A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Multi-center Study to Evaluate the Long-Term Safety and Efficacy of Combination of Solifenacin Succinate With Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in Subjects With Overactive Bladder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02045862

Acronym

SYNERGY II

Enrollment

1829

Registered

2014-01-27

Start date

2014-03-17

Completion date

2016-09-08

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

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

Brief summary

The purpose of this study was to examine how well the combination of two medicines (solifenacin succinate and mirabegron) worked compared to each medicine alone in the treatment of bladder problems, and how safe they were for long term use.

Interventions

DRUGSolifenacin succinate

Participants received solifenacin 5 mg orally once a day at the same time each day.

DRUGMirabegron

Participants received mirabegron 50 mg orally once a day at the same time each day.

DRUGPlacebo to match solifenacin

Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

DRUGPlacebo to match mirabegron

Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion at Screening (Visit 1): * Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterion would no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012 had been completed. In that case the subject had to have symptoms of wet OAB (urinary frequency and urgency with incontinence) for at least 3 months); * 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; Main Inclusion at Randomization (Visit 2): * Subject had a micturition frequency of on average ≥ 8 times per 24-hour period during the last 7 days of the micturition diary period (incontinence episode should not be counted as a micturition). * Subject had experienced at least 3 incontinence episodes during the last 7 days of the micturition diary period. * Subject had experienced on average at least 1 urgency episode (grade 3 or 4 on Patient Perception of Intensity of Urgency Scale \[PPIUS\]) per 24-hour period during the 7-day micturition diary period.

Exclusion criteria

Main Exclusion at Screening (Visit 1): * Subject had clinically significant bladder outflow obstruction at risk of urinary retention; * Subject had significant PVR volume (\> 150 mL); * Subject had significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor; * Subject has an indwelling catheter or practices intermittent self-catheterization; * Subject had evidence of a UTI (urine culture containing \> 100,000 cfu/mL), chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs; * Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin, resiniferatoxin, capsaicin; Main Exclusion at Randomization (Visit 2): * Subject had evidence of a urinary tract infection (UTI) (urine culture containing \> 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject could be rescreened after successful treatment of the UTI (confirmed by a dipstick negative for nitrite). * Subject had an average total daily urine volume \> 3000 mL as recorded in the micturition diary period.

Design outcomes

Primary

Measure	Time frame	Description
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 56 weeks)	A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and Week 52	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 in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	Baseline and Week 52	A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.

Secondary

Measure	Time frame	Description
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	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 in a micturition diary for 7 days prior to the baseline and prior to each visit.
Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Baseline and Months 1, 3, 6, 9, 12	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	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 Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Baseline and Months 1, 3, 6, 9, 12	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 total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Months 1, 3, 6, 9, 12	The number of days with \< 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
Change From Baseline to EoT in Corrected Micturition Frequency	Baseline and Month 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. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Baseline and Months 3, 6, 12	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 prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	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 goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Baseline and Months 1, 3, 6, 9, 12	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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Baseline and Months 1, 3, 6, 9, 12	The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Months 1, 3, 6, 9, 12	The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Baseline and Months 1, 3, 6, 9, 12	The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists 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 Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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 Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Baseline and Months 1, 3, 6, 9, 12	The TS-VAS is a visual analogue scale which asks 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.
Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Baseline and Months 1, 3, 6, 9, 12	The PPBC is 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.
Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12	The PGIC is 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).
Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12	The PGIC is 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).
Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Baseline and 12 Months	The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Baseline and Month 12	The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Baseline and Month 12	The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Baseline and Month 12	The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Baseline and Month 12	The EQ-5D questionnaire is an international, standardized, nondisease specific instrument for describing and valuing health status, and had 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Baseline and Months 6,12	The WPAI:SHP is 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 are 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 Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Baseline and Months 6, 12	The WPAI:SHP is 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 are 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 Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Baseline and Months 6, 12	The WPAI:SHP is 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 arre 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 Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Baseline and Months 6, 12	The WPAI:SHP is 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 are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. A negative change from baseline indicated improvement.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Months 1, 3, 6, 9, 12	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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.
Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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.
Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	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 in a micturition diary for 7 days prior to each visit.
Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Months 1, 3, 6, 9, 12	An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.
Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.
Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The PPBC is 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.
Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The PPBC is 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.
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 Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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 EoT in Mean Volume Voided Per Micturition	Baseline and Week 52	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.
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 Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	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 in a micturition diary for 7 days prior to each visit. The PPBC is 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.
Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists 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.The PPBC is 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.
Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total 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.The PPBC is 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 Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Baseline and Months 1, 3, 6, 9, 12	PVR volume was assessed by ultrasonography or a bladder scanner.
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 Months 1, 3, 6, 9, 12 and EoT	Baseline and Months 1, 3, 6, 9, 12	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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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 EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	Baseline and Week 52	The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists 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 EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	Baseline and Week 52	The TS-VAS is a visual analogue scale which asks 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.

Countries

Australia, Belgium, Bulgaria, Canada, Czechia, Denmark, Estonia, Finland, Germany, Hungary, Italy, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Thailand, Ukraine, United Kingdom, United States

Participant flow

Recruitment details

Participants who had symptoms of wet overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 (NCT01972841) or 905-EC-012 (NCT01908829).

Pre-assignment details

A total of 2084 participants were screened, 2063 participants received placebo run-in treatment and 1829 participants were randomized into 1 of 3 treatment arms in a 1:1:4 ratio in the 52-week double-blind treatment period. Randomization was stratified by sex, age group (\< 65 years, ≥ 65 years) and geographic region.

Participants by arm

Arm	Count
Mirabegron 50 mg Participants received mirabegron 50 mg once a day for 52 weeks.	306
Solifenacin 5 mg Participants received solifenacin 5 mg once a day for 52 weeks.	305
Solifenacin 5 mg + Mirabegron 50 mg Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.	1,218
Total	1,829

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Adverse Event	7	5	27
Overall Study	Death	0	0	1
Overall Study	Lack of Efficacy	8	4	13
Overall Study	Lost to Follow-up	1	2	6
Overall Study	Miscellaneous	5	0	8
Overall Study	Protocol Violation	0	0	6
Overall Study	Randomized but not Received Study Drug	0	2	8
Overall Study	Withdrawal by Patient	18	27	57

Baseline characteristics

Characteristic	Mirabegron 50 mg	Solifenacin 5 mg	Solifenacin 5 mg + Mirabegron 50 mg	Total
Age, Continuous	58.8 years STANDARD_DEVIATION 12.7	59.0 years STANDARD_DEVIATION 13.3	58.3 years STANDARD_DEVIATION 13	58.5 years STANDARD_DEVIATION 13
Mean Number of Incontinence Episodes per 24 Hours	3.15 incontinence episodes/24 hours STANDARD_DEVIATION 3.56	3.10 incontinence episodes/24 hours STANDARD_DEVIATION 3.58	3.04 incontinence episodes/24 hours STANDARD_DEVIATION 3.17	3.07 incontinence episodes/24 hours STANDARD_DEVIATION 3.31
Mean Number of Micturitions per 24 Hours	10.51 micturitions/24 hours STANDARD_DEVIATION 2.41	10.76 micturitions/24 hours STANDARD_DEVIATION 2.83	10.55 micturitions/24 hours STANDARD_DEVIATION 2.73	10.58 micturitions/24 hours STANDARD_DEVIATION 2.7
Mean Number of Nocturia Episodes per 24 Hours	1.48 nocturia episodes/24 hours STANDARD_DEVIATION 0.95	1.58 nocturia episodes/24 hours STANDARD_DEVIATION 0.94	1.49 nocturia episodes/24 hours STANDARD_DEVIATION 0.94	1.51 nocturia episodes/24 hours STANDARD_DEVIATION 0.94
Mean Number of Pads Used per 24 Hours	2.51 pads/24 hours STANDARD_DEVIATION 3.76	2.77 pads/24 hours STANDARD_DEVIATION 3.15	2.58 pads/24 hours STANDARD_DEVIATION 2.59	2.60 pads/24 hours STANDARD_DEVIATION 2.91
Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours	6.34 urgency episodes/24 hours STANDARD_DEVIATION 4.16	6.63 urgency episodes/24 hours STANDARD_DEVIATION 4.08	6.53 urgency episodes/24 hours STANDARD_DEVIATION 3.69	6.51 urgency episodes/24 hours STANDARD_DEVIATION 3.84
Mean Number of Urgency Incontinence Episodes per 24 Hours	2.86 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3.29	2.91 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3.49	2.74 urgency incontinence episodes/24 hours STANDARD_DEVIATION 2.78	2.79 urgency incontinence episodes/24 hours STANDARD_DEVIATION 3
Mean Volume Voided per Micturition	161.00 mL STANDARD_DEVIATION 60.16	160.70 mL STANDARD_DEVIATION 58.49	159.29 mL STANDARD_DEVIATION 58.4	159.82 mL STANDARD_DEVIATION 58.69
Number of Incontinence Episodes per Week	21.8 incontinence episodes/week STANDARD_DEVIATION 24.8	21.6 incontinence episodes/week STANDARD_DEVIATION 25	20.9 incontinence episodes/week STANDARD_DEVIATION 21.9	21.2 incontinence episodes/week STANDARD_DEVIATION 22.9
Number of Nocturia Episodes per Week	10.3 nocturia episodes/week STANDARD_DEVIATION 6.6	11.0 nocturia episodes/week STANDARD_DEVIATION 6.6	10.4 nocturia episodes/week STANDARD_DEVIATION 6.5	10.4 nocturia episodes/week STANDARD_DEVIATION 6.5
Number of Pads Used per Week	17.3 pads/week STANDARD_DEVIATION 26.1	19.2 pads/week STANDARD_DEVIATION 22	17.7 pads/week STANDARD_DEVIATION 17.6	17.9 pads/week STANDARD_DEVIATION 20
Number of Urgency Incontinence Episodes per Week	19.8 urgency incontinence episodes/week STANDARD_DEVIATION 22.8	20.2 urgency incontinence episodes/week STANDARD_DEVIATION 24.5	18.9 urgency incontinence episodes/week STANDARD_DEVIATION 19.1	19.3 urgency incontinence episodes/week STANDARD_DEVIATION 20.7
Race/Ethnicity, Customized Asian	31 Participants	33 Participants	119 Participants	183 Participants
Race/Ethnicity, Customized Black or African American	5 Participants	4 Participants	27 Participants	36 Participants
Race/Ethnicity, Customized Hispanic or Latino	15 Participants	15 Participants	54 Participants	84 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	291 Participants	290 Participants	1164 Participants	1745 Participants
Race/Ethnicity, Customized Other	4 Participants	3 Participants	6 Participants	13 Participants
Race/Ethnicity, Customized White	266 Participants	265 Participants	1066 Participants	1597 Participants
Sex: Female, Male Female	243 Participants	245 Participants	973 Participants	1461 Participants
Sex: Female, Male Male	63 Participants	60 Participants	245 Participants	368 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	1 / 305	0 / 303	1 / 1,206
other Total, other adverse events	27 / 305	33 / 303	115 / 1,206
serious Total, serious adverse events	8 / 305	8 / 303	51 / 1,206

Outcome results

Primary

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

Time frame: Baseline and Week 52

Population: FAS population; Last observation carried forward (LOCF) was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.58 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.90 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-2.03 incontinence episodes	Standard Error 0.05

Comparison: Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron 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 study history and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.69, -0.21]Stratified Rank ANCOVA

Comparison: Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin 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 study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00295% CI: [-0.37, 0.11]Stratified Rank ANCOVA

Primary

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

A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.

Time frame: Baseline and Week 52

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.10 micturitions	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.16 micturitions	Standard Error 0.13
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours	-2.58 micturitions	Standard Error 0.07

Primary

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

A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).

Time frame: From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)

Population: The analysis population was the safety analysis set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAEs	126 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Mild TEAEs	61 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Moderate TEAEs	52 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Severe TEAEs	13 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	35 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	8 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 Discontuation of Study Drug	7 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs Leading to Discont. of Drug	4 Participants
Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs Leading to Death	0 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs Leading to Discont. of Drug	4 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAEs	134 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	8 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	42 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Mild TEAEs	69 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs Leading to Death	0 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs Leading to Discontuation of Study Drug	5 Participants
Solifenacin 5 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Moderate TEAEs	58 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)	Severe TEAEs	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs Leading to Discontuation of Study Drug	25 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Severe TEAEs	52 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs	200 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Serious TEAEs	51 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related TEAEs Leading to Discont. of Drug	17 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Drug-related Serious TEAEs	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Any TEAEs	596 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	TEAEs Leading to Death	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Mild TEAEs	306 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Moderate TEAEs	238 Participants

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. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.

Time frame: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-0.72 micturitions	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-1.11 micturitions	Standard Error 0.17
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Corrected Micturition Frequency	-1.51 micturitions	Standard Error 0.08

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: <0.00195% CI: [-1.16, -0.41]ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.03795% CI: [-0.77, -0.02]ANCOVA

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 Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	21.83 mL	Standard Error 3.12
Solifenacin 5 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	24.90 mL	Standard Error 3.1
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Mean Volume Voided Per Micturition	37.67 mL	Standard Error 1.55

Secondary

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

The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists 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 Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-21.96 units on a scale	Standard Error 1.14
Solifenacin 5 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-24.91 units on a scale	Standard Error 1.13
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score	-29.51 units on a scale	Standard Error 0.57

Secondary

Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

The TS-VAS is a visual analogue scale which asks 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 Week 52

Population: FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.19 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.15 units on a scale	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)	2.73 units on a scale	Standard Error 0.06

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 1	11.67 units on a scale	Standard Error 0.92
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 3	15.25 units on a scale	Standard Error 0.95
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 6	16.63 units on a scale	Standard Error 1.02
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 9	16.69 units on a scale	Standard Error 1.02
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 12	17.33 units on a scale	Standard Error 1.04
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	EoT	16.57 units on a scale	Standard Error 1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	EoT	18.47 units on a scale	Standard Error 0.99
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 1	14.01 units on a scale	Standard Error 0.91
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 9	18.53 units on a scale	Standard Error 1.01
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 12	18.80 units on a scale	Standard Error 1.03
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 3	16.41 units on a scale	Standard Error 0.94
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 6	17.96 units on a scale	Standard Error 1
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 3	19.26 units on a scale	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 6	20.03 units on a scale	Standard Error 0.49
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	EoT	21.33 units on a scale	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 9	20.75 units on a scale	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 1	15.69 units on a scale	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score	Month 12	21.82 units on a scale	Standard Error 0.51

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [2.56, 6.96]ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.0195% CI: [0.68, 5.04]ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 1	7.99 units on a scale	Standard Error 0.84
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 3	11.14 units on a scale	Standard Error 0.85
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 6	11.89 units on a scale	Standard Error 0.89
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 9	11.92 units on a scale	Standard Error 0.9
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 12	12.25 units on a scale	Standard Error 0.9
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	EoT	11.57 units on a scale	Standard Error 0.87
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	EoT	13.22 units on a scale	Standard Error 0.87
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 1	9.41 units on a scale	Standard Error 0.83
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 9	13.33 units on a scale	Standard Error 0.89
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 12	13.47 units on a scale	Standard Error 0.89
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 3	11.19 units on a scale	Standard Error 0.84
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 6	12.54 units on a scale	Standard Error 0.87
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 3	12.22 units on a scale	Standard Error 0.42
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 6	13.30 units on a scale	Standard Error 0.43
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	EoT	14.25 units on a scale	Standard Error 0.43
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 9	13.64 units on a scale	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 1	9.89 units on a scale	Standard Error 0.42
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social	Month 12	14.52 units on a scale	Standard Error 0.44

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 1	13.24 units on a scale	Standard Error 1.03
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 3	16.37 units on a scale	Standard Error 1.05
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 6	17.77 units on a scale	Standard Error 1.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 9	18.15 units on a scale	Standard Error 1.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 12	19.10 units on a scale	Standard Error 1.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	EoT	17.98 units on a scale	Standard Error 1.08
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	EoT	19.22 units on a scale	Standard Error 1.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 1	15.49 units on a scale	Standard Error 1.02
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 9	19.74 units on a scale	Standard Error 1.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 12	19.40 units on a scale	Standard Error 1.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 3	17.64 units on a scale	Standard Error 1.04
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 6	19.05 units on a scale	Standard Error 1.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 3	21.23 units on a scale	Standard Error 0.52
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 6	21.73 units on a scale	Standard Error 0.53
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	EoT	23.00 units on a scale	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 9	22.30 units on a scale	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 1	17.60 units on a scale	Standard Error 0.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern	Month 12	23.30 units on a scale	Standard Error 0.54

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 1	13.05 units on a scale	Standard Error 1.09
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 3	17.57 units on a scale	Standard Error 1.14
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 6	19.68 units on a scale	Standard Error 1.22
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 9	19.54 units on a scale	Standard Error 1.21
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 12	19.47 units on a scale	Standard Error 1.25
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	EoT	18.54 units on a scale	Standard Error 1.19
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	EoT	21.13 units on a scale	Standard Error 1.18
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 1	15.40 units on a scale	Standard Error 1.08
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 9	21.21 units on a scale	Standard Error 1.2
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 12	21.90 units on a scale	Standard Error 1.23
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 3	18.38 units on a scale	Standard Error 1.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 6	20.53 units on a scale	Standard Error 1.19
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 3	21.64 units on a scale	Standard Error 0.56
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 6	22.73 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	EoT	24.14 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 9	23.58 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 1	17.58 units on a scale	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping	Month 12	24.86 units on a scale	Standard Error 0.61

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 1	10.96 units on a scale	Standard Error 1.08
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 3	14.09 units on a scale	Standard Error 1.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 6	14.84 units on a scale	Standard Error 1.22
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 9	14.86 units on a scale	Standard Error 1.22
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 12	16.53 units on a scale	Standard Error 1.29
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	EoT	16.44 units on a scale	Standard Error 1.22
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	EoT	18.32 units on a scale	Standard Error 1.21
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 1	14.24 units on a scale	Standard Error 1.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 9	17.73 units on a scale	Standard Error 1.21
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 12	18.28 units on a scale	Standard Error 1.27
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 3	16.71 units on a scale	Standard Error 1.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 6	17.70 units on a scale	Standard Error 1.19
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 3	19.75 units on a scale	Standard Error 0.55
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 6	20.09 units on a scale	Standard Error 0.59
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	EoT	21.59 units on a scale	Standard Error 0.61
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 9	21.15 units on a scale	Standard Error 0.6
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 1	15.82 units on a scale	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep	Month 12	22.17 units on a scale	Standard Error 0.63

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

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 goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.

Time frame: Baseline and Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 1	-0.20 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 3	-0.34 nocturia episodes	Standard Error 0.04
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 6	-0.41 nocturia episodes	Standard Error 0.05
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 9	-0.42 nocturia episodes	Standard Error 0.05
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 12	-0.46 nocturia episodes	Standard Error 0.05
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	EoT	-0.45 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	EoT	-0.45 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 1	-0.22 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 9	-0.44 nocturia episodes	Standard Error 0.05
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 12	-0.44 nocturia episodes	Standard Error 0.05
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 3	-0.38 nocturia episodes	Standard Error 0.04
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 6	-0.39 nocturia episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 3	-0.46 nocturia episodes	Standard Error 0.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 6	-0.49 nocturia episodes	Standard Error 0.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	EoT	-0.55 nocturia episodes	Standard Error 0.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 9	-0.50 nocturia episodes	Standard Error 0.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 1	-0.34 nocturia episodes	Standard Error 0.02
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours	Month 12	-0.56 nocturia episodes	Standard Error 0.02

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.05995% CI: [-0.19, 0]ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.06895% CI: [-0.19, 0.01]ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 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 in the micturition diary for 7 days prior to each visit.

Time frame: Baseline and Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 1	-0.67 pads	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 3	-1.12 pads	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 6	-1.30 pads	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 9	-1.38 pads	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 12	-1.35 pads	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	EoT	-1.23 pads	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	EoT	-1.38 pads	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 1	-0.96 pads	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 9	-1.31 pads	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 12	-1.37 pads	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 3	-1.30 pads	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 6	-1.24 pads	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 3	-1.49 pads	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 6	-1.59 pads	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	EoT	-1.66 pads	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 9	-1.65 pads	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 1	-1.25 pads	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours	Month 12	-1.67 pads	Standard Error 0.06

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.

Time frame: Baseline and Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 1	-1.93 urgency episodes	Standard Error 0.17
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 3	-2.68 urgency episodes	Standard Error 0.17
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 6	-2.93 urgency episodes	Standard Error 0.17
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 9	-3.40 urgency episodes	Standard Error 0.18
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 12	-3.40 urgency episodes	Standard Error 0.17
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	EoT	-3.11 urgency episodes	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	EoT	-3.45 urgency episodes	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 1	-2.31 urgency episodes	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 9	-3.55 urgency episodes	Standard Error 0.18
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 12	-3.56 urgency episodes	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 3	-3.02 urgency episodes	Standard Error 0.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 6	-3.17 urgency episodes	Standard Error 0.17
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 3	-3.36 urgency episodes	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 6	-3.72 urgency episodes	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	EoT	-3.84 urgency episodes	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 9	-3.87 urgency episodes	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 1	-2.68 urgency episodes	Standard Error 0.09
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours	Month 12	-3.95 urgency episodes	Standard Error 0.09

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-1.1, -0.37]ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.03695% CI: [-0.76, -0.03]ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. 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
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 1	-0.93 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 3	-1.30 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 6	-1.40 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 9	-1.60 urgency incontinence episodes	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 12	-1.60 urgency incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	EoT	-1.51 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	EoT	-1.81 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 1	-1.25 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 9	-1.78 urgency incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 12	-1.82 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 3	-1.64 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 6	-1.67 urgency incontinence episodes	Standard Error 0.1
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 3	-1.71 urgency incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 6	-1.86 urgency incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	EoT	-1.94 urgency incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 9	-1.92 urgency incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 1	-1.43 urgency incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Month 12	-1.98 urgency incontinence episodes	Standard Error 0.05

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-0.65, -0.21]Stratified Rank ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariatep-value: 0.00995% CI: [-0.36, 0.09]Stratified Rank ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-6.77 incontinence episodes	Standard Error 0.73
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-9.21 incontinence episodes	Standard Error 0.76
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-10.36 incontinence episodes	Standard Error 0.76
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-10.62 incontinence episodes	Standard Error 0.76
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-11.84 incontinence episodes	Standard Error 0.77
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-11.17 incontinence episodes	Standard Error 0.75
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-13.37 incontinence episodes	Standard Error 0.75
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-9.17 incontinence episodes	Standard Error 0.73
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-13.51 incontinence episodes	Standard Error 0.77
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-13.47 incontinence episodes	Standard Error 0.77
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-12.05 incontinence episodes	Standard Error 0.75
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-12.50 incontinence episodes	Standard Error 0.75
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-12.55 incontinence episodes	Standard Error 0.38
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-13.49 incontinence episodes	Standard Error 0.37
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-14.29 incontinence episodes	Standard Error 0.37
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-14.06 incontinence episodes	Standard Error 0.38
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-10.31 incontinence episodes	Standard Error 0.36
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-14.43 incontinence episodes	Standard Error 0.38

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit

Time frame: Baseline and Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-1.56 nocturia episodes	Standard Error 0.29
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-2.45 nocturia episodes	Standard Error 0.29
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-3.08 nocturia episodes	Standard Error 0.33
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-2.91 nocturia episodes	Standard Error 0.32
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-3.29 nocturia episodes	Standard Error 0.32
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-3.24 nocturia episodes	Standard Error 0.31
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-3.20 nocturia episodes	Standard Error 0.32
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-1.58 nocturia episodes	Standard Error 0.29
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-3.13 nocturia episodes	Standard Error 0.32
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-3.08 nocturia episodes	Standard Error 0.33
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-2.78 nocturia episodes	Standard Error 0.3
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-2.81 nocturia episodes	Standard Error 0.33
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-3.26 nocturia episodes	Standard Error 0.15
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-3.44 nocturia episodes	Standard Error 0.16
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-3.90 nocturia episodes	Standard Error 0.16
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-3.55 nocturia episodes	Standard Error 0.16
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-2.39 nocturia episodes	Standard Error 0.15
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-3.97 nocturia episodes	Standard Error 0.16

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.05595% CI: [-1.34, 0.01]ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.04895% CI: [-1.39, -0.01]ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

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

Time frame: Baseline and Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-4.74 pads	Standard Error 0.71
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-7.83 pads	Standard Error 0.77
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-9.09 pads	Standard Error 0.85
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-9.59 pads	Standard Error 0.87
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-9.39 pads	Standard Error 0.85
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-8.59 pads	Standard Error 0.82
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-9.89 pads	Standard Error 0.84
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-6.72 pads	Standard Error 0.72
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-9.33 pads	Standard Error 0.89
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-9.92 pads	Standard Error 0.87
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-9.21 pads	Standard Error 0.78
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-8.86 pads	Standard Error 0.85
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	10.47 pads	Standard Error 0.39
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-11.12 pads	Standard Error 0.42
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-11.58 pads	Standard Error 0.42
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-11.44 pads	Standard Error 0.43
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-8.89 pads	Standard Error 0.36
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-11.66 pads	Standard Error 0.42

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

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 total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. 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
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-6.45 urgency incontinence episodes	Standard Error 0.69
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-9.06 urgency incontinence episodes	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-10.09 urgency incontinence episodes	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-11.1 urgency incontinence episodes	Standard Error 0.72
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-11.27 urgency incontinence episodes	Standard Error 0.71
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-10.61 urgency incontinence episodes	Standard Error 0.7
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	12.66 urgency incontinence episodes	Standard Error 0.7
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-8.77 urgency incontinence episodes	Standard Error 0.69
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-12.6 urgency incontinence episodes	Standard Error 0.73
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-12.8 urgency incontinence episodes	Standard Error 0.71
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-11.48 urgency incontinence episodes	Standard Error 0.71
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-11.71 urgency incontinence episodes	Standard Error 0.71
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	-11.99 urgency incontinence episodes	Standard Error 0.36
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	-13.0 urgency incontinence episodes	Standard Error 0.35
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	-13.59 urgency incontinence episodes	Standard Error 0.35
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	-13.44 urgency incontinence episodes	Standard Error 0.36
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	-10.1 urgency incontinence episodes	Standard Error 0.34
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	-13.8 urgency incontinence episodes	Standard Error 0.35

Comparison: Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: <0.00195% CI: [-4.51, -1.46]Stratified Rank ANCOVA

Comparison: Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.p-value: 0.00695% CI: [-2.47, 0.61]Stratified Rank ANCOVA

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)

The PPBC is 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 1	-0.84 units on a scale	Standard Error 0.07
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 3	-1.09 units on a scale	Standard Error 0.07
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 6	-1.11 units on a scale	Standard Error 0.07
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 9	-1.25 units on a scale	Standard Error 0.07
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 12	-1.29 units on a scale	Standard Error 0.08
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	EoT	-1.22 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	EoT	-1.34 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 1	-0.89 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 9	-1.31 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 12	-1.36 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 3	-1.08 units on a scale	Standard Error 0.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 6	-1.18 units on a scale	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 3	-1.33 units on a scale	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 6	-1.42 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	EoT	-1.54 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 9	-1.48 units on a scale	Standard Error 0.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 1	-1.05 units on a scale	Standard Error 0.03
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)	Month 12	-1.59 units on a scale	Standard Error 0.04

Secondary

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume

PVR volume was assessed by ultrasonography or a bladder scanner.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: SAF population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 1	3.179 mL	Standard Deviation 27.491
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 3	4.686 mL	Standard Deviation 29.354
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 6	1.596 mL	Standard Deviation 29.399
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 9	3.074 mL	Standard Deviation 32.897
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 12	2.002 mL	Standard Deviation 32.453
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	EoT	1.747 mL	Standard Deviation 32.4
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	EoT	7.382 mL	Standard Deviation 42.916
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 1	4.549 mL	Standard Deviation 33.973
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 9	3.436 mL	Standard Deviation 32.17
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 12	4.818 mL	Standard Deviation 33.764
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 3	3.233 mL	Standard Deviation 32.679
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 6	3.418 mL	Standard Deviation 31.864
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 3	7.033 mL	Standard Deviation 37.328
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 6	6.708 mL	Standard Deviation 35.881
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	EoT	8.522 mL	Standard Deviation 39.501
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 9	8.229 mL	Standard Deviation 40.313
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 1	7.894 mL	Standard Deviation 38.369
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume	Month 12	7.946 mL	Standard Deviation 38.118

Secondary

Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 9	-1.53 incontinence episodes	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 6	-1.42 incontinence episodes	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 1	-0.97 incontinence episodes	Standard Error 0.1
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 3	-1.31 incontinence episodes	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 12	-1.67 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 6	-1.78 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 1	-1.29 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 3	-1.71 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 9	-1.90 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 12	-1.92 incontinence episodes	Standard Error 0.11
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 12	-2.06 incontinence episodes	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 9	-2.00 incontinence episodes	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 1	-1.45 incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 6	-1.93 incontinence episodes	Standard Error 0.05
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours	Month 3	-1.78 incontinence episodes	Standard Error 0.05

Secondary

Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 9	-2.03 micturitions	Standard Error 0.13
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 6	-1.85 micturitions	Standard Error 0.13
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 1	-1.09 micturitions	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 3	-1.63 micturitions	Standard Error 0.13
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 12	-2.20 micturitions	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 6	-2.04 micturitions	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 1	-1.36 micturitions	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 3	-1.87 micturitions	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 9	-2.03 micturitions	Standard Error 0.13
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 12	-2.13 micturitions	Standard Error 0.14
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 12	-2.64 micturitions	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 9	-2.42 micturitions	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 1	-1.64 micturitions	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 6	-2.39 micturitions	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours	Month 3	2.16 micturitions	Standard Error 0.06

Secondary

Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 9	-21.41 units on a scale	Standard Error 1.15
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 6	-20.97 units on a scale	Standard Error 1.14
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 1	-16.37 units on a scale	Standard Error 1.08
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 3	-19.69 units on a scale	Standard Error 1.08
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 12	-23.41 units on a scale	Standard Error 1.19
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 6	-24.27 units on a scale	Standard Error 1.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 1	-20.82 units on a scale	Standard Error 1.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 3	-23.13 units on a scale	Standard Error 1.07
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 9	-25.82 units on a scale	Standard Error 1.14
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 12	-25.38 units on a scale	Standard Error 1.18
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 12	-30.18 units on a scale	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 9	-28.45 units on a scale	Standard Error 0.56
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 1	-22.86 units on a scale	Standard Error 0.54
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 6	-27.73 units on a scale	Standard Error 0.55
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score	Month 3	-26.88 units on a scale	Standard Error 0.53

Secondary

Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 9	2.24 units on a scale	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 6	2.22 units on a scale	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 1	1.88 units on a scale	Standard Error 0.12
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 3	2.10 units on a scale	Standard Error 0.11
Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 12	2.33 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 6	2.25 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 1	1.95 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 3	2.06 units on a scale	Standard Error 0.11
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 9	2.28 units on a scale	Standard Error 0.12
Solifenacin 5 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 12	2.34 units on a scale	Standard Error 0.12
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 12	2.89 units on a scale	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 9	2.74 units on a scale	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 1	2.27 units on a scale	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 6	2.72 units on a scale	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS	Month 3	2.57 units on a scale	Standard Error 0.06

Secondary

Change From Baseline to Months 3, 6 and 12 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 prior to each visit.

Time frame: Baseline and Months 3, 6, 12

Population: FAS population with data available at each time point.

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 6	20.87 mL	Standard Error 3.21
Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 3	15.34 mL	Standard Error 2.96
Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 12	21.85 mL	Standard Error 3.42
Solifenacin 5 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 6	27.08 mL	Standard Error 3.19
Solifenacin 5 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 12	24.05 mL	Standard Error 3.37
Solifenacin 5 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 3	23.71 mL	Standard Error 2.92
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 6	38.56 mL	Standard Error 1.57
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 3	34.89 mL	Standard Error 1.45
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition	Month 12	38.72 mL	Standard Error 1.67

Secondary

Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

The WPAI:SHP is 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 are 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 Months 6,12

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 6	-0.49 percentage of work time missed	Standard Deviation 17.12
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	EoT	-0.45 percentage of work time missed	Standard Deviation 18.51
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 12	0.39 percentage of work time missed	Standard Deviation 15.55
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 6	-0.59 percentage of work time missed	Standard Deviation 15.67
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 12	-1.95 percentage of work time missed	Standard Deviation 18.51
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	EoT	-1.30 percentage of work time missed	Standard Deviation 18.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 6	-3.11 percentage of work time missed	Standard Deviation 20.68
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	EoT	-3.26 percentage of work time missed	Standard Deviation 22.88
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed	Month 12	-3.74 percentage of work time missed	Standard Deviation 23.83

Secondary

Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

Time frame: Baseline and Months 6, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 12	-19.16 percentage of impairment while working	Standard Deviation 23.38
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 6	-16.94 percentage of impairment while working	Standard Deviation 24.1
Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	EoT	-17.81 percentage of impairment while working	Standard Deviation 23.45
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 12	-14.72 percentage of impairment while working	Standard Deviation 27.32
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 6	-12.97 percentage of impairment while working	Standard Deviation 21.05
Solifenacin 5 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	EoT	-13.90 percentage of impairment while working	Standard Deviation 27.18
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 6	-13.41 percentage of impairment while working	Standard Deviation 24.37
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	EoT	-15.63 percentage of impairment while working	Standard Deviation 25.61
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working	Month 12	-16.68 percentage of impairment while working	Standard Deviation 24.16

Secondary

Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment

Time frame: Baseline and Months 6, 12

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 12	-16.85 percentage of activity Impairment	Standard Deviation 27.57
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 6	-15.04 percentage of activity Impairment	Standard Deviation 27.08
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	EoT	-16.02 percentage of activity Impairment	Standard Deviation 27.63
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 12	-14.12 percentage of activity Impairment	Standard Deviation 29.87
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 6	-16.25 percentage of activity Impairment	Standard Deviation 24.78
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	EoT	-14.02 percentage of activity Impairment	Standard Deviation 30.29
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 6	-16.94 percentage of activity Impairment	Standard Deviation 28.49
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	EoT	-18.75 percentage of activity Impairment	Standard Deviation 29.14
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment	Month 12	-18.91 percentage of activity Impairment	Standard Deviation 29.26

Secondary

Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment

The WPAI:SHP is 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 arre 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 Months 6, 12

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 12	-17.83 percentage of overall work impairment	Standard Deviation 26.9
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 6	-16.33 percentage of overall work impairment	Standard Deviation 27.58
Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	EoT	-16.83 percentage of overall work impairment	Standard Deviation 27.63
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 12	-15.38 percentage of overall work impairment	Standard Deviation 27.97
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 6	-12.09 percentage of overall work impairment	Standard Deviation 22.26
Solifenacin 5 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	EoT	-14.16 percentage of overall work impairment	Standard Deviation 27.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 6	-13.99 percentage of overall work impairment	Standard Deviation 26.04
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	EoT	-16.15 percentage of overall work impairment	Standard Deviation 28.51
Solifenacin 5 mg + Mirabegron 50 mg	Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment	Month 12	-17.27 percentage of overall work impairment	Standard Deviation 27.25

Secondary

Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 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 with less than 8 micturitions per day.

Time frame: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 1	1.90 days	Standard Error 0.13
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 3	2.07 days	Standard Error 0.14
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 6	2.35 days	Standard Error 0.15
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 9	2.38 days	Standard Error 0.16
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 12	2.61 days	Standard Error 0.16
Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	EoT	2.52 days	Standard Error 0.15
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	EoT	2.58 days	Standard Error 0.15
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 1	1.60 days	Standard Error 0.12
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 9	2.33 days	Standard Error 0.15
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 12	2.58 days	Standard Error 0.16
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 3	2.14 days	Standard Error 0.14
Solifenacin 5 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 6	2.34 days	Standard Error 0.15
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 3	2.66 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 6	2.87 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	EoT	3.10 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 9	2.93 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 1	2.08 days	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)	Month 12	3.17 days	Standard Error 0.08

Comparison: Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00295% CI: [1.14, 1.8]Overdispersed Binomial Regression

Comparison: Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00795% CI: [1.09, 1.73]Overdispersed Binomial Regression

Secondary

Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Time frame: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	14.88 incontinence episodes	Standard Error 1.52
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	12.23 incontinence episodes	Standard Error 1.12
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	10.62 incontinence episodes	Standard Error 1.08
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	10.53 incontinence episodes	Standard Error 1.19
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	9.09 incontinence episodes	Standard Error 1.1
Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	10.32 incontinence episodes	Standard Error 1.08
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	8.09 incontinence episodes	Standard Error 0.94
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	12.41 incontinence episodes	Standard Error 1.22
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	7.28 incontinence episodes	Standard Error 0.91
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	7.06 incontinence episodes	Standard Error 0.94
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	9.23 incontinence episodes	Standard Error 1.02
Solifenacin 5 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	8.18 incontinence episodes	Standard Error 1.01
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	8.33 incontinence episodes	Standard Error 0.52
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	7.28 incontinence episodes	Standard Error 0.48
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	6.85 incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	6.74 incontinence episodes	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	10.80 incontinence episodes	Standard Error 0.58
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	6.10 incontinence episodes	Standard Error 0.46

Comparison: Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.p-value: <0.00195% CI: [0.54, 0.84]Mixed Effects Poisson-Negative Binomial

Comparison: Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.p-value: 0.02995% CI: [0.61, 0.97]Mixed Effects Poisson-Negative Binomial

Secondary

Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit

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

Time frame: Months 1, 3, 6, 9, 12

Population: FAS population with with data available at each time point; LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	2.73 incontinence-free days	Standard Error 0.15
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	3.30 incontinence-free days	Standard Error 0.17
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	3.64 incontinence-free days	Standard Error 0.17
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	3.97 incontinence-free days	Standard Error 0.18
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	4.23 incontinence-free days	Standard Error 0.18
Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	3.98 incontinence-free days	Standard Error 0.17
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	4.29 incontinence-free days	Standard Error 0.16
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	3.35 incontinence-free days	Standard Error 0.17
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	4.33 incontinence-free days	Standard Error 0.17
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	4.5 incontinence-free days	Standard Error 0.18
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	3.98 incontinence-free days	Standard Error 0.17
Solifenacin 5 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	4.08 incontinence-free days	Standard Error 0.17
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	4.17 incontinence-free days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	4.44 incontinence-free days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	4.64 incontinence-free days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	4.56 incontinence-free days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	3.46 incontinence-free days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	4.81 incontinence-free days	Standard Error 0.08

Comparison: Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariatep-value: <0.00195% CI: [1.26, 2.01]Overdispersed Binomial Regression

Comparison: Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.00995% CI: [1.08, 1.75]Overdispersed Binomial Regression

Secondary

Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit

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: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point; LOCF was used for EoT.

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	1.03 days	Standard Error 0.1
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	1.24 days	Standard Error 0.12
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	1.56 days	Standard Error 0.14
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	1.56 days	Standard Error 0.14
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	1.87 days	Standard Error 0.15
Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	1.75 days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	1.90 days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	1.01 days	Standard Error 0.1
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	1.64 days	Standard Error 0.14
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	1.92 days	Standard Error 0.15
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	1.48 days	Standard Error 0.13
Solifenacin 5 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	1.66 days	Standard Error 0.14
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	1.91 days	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	2.13 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	2.43 days	Standard Error 0.07
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	2.20 days	Standard Error 0.08
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	1.33 days	Standard Error 0.06
Solifenacin 5 mg + Mirabegron 50 mg	Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	2.54 days	Standard Error 0.08

Comparison: Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.p-value: <0.00195% CI: [1.26, 2.05]Overdispersed Binomial Regression

Comparison: Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.p-value: 0.00295% CI: [1.14, 1.85]Overdispersed Binomial Regression

Secondary

Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

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 goes to bed with the intention to sleep until the time the participant gets 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 during the 7-day micturition diary period prior to each visit.

Time frame: Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	8.76 nocturia episodes	Standard Error 0.41
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	7.93 nocturia episodes	Standard Error 0.39
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	7.12 nocturia episodes	Standard Error 0.35
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	7.40 nocturia episodes	Standard Error 0.38
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	6.88 nocturia episodes	Standard Error 0.38
Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	7.13 nocturia episodes	Standard Error 0.37
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	7.47 nocturia episodes	Standard Error 0.42
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	9.23 nocturia episodes	Standard Error 0.44
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	7.48 nocturia episodes	Standard Error 0.41
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	7.39 nocturia episodes	Standard Error 0.44
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	7.92 nocturia episodes	Standard Error 0.4
Solifenacin 5 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	7.86 nocturia episodes	Standard Error 0.43
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	7.17 nocturia episodes	Standard Error 0.19
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	6.96 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	6.51 nocturia episodes	Standard Error 0.19
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	6.84 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	8.00 nocturia episodes	Standard Error 0.2
Solifenacin 5 mg + Mirabegron 50 mg	Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	6.33 nocturia episodes	Standard Error 0.19

Comparison: Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variablep-value: 0.06795% CI: [0.81, 1.01]Negative Binomial Regression

Comparison: Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.p-value: 0.13195% CI: [0.82, 1.03]Negative Binomial Regression

Secondary

Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

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

Time frame: Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	7.99 pads	Standard Error 1.03
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	9.09 pads	Standard Error 1.07
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	7.65 pads	Standard Error 1.08
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	9.61 pads	Standard Error 1.12
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	12.67 pads	Standard Error 1.98
Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	7.60 pads	Standard Error 1.05
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	12.55 pads	Standard Error 1.59
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	9.47 pads	Standard Error 1.28
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	9.16 pads	Standard Error 1.28
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	8.91 pads	Standard Error 1.28
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	8.09 pads	Standard Error 1.23
Solifenacin 5 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	8.54 pads	Standard Error 1.1
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	7.23 pads	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	6.33 pads	Standard Error 0.45
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	5.70 pads	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	6.51 pads	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	8.75 pads	Standard Error 0.5
Solifenacin 5 mg + Mirabegron 50 mg	Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	6.18 pads	Standard Error 0.46

Comparison: Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.p-value: <0.00195% CI: [0.45, 0.76]Negative Binomial Regression

Comparison: Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.p-value: 0.04495% CI: [0.58, 0.99]Negative Binomial Regression

Secondary

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

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

Time frame: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	15 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	11 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	137 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	12 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	6 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	35 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	4 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anxious	30 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	22 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	4 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	142 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	18 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	43 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anxious	33 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	8 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	11 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	14 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	8 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> not anxious	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> extremely anxious	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> severely anxious	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> not anxious	4 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> severely anxious	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> moderately anxious	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> slightly anxious	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> moderately anxious	21 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> moderately anxious	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> moderately anxious	8 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> slightly anxious	106 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> not anxious	588 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> severely anxious	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Extremely anxious -> extremely anxious	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> not anxious	177 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> slightly anxious	68 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> no data	5 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> not anxious	10 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> extremely anxious	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> slightly anxious	14 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> severely anxious	5 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> extremely anxious	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> moderately anxious	13 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> moderately anxious	35 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> extremely anxious	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> severely anxious	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> slightly anxious	55 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	No data -> slightly anxious	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Severely anxious -> extremely anxious	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Moderately anxious -> not anxious	37 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Slightly anxious -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Anxiety/Depression	Not anxious -> severely anxious	1 Participants

Secondary

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

Time frame: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	9 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	19 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	120 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	16 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	7 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	44 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	21 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	24 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	11 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> extreme pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discomf	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	119 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	19 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> moderate pain/discomfort	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> severe pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> extreme pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	37 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	48 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	9 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> extreme pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	11 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	17 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	10 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> extreme pain/discomf	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	6 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	5 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> extreme pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discomf	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> extreme pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> severe pain/discomfort	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no pain/discomfort	49 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> moderate pain/discomfort	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> slight pain/discomfort	3 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> extreme pain/discomfort	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> moderate pain/discomf	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> severe pain/discomfort	5 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no pain/discomfort	495 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> severe pain/discomfort	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> moderate pain/discomfort	26 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Extreme pain/discomfort -> extreme pain/discomfort	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> slight pain/discomfort	152 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> slight pain/discomfort	70 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Slight pain/discomfort -> no pain/discomfort	132 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no pain/discomfort	15 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> no pain/discomfort	11 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> slight pain/discomfort	9 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No pain/discomfort -> no data	6 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> moderate pain/discomfort	13 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> severe pain/discomfort	8 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> severe pain/discomfort	11 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> moderate pain/discomf	65 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	No data -> slight pain/discomfort	11 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Moderate pain/discomfort -> slight pain/discomfort	78 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Pain/Discomfort	Severe pain/discomfort -> no data	0 Participants

Secondary

Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care

The EQ-5D questionnaire is 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 has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).

Time frame: Baseline and Month 12

Population: FAS populaton; LOCF was used for EoT.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> no problems	5 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Unable to wash/dress myself -> no problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> slight problems	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no problems	223 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> moderate problems	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no data	5 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> moderate problems	8 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> severe problems	1 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> slight problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> moderate problems	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no problems	16 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> slight problems	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> slight problems	12 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> no problems	6 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> slight problems	9 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> moderate problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Unable to wash/dress myself -> unable to wash/dres	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> moderate problems	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> unable to wash/dress myself	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> slight problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no problems	232 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> slight problems	9 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> moderate problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no problems	18 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> slight problems	14 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> moderate problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> no problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> slight problems	6 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> moderate problems	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> slight problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> moderate problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Unable to wash/dress myself -> unable to wash/dres	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> no problems	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> moderate problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> moderate problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Unable to wash/dress myself -> slight problems	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> moderate problems	12 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no problems	906 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> moderate problems	12 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Unable to wash/dress myself -> unable to wash/dres	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> slight problems	44 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> slight problems	40 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Slight problems -> no problems	64 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no problems	8 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No data -> no problems	22 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> no data	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> moderate problems	4 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> severe problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> severe problems	5 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> moderate problems	21 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Moderate problems -> slight problems	20 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	No problems -> severe problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care	Severe problems -> no data	0 Participants

Secondary

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

Time frame: Baseline and Month 12

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	12 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	11 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	165 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	7 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	4 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	8 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	4 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	27 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	13 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	6 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	28 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	1 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	1 Participants
Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	160 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	16 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	39 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	33 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	6 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	12 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	9 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> moderate problems	6 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no problems	40 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> moderate problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Moderate problems	15 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> moderate problems	4 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> severe problems	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> No problems	672 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> moderate problems	26 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Unable to do usual activities -> unable to do	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> slight problems	85 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> Slight problems	65 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Slight problems -> no problems	131 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no problems	10 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> no problems	20 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> slight problems	9 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No problems -> no data	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> severe problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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 + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> severe problems	6 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> moderate problems	43 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	No data -> slight problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> unable to do usual activities	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Moderate problems -> slight problems	44 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With 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	Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Usual Activities	Severe problems -> no data	0 Participants

Secondary

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

Time frame: Baseline and 12 Months

Population: FAS population; LOCF was used for EoT.

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	14 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	13 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	164 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	9 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	10 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	5 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	4 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	6 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	19 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	15 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	4 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	18 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	4 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	3 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	2 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	1 Participants
Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	164 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	15 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	24 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	29 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	6 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	1 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	11 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	17 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	5 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	2 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	4 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	3 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 Participants
Solifenacin 5 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no problems	38 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> unable to walk about	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no problems	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> moderate problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> slight problems	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> unable to walk about	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> moderate problems	26 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> moderate problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> severe problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no problems	675 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> severe problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> moderate problems	26 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> severe problems	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife 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	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> slight problems	87 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> slight problems	56 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Unable to walk about -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Slight problems -> no problems	83 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no data	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no problems	15 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> no data	1 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> no problems	19 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> slight problems	13 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> unable to walk about	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> no data	7 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> moderate problems	16 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> severe problems	8 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> unable to walk about	0 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> severe problems	15 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> moderate problems	50 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No data -> slight problems	3 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> unable to walk about	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Moderate problems -> slight problems	47 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	No problems -> severe problems	2 Participants
Solifenacin 5 mg + Mirabegron 50 mg	Number of Participants With Change From Baseline to EoT in European Quality of Llife in 5 Dimensions (EQ-5D) Questionnaire Subscale Score: Mobility	Severe problems -> no data	0 Participants

Secondary

Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.

Time frame: Months 1, 3, 6, 9, 12

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	10.37 urgency incontinence episodes	Standard Error 1
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	8.97 urgency incontinence episodes	Standard Error 0.95
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	8.86 urgency incontinence episodes	Standard Error 0.98
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	13.14 urgency incontinence episodes	Standard Error 1.42
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	8.08 urgency incontinence episodes	Standard Error 1.01
Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	7.73 urgency incontinence episodes	Standard Error 1
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	6.51 urgency incontinence episodes	Standard Error 0.89
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	6.06 urgency incontinence episodes	Standard Error 0.85
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	7.04 urgency incontinence episodes	Standard Error 0.86
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	8.12 urgency incontinence episodes	Standard Error 0.98
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	11.21 urgency incontinence episodes	Standard Error 1.19
Solifenacin 5 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	7.31 urgency incontinence episodes	Standard Error 0.96
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	EoT	5.57 urgency incontinence episodes	Standard Error 0.4
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 1	8.99 urgency incontinence episodes	Standard Error 0.47
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 3	6.95 urgency incontinence episodes	Standard Error 0.44
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 6	5.88 urgency incontinence episodes	Standard Error 0.41
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 12	4.88 urgency incontinence episodes	Standard Error 0.38
Solifenacin 5 mg + Mirabegron 50 mg	Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit	Month 9	5.47 urgency incontinence episodes	Standard Error 0.4

Comparison: Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variablep-value: <0.00195% CI: [0.48, 0.79]Negative Binomial Regression

Comparison: Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (\< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variablep-value: 0.02395% CI: [0.58, 0.96]Negative Binomial Regression

Secondary

Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The HRQoL portion of the OAB-q consists of 25 HRQoL items comprising 4 HRQoL subscales, each item was scored 1-6. The total 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.The PPBC is 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	25.2 percentage of participants
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	33.3 percentage of participants
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	36.8 percentage of participants
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	39.0 percentage of participants
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	44.1 percentage of participants
Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	40.1 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	45.2 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	29.0 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	44.0 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	47.6 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	39.1 percentage of participants
Solifenacin 5 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	41.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	45.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	49.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	53.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	51.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	35.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	54.6 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.33, 2.34]Regression, Logistic

Secondary

Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT

The PGIC is 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: Month 12

Population: FAS population with data available. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: No change	6.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much worse	1.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally improved	21.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally improved	22.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much worse	0.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much improved	30.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much improved	31.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much improved	25.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally worse	0.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: No change	5.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much worse	0.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much improved	25.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally worse	0.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much worse	1.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: No change	7.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much improved	23.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much improved	35.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally improved	19.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: No change	6.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally worse	0.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much worse	0.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much worse	0.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much improved	24.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much improved	37.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally improved	20.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally worse	0.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much worse	0.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much worse	0.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much worse	0.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally improved	16.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally worse	0.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: No change	4.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: No change	5.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Minimally improved	16.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much improved	33.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Minimally worse	0.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much improved	34.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much improved	34.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Very much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Very much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	EoT: Much improved	34.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT	Month 12: Much worse	0.1 percentage of participants

Secondary

Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT

Time frame: Month 12

Population: FAS population with data available. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: No change	25.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much worse	0.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally improved	18.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally improved	19.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much worse	0.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much improved	23.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much improved	24.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much improved	13.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally worse	3.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: No change	24.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much worse	0.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much improved	12.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally worse	3.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much worse	1.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: No change	25.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much improved	14.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much improved	26.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally improved	17.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: No change	24.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally worse	2.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much worse	0 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much worse	0.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much improved	15.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much improved	27.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally improved	18.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally worse	3.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much worse	0.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much worse	0.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much worse	0.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally improved	19.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally worse	2.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: No change	20.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: No change	21.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Minimally improved	18.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much improved	18.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Minimally worse	2.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much improved	28.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much improved	18.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Very much worse	0.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Very much worse	0.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	EoT: Much improved	28.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 12 and EoT	Month 12: Much worse	0.4 percentage of participants

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 Months 1, 3, 6, 9, 12 and EoT

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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
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 Months 1, 3, 6, 9, 12 and EoT	EoT	44.3 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	43.7 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	28.5 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	46.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	41.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	39.6 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 HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT	Month 12	50.4 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	36.6 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 HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT	Month 6	47.9 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 HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT	Month 9	51.2 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	43.8 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 Months 1, 3, 6, 9, 12 and EoT	EoT	49.0 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	52.3 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	60.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	55.3 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	40.9 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 10 Points Improvement on OAB-q HRQL Total Score) at Months 1, 3, 6, 9, 12 and EoT	Month 9	57.6 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 Months 1, 3, 6, 9, 12 and EoT	EoT	59.2 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.46, 2.54]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.2, 2.09]Regression, Logistic

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 Months 1, 3, 6, 9, 12 and EoT

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 in a micturition diary for 7 days prior to each visit. The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
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 Months 1, 3, 6, 9, 12 and EoT	Month 1	36.1 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 Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT	Month 3	47.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	50.4 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	53.1 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 Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT	Month 12	59.2 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 Months 1, 3, 6, 9, 12 and EoT	EoT	55.7 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 Months 1, 3, 6, 9, 12 and EoT	EoT	58.2 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	46.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	61.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	60.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	55.5 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	56.9 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 10 Points Improvement on OAB-q Symptom Bother Scale) at Months 1, 3, 6, 9, 12 and EoT	Month 3	65.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	65.8 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 Months 1, 3, 6, 9, 12 and EoT	EoT	70.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	69.2 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	52.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	73.2 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.5, 2.62]Regression, Logistic

Comparison: Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.35, 2.36]Regression, Logistic

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 Months 1, 3, 6, 9, 12 and EoT

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 in a micturition diary for 7 days prior to each visit. The PPBC is 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
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 Months 1, 3, 6, 9, 12 and EoT	Month 12	57.6 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 Months 1, 3, 6, 9, 12 and EoT	EoT	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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	49.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	32.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	43.3 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	46.8 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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	52.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	60.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	37.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	47.7 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 Months 1, 3, 6, 9, 12 and EoT	EoT	57.5 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	53.2 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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	65.1 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	63.0 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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	60.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	46.0 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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	67.0 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 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	57.6 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.p-value: <0.00195% CI: [1.28, 2.26]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours and baseline PPBC as covariates.p-value: 0.01995% CI: [1.06, 1.86]Regression, Logistic

Secondary

Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit. The symptom bother portion of the OAB-q consists 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.The PPBC is 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	29.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	42.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	46.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	51.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	47.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	51.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	35.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	50.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	53.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	44.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	46.1 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 3	54.1 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 6	55.9 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	EoT	61.7 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 9	59.2 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 1	42.8 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, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT	Month 12	63.7 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.4, 2.46]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.19, 2.09]Regression, Logistic

Secondary

Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 1	46.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 3	53.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 6	56.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 9	57.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 12	58.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	EoT	56.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	EoT	61.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 1	53.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 9	62.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 12	62.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 3	59.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 6	62.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 3	64.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 6	66.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	EoT	68.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 9	67.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 1	57.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT	Month 12	69.0 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: <0.00195% CI: [1.36, 2.43]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: 0.01495% CI: [1.08, 1.92]Regression, Logistic

Secondary

Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT

The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The symptom bother portion consists 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 Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 1	63.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 3	69.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 6	70.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 9	70.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 12	72.8 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	EoT	70.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	EoT	72.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 1	67.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 9	76.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 12	74.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 3	71.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT	Month 6	74.6 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	81.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	80.5 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 Months 1, 3, 6, 9, 12 and EoT	EoT	82.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	82.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	72.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	84.4 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: <0.00195% CI: [1.49, 2.78]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline OAB-q subscale as a covariate.p-value: <0.00195% CI: [1.37, 2.57]Regression, Logistic

Secondary

Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	53.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	61.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	64.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	65.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	69.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	66.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	71.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	59.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	68.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	73.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	65.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	68.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	72.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	73.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	76.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	75.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	64.1 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	76.9 percentage of participants

Comparison: Odds ratio is from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.24, 2.29]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.p-value: 0.10995% CI: [0.94, 1.77]Regression, Logistic

Secondary

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 1	46.7 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 3	58.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 6	63.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 9	67.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 12	72.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	EoT	69.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	EoT	73.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 1	55.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 9	73.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 12	75.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 3	67.0 percentage of participants
Solifenacin 5 mg	Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT	Month 6	71.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	73.3 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	76.6 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 Months 1, 3, 6, 9, 12 and EoT	EoT	79.5 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	77.8 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	62.0 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	81.3 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: <0.00195% CI: [1.34, 2.41]Regression, Logistic

Comparison: Odds ratio wa from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.01995% CI: [1.06, 1.95]Regression, Logistic

Secondary

Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	24.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	31.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	35.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	37.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	40.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	38.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	39.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	28.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	40.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	40.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	33.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	38.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 3	42.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 6	45.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	EoT	50.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 9	47.0 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 1	30.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT	Month 12	51.9 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.26, 2.25]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline PPBC as a covariate.p-value: <0.00195% CI: [1.22, 2.16]Regression, Logistic

Secondary

Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT

The percentage of participants with micturition frequency normalization was defined as participants who had ≥ 8 micturitions/24 hours at baseline and \< 8 micturitions/24 hours postbaseline at months 1, 3, 6, 9, 12 and EoT.

Time frame: Baseline and Months 1, 3, 6, 9, 12

Population: FAS with data available at each time point. Participants with less \< 8 micturitions per 24 hours at baseline were not included in the analysis. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 12	46.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	EoT	46.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 6	42.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 1	34.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 9	44.5 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 3	36.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 1	29.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 12	44.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 3	36.6 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 6	43.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	EoT	46.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 9	41.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	EoT	55.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 1	36.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 3	46.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 6	51.4 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 9	52.5 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT	Month 12	56.4 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00295% CI: [1.18, 2.03]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.p-value: 0.00695% CI: [1.12, 1.95]Regression, Logistic

Secondary

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the last 3 days of the 7-day micturition diary is reported.

Time frame: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 6	40.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 1	24.4 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 3	40.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 9	47.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 12	51.6 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	EoT	47.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 3	44.8 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 6	50.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 9	54.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	EoT	53.2 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 12	55.5 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 1	39.9 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 1	38.3 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 12	61.2 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 6	54.7 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	EoT	58.8 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 3	49.6 percentage of participants
Solifenacin 5 mg + Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 9	55.8 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: [1.26, 2.15]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history 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: 0.0895% CI: [0.97, 1.67]Regression, Logistic

Secondary

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT

An incontinence episode was defined as the complaint of any involuntary leakage of urine. The percentage of participants with no incontinence episodes recorded during the 7-day micturition diary is reported.

Time frame: Months 1, 3, 6, 9, 12

Population: FAS population with data available at each time point. LOCF was used for EoT.

Arm	Measure	Group	Value (NUMBER)
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 1	17.2 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 3	27.0 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 6	32.3 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 9	37.1 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 12	41.9 percentage of participants
Mirabegron 50 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	EoT	38.9 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	EoT	45.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 1	26.4 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 9	43.7 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 12	47.3 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 3	35.1 percentage of participants
Solifenacin 5 mg	Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 7 Diary Days at Months 1, 3, 6, 9, 12 and EoT	Month 6	39.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 3	40.0 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 Months 1, 3, 6, 9, 12 and EoT	Month 6	44.7 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 Months 1, 3, 6, 9, 12 and EoT	EoT	49.7 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 Months 1, 3, 6, 9, 12 and EoT	Month 9	46.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 1	27.9 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 Months 1, 3, 6, 9, 12 and EoT	Month 12	52.5 percentage of participants

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: <0.00195% CI: [1.26, 2.19]Regression, Logistic

Comparison: Odds ratio was from a logistic regression model including treatment group, sex, age group (\< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of incontinence episodes per 24 hours as a covariate.p-value: 0.13395% CI: [0.94, 1.62]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026

A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

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Study design

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Exclusion criteria

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Secondary

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Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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

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

Change From Baseline to EoT in Corrected Micturition Frequency

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 the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Patient Perception of Bladder Condition (PPBC)

Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Postvoid Residual (PVR) Volume

Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours

Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score

Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS

Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition

Change From Baseline to Months 6, 12 and EoT in Work Productivity and Activity Impairment: Specific Health Problem Questionnaire (WPAI:SHP) Score: Percent Work Time Missed

Change From Baseline to Months 6, 12 and EoT in WPAI:SHP Score: Percent Impairment While Working

Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Activity Impairment

Change From Baseline to Months 6, 12 in WPAI:SHP Score: Percent Overall Work Impairment

Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)

Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit

Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit

Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit

Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit

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

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

Number of Participants With Change From Baseline to EoT in EQ-5D Questionnaire Subscale Score: Self-care

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

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

Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit

Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q HRQL Total Score and ≥ 1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants in Each Category of Patient's Global Impression of Change (PGIC) Scale: Impression in Bladder Symptoms at Month 12 and EoT

Percentage of Participants in Each Category of PGIC Scale: Impression in General Health at Month 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 Months 1, 3, 6, 9, 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 Months 1, 3, 6, 9, 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 Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants Who Were Triple Responders (≥ 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours, ≥ 10 Points Improvement on OAB-q Symptom Bother Scale and ≥1 Point Improvement on PPBC) at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With ≥ 10 Points Improvement From Baseline in HRQoL Total Score at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With ≥ 10 Points Improvement From Baseline in the OAB-q Symptom Bother Score at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With ≥ 1 Point Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With 50% Reduction in Mean Number of Incontinence Episodes Per 24 Hours at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With Major (≥ 2 Points) Improvement From Baseline in PPBC at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With Micturition Frequency Normalization at Months 1, 3, 6, 9, 12 and EoT

Percentage of Participants With Zero Incontinence Episodes Per 24 Hours Using the Last 3 Diary Days at Months 1, 3, 6, 9, 12 and EoT