with a start date reported until 30 days after the last double-blind medication intake were also summarized as TEAEs, and also included serious TEAEs upgraded by the sponsor based on review of the sponsor's list of Always Serious terms if any upgrade was done. Drug-related TEAEs may be possible or probable, as assessed by the investigator, or records where relationship is missing.

Time frame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 16 weeks)

Population: Safety Analysis Set (SAF), which comprised all randomized participants who received ≥ 1 dose of double-blind treatment and excluded participants from one site.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	145 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	0 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	45 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	7 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	9 Participants
Placebo	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	8 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	37 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	6 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	1 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	135 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	4 Participants
Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	7 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	52 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	147 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	1 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	10 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	5 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	6 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	3 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	149 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	63 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	0 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	7 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	5 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	157 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	17 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	345 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	20 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	12 Participants
Solifenacin 5 mg + Mirabegron 25 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs leading to discontinuation	19 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related serious TEAEs	3 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Deaths	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	150 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs leading to discontinuation	22 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAE	314 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	19 Participants

Secondary

Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the number of times a participant recorded an urgency incontinence episode on valid diary days during the 7-day micturition diary period prior to each visit.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis.

Arm	Measure	Group	Value (MEAN)	Dispersion
Placebo	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	15.76 urgency incontinence episodes	Standard Error 1.1
Placebo	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	12.77 urgency incontinence episodes	Standard Error 1.07
Placebo	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	12.00 urgency incontinence episodes	Standard Error 1.09
Placebo	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	11.69 urgency incontinence episodes	Standard Error 1
Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.84 urgency incontinence episodes	Standard Error 0.89
Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	10.65 urgency incontinence episodes	Standard Error 0.94
Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	13.36 urgency incontinence episodes	Standard Error 0.99
Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	9.37 urgency incontinence episodes	Standard Error 0.86
Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	8.63 urgency incontinence episodes	Standard Error 0.89
Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	8.32 urgency incontinence episodes	Standard Error 0.94
Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	10.09 urgency incontinence episodes	Standard Error 1.02
Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	11.46 urgency incontinence episodes	Standard Error 1
Solifenacin 5 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	13.19 urgency incontinence episodes	Standard Error 1.06
Solifenacin 5 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	9.29 urgency incontinence episodes	Standard Error 0.91
Solifenacin 5 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	10.41 urgency incontinence episodes	Standard Error 1
Solifenacin 5 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	9.29 urgency incontinence episodes	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	5.86 urgency incontinence episodes	Standard Error 0.46
Solifenacin 5 mg + Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	6.25 urgency incontinence episodes	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	7.58 urgency incontinence episodes	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 25 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	10.22 urgency incontinence episodes	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 8	7.31 urgency incontinence episodes	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 12	6.27 urgency incontinence episodes	Standard Error 0.49
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	End of treatment	6.15 urgency incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT	Week 4	9.33 urgency incontinence episodes	Standard Error 0.58

Comparison: Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.p-value: 0.1195% CI: [0.7, 1.04]Negative binomial regression

Comparison: Rate ratio of number of urgency incontinence episodes during the 7-day diary bet. the given combination group \& the given monotherapy group calculated from a negative binomial regression model incl. treatment group, sex, age group (\<65,≥ 65 years), geographic region and previous OAB medication (yes, no) as factors, baseline log(number of urgency incontinence episodes used divided by number of valid diary days) included as a covariate \& postbaseline number of valid diary days as offset variable.p-value: <0.00195% CI: [0.53, 0.79]Negative binomial regression

Secondary

Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

The PGIC was a 2-part questionnaire, assessing both the change in the patient's overall condition and change in bladder condition since the start of the study (from very much worse to very much improved).

Time frame: Week 12 and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	1.0 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	18.2 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	29.7 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	17.5 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	4.1 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	8.4 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	29.9 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	29.7 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	30.4 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	4.1 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	1.0 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.5 percentage of participants
Placebo	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	8.4 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	13.9 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	1.0 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	1.0 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	32.9 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	13.9 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	1.5 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	26.8 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.5 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	13.4 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	26.8 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	12.9 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	33.2 percentage of participants
Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	1.5 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	9.7 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	15.1 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	34.8 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	26.5 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	2.2 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	1.2 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.7 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	15.1 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	34.8 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	27.0 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	10.2 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	2.2 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	1.2 percentage of participants
Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.7 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	13.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	26.3 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	0.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	0.7 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	25.8 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	9.6 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	13.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	41.0 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	1.7 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	40.5 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	8.9 percentage of participants
Solifenacin 5 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	1.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	0.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	20.0 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	7.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	19.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	40.0 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	22.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	22.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	7.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	39.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	0.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	0.4 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally worse	0.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally worse	0.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much improved	34.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much improved	27.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: No change	7.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Much worse	0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much worse	0.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much worse	0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: No change	7.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Much improved	34.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Very much improved	27.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	EoT: Minimally improved	21.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT	Week 12: Minimally improved	20.7 percentage of participants

Secondary

Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT

The percentage of participants with micturition frequency normalization was defined as any participant who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 h postbaseline at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8 , 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	24.1 percentage of participants
Placebo	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	28.7 percentage of participants
Placebo	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	29.7 percentage of participants
Placebo	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	31.1 percentage of participants
Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	42.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	37.9 percentage of participants
Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	30.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	42.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	40.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	40.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	34.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	25.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	31.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	45.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	37.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	44.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	50.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	51.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	45.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	36.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 8	49.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 12	53.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	End of treatment	52.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT	Week 4	37.7 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.04495% CI: [1.01, 1.67]Logistic regression

Secondary

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and minimal important difference reached (improvement by ≥ 10 points) on the OAB-q HRQL total score at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	23.2 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	32.9 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	39.2 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	39.1 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	48.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	43.2 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	28.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	46.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	52.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	53.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	46.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	39.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	37.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	54.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	48.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	54.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	61.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	59.0 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	54.1 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	40.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 8	53.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 12	59.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	End of treatment	58.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q HRQL Total Score) at Weeks 4, 8, 12 and EoT	Week 4	40.5 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.p-value: 0.09595% CI: [0.96, 1.59]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.p-value: 0.07395% CI: [0.98, 1.62]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.p-value: <0.00195% CI: [1.29, 2.13]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q HRQL total score as covariates.p-value: 0.06795% CI: [0.98, 1.63]Logistic regression

Secondary

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	28.6 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	39.8 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	45.0 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	45.2 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	55.7 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	50.0 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	34.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	54.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	58.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	59.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	51.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	45.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	44.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	62.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	56.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	63.1 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	66.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	65.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	63.1 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	47.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 8	63.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 12	69.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	End of treatment	68.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 10 Points Improvement on OAB-q Symptom Bother Scale) at Weeks 4, 8, 12 and EoT	Week 4	52.3 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.p-value: 0.38195% CI: [0.87, 1.45]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.p-value: 0.0495% CI: [1.01, 1.7]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.p-value: 0.00195% CI: [1.21, 2]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours and baseline OAB-q symptom bother scale as covariates.p-value: 0.00195% CI: [1.21, 2.03]Logistic regression

Secondary

Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as double responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	23.2 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	35.6 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	40.6 percentage of participants
Placebo	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	40.9 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	51.7 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	44.7 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	27.9 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	48.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	53.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	54.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	50.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	37.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	34.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	56.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	51.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	56.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	62.0 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	59.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	53.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	39.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	57.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	65.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	63.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Double Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	42.9 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.p-value: 0.2195% CI: [0.91, 1.52]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.p-value: 0.00495% CI: [1.13, 1.89]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.p-value: <0.00195% CI: [1.23, 2.06]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of lncontinence episodes per 24 hours and baseline PPBC as covariates.p-value: <0.00195% CI: [1.23, 2.05]Logistic regression

Secondary

Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the HRQL total score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	15.2 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	24.9 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	33.3 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	33.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	42.0 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	36.9 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	20.6 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	39.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	44.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	45.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	38.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	30.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	28.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	49.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	43.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	49.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	54.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	51.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	46.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	32.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	46.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	54.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	52.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q HRQL Total Score and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	33.4 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.p-value: 0.41695% CI: [0.86, 1.43]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.p-value: 0.10595% CI: [0.96, 1.59]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.p-value: <0.00195% CI: [1.28, 2.16]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q HRQL total score and baseline PPBC as covariates.p-value: 0.00595% CI: [1.12, 1.87]Logistic regression

Secondary

Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT

The percentage of participants considered as triple responders, defined as participants with 50% reduction in mean number of incontinence episodes per 24 hours compared to baseline, minimal important difference reached (improvement by ≥ 10 points) on the OAB-q Symptom Bother score, and ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	17.8 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	29.7 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	35.8 percentage of participants
Placebo	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	36.1 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	47.7 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	41.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	24.0 percentage of participants
Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	45.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	48.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	49.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	43.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	33.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	31.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	53.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	47.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	54.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	58.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	56.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	51.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	37.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 8	54.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 12	62.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	End of treatment	60.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, at Least 10 Points Improvement on OAB-q Symptom Bother Scale and at Least 1 Point Improvement on PPBC) at Weeks 4, 8, 12 and EoT	Week 4	40.2 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.p-value: 0.33595% CI: [0.88, 1.46]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.p-value: 0.00995% CI: [1.09, 1.81]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.p-value: 0.00195% CI: [1.21, 2.02]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors, and baseline mean number of incontinence episodes per 24 hours, baseline OAB-q symptom bother scale and baseline PPBC as covariates.p-value: <0.00195% CI: [1.33, 2.21]Logistic regression

Secondary

Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	45.3 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	51.2 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	57.7 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	56.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	62.4 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	62.2 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	52.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	61.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	68.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	69.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	65.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	59.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	61.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	71.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	66.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	71.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	76.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	74.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	71.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	62.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 8	69.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 12	71.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	End of treatment	71.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQL Total Score at Weeks 4, 8, 12 and EoT	Week 4	61.3 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.07795% CI: [0.97, 1.72]Logistic regression

Comparison: Odds ratio from a logistic regression model treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.32195% CI: [0.87, 1.53]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: <0.00195% CI: [1.46, 2.53]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.29495% CI: [0.88, 1.53]Logistic regression

Secondary

Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 10 points improvement from baseline to each visit (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	56.4 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	62.2 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	66.0 percentage of participants
Placebo	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	65.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	72.1 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	71.6 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	62.6 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	71.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	77.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	78.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	73.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	69.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	73.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	81.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	79.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	82.4 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	83.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	82.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	83.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	73.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 8	82.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 12	85.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	End of treatment	84.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Weeks 4, 8, 12 and EoT	Week 4	75.8 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.22495% CI: [0.88, 1.69]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.03795% CI: [1.02, 1.96]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: <0.00195% CI: [1.47, 2.67]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.00295% CI: [1.21, 2.26]Logistic regression

Secondary

Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 1 point improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	48.9 percentage of participants
Placebo	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	56.4 percentage of participants
Placebo	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	59.8 percentage of participants
Placebo	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	59.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	66.9 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	65.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	52.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	65.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	72.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	73.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	69.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	60.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	58.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	71.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	72.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	74.1 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	76.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	75.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	71.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	63.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	75.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	80.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treaetment	78.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	62.7 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: 0.06595% CI: [0.98, 1.78]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: 0.00195% CI: [1.24, 2.27]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.32, 2.36]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: 0.00795% CI: [1.12, 2.04]Logistic regression

Secondary

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT

The percentage of participants with ≥ 50% decrease from baseline in mean number of incontinence episodes per 24 hours at each time point (weeks 4, 8, 12 and EoT).

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	41.1 percentage of participants
Placebo	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	54.9 percentage of participants
Placebo	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	58.6 percentage of participants
Placebo	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	59.5 percentage of participants
Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	66.4 percentage of participants
Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	61.8 percentage of participants
Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	45.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	64.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	69.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	70.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	63.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	56.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	53.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	70.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	65.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	71.0 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	75.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	74.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	69.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	57.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 8	70.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 12	76.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	End of treatment	75.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Weeks 4, 8, 12 and EoT	Week 4	60.6 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.25195% CI: [0.89, 1.53]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.10795% CI: [0.95, 1.64]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: <0.00195% CI: [1.23, 2.07]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.01295% CI: [1.08, 1.85]Logistic regression

Secondary

Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT

The percentage of participants with a major (≥ 2 points) improvement from baseline in PPBC at weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	15.9 percentage of participants
Placebo	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	27.0 percentage of participants
Placebo	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	29.6 percentage of participants
Placebo	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	29.5 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	39.0 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	33.3 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	20.6 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	37.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	40.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	42.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	35.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	22.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	27.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	42.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	40.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	44.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	50.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	49.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	42.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	31.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 8	46.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 12	52.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	End of treatment	51.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Weeks 4, 8, 12 and EoT	Week 4	31.1 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: 0.00795% CI: [1.11, 1.87]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.28, 2.17]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.34, 2.3]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.29, 2.19]Logistic regression

Secondary

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 3 days prior to weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	23.2 percentage of particpants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	28.7 percentage of particpants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	38.0 percentage of particpants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	37.6 percentage of particpants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	42.5 percentage of particpants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	35.3 percentage of particpants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	24.9 percentage of particpants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	40.6 percentage of particpants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	46.3 percentage of particpants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	47.4 percentage of particpants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	40.7 percentage of particpants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	27.6 percentage of particpants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	28.9 percentage of particpants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	42.9 percentage of particpants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	38.3 percentage of particpants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	42.7 percentage of particpants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	52.3 percentage of particpants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	50.7 percentage of particpants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	45.3 percentage of particpants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	35.1 percentage of particpants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	48.2 percentage of particpants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	52.7 percentage of particpants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	52.2 percentage of particpants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	37.3 percentage of particpants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.03595% CI: [1.02, 1.69]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.00995% CI: [1.09, 1.81]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.00295% CI: [1.16, 1.93]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours during the last 3 days as a covariate.p-value: 0.02395% CI: [1.04, 1.73]Logistic regression

Secondary

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT

The percentage of participants with zero incontinence episodes per 24 hours postbaseline in the last 7 days prior to weeks 4, 8, 12 and EoT.

Time frame: Weeks 4, 8, 12 and EoT (up to 12 weeks)

Population: FAS participants with available data at each time point were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	12.8 percentage of participants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	19.1 percentage of participants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	29.1 percentage of participants
Placebo	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	28.6 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	32.2 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	24.4 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	13.1 percentage of participants
Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	30.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	34.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	35.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	29.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	16.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	17.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	31.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	28.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	31.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	42.4 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	40.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	36.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	23.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 8	38.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 12	43.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	End of treatment	43.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Weeks 4, 8, 12 and EoT	Week 4	26.0 percentage of participants

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00495% CI: [1.13, 1.92]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: <0.00195% CI: [1.24, 2.11]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00195% CI: [1.22, 2.07]Logistic regression

Comparison: Odds ratio from a logistic regression model including treatment group, sex, age group (\<65, \>=65 years), previous OAB medication (yes, no) and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00195% CI: [1.21, 2.04]Logistic regression

Secondary

PGIC Scale: Impression in General Health at Week 12 and EoT

Time frame: Week 12 and EoT (up to 12 weeks)

Population: FAS participants with available data were included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	24.4 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	4.3 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	4.3 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.2 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	1.9 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	31.8 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	24.2 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	4.8 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	23.9 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	32.3 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	4.8 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.5 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	1.7 percentage of participants
Placebo	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	23.9 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	8.0 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	8.0 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	28.0 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	28.0 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	21.5 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	21.5 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	0.7 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	27.8 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	2.9 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	2.9 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	0.7 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.7 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	28.3 percentage of participants
Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.5 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	22.4 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	27.7 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	1.2 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	22.9 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	1.2 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	7.3 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	27.5 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	2.4 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	29.2 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	7.3 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	29.2 percentage of participants
Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	2.2 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	31.8 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	7.7 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	31.8 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	24.1 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	25.3 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	1.4 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	0.5 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.5 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	7.7 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	24.1 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	26.5 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	1.9 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	0.5 percentage of participants
Solifenacin 5 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.7 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	2.8 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	10.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	24.3 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	20.1 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	20.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	33.4 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	2.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	33.6 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	23.9 percentage of participants
Solifenacin 5 mg + Mirabegron 25 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	10.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much worse	0.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much improved	14.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally improved	21.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much worse	0.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally worse	2.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment:No change	21.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: No change	21.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Very much worse	0.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Minimally worse	2.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Minimally improved	20.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	Week 12: Much improved	30.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Very much improved	14.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much worse	0.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	PGIC Scale: Impression in General Health at Week 12 and EoT	End of treatment: Much improved	30.4 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder

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Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours

Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours

Change From Baseline to EoT in Corrected Micturition Frequency

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-Care

Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities

Change From Baseline to EoT in European Quality of Life in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility

Change From Baseline to EoT in Mean Volume Voided Per Micturition

Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score

Change From Baseline to EoT in Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

Change From Baseline to Week 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Activity Impairment

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

Change From Baseline to Week 12 and EoT in WPAI:SHP Score: Percent Overall Work Impairment

Change From Baseline to Weeks 4, 12 and EoT in DBP Peak/Trough Difference

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP)

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-h, Mean Daytime and Mean Nighttime Pulse Rate (PR)

Change From Baseline to Weeks 4, 12 and EoT in Mean 24-hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP)

Change From Baseline to Weeks 4, 12 and EoT in Mean DBP in the Tmax Window

Change From Baseline to Weeks 4, 12 and EoT in Mean PR in the Tmax Window

Change From Baseline to Weeks 4, 12 and EoT in Mean SBP in the Time to Maximum Concentration (Tmax) Window

Change From Baseline to Weeks 4, 12 and EoT in PR Peak/Trough Difference

Change From Baseline to Weeks 4, 12 and EoT in SBP Peak/Trough Difference

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Pads Used Per 24 Hours

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

Change From Baseline to Weeks 4, 8, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Incontinence Episodes

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Nocturia Episodes

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Pads Used

Change From Baseline to Weeks 4, 8, 12 and EoT in Number of Urgency Incontinence Episodes

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q Health-Related Quality of Life Questionnaire (HRQL) Total Score

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Concern

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Coping

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Sleep

Change From Baseline to Weeks 4, 8, 12 and EoT in OAB-q HRQL Subscale Score: Social

Change From Baseline to Weeks 4, 8, 12 and EoT in Patient Perception of Bladder Condition Questionnaire (PPBC)

Change From Baseline to Weeks 4, 8, 12 and EoT in Postvoid Residual (PVR) Volume

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

Change From Baseline to Weeks 4, 8 and 12 in Mean Number of Micturitions Per 24 Hours

Change From Baseline to Weeks 4, 8 and 12 in Mean Volume Voided Per Micturition

Change From Baseline to Weeks 4, 8 and 12 in the OAB-q Symptom Bother Score

Change From Baseline to Weeks 4, 8 and 12 in TS-VAS

Maximum 1-hour Change From Time-matched Baseline in DBP at Weeks 4, 12 and EoT

Maximum 1-hour Change From Time-matched Baseline in PR at Weeks 4, 12 and EoT

Maximum 1-hour Change From Time-matched Baseline in SBP at Weeks 4, 12 and EoT

Number of Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

Number of Incontinence Episodes at Weeks 4, 8, 12 and EoT

Number of Incontinence-Free Days at Weeks 4, 8, 12 and EoT

Number of Incontinence-Free Days With < 8 Micturitions at Weeks 4, 8, 12 and EoT

Number of Nocturia Episodes at Weeks 4, 8, 12 and EoT

Number of Pads Used at Weeks 4, 8, 12 and EoT

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Number of Urgency Incontinence Episodes at Weeks 4, 8, 12 and EoT

Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Week 12 and EoT

Percentage of Participants for Micturition Frequency Normalization at Weeks 4, 8, 12 and EoT