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A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.

A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01638000
Acronym
BEYOND
Enrollment
1887
Registered
2012-07-11
Start date
2012-06-12
Completion date
2013-04-24
Last updated
2024-11-21

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

Conditions

Urinary Bladder Diseases, Urinary Bladder, Overactive, Urologic Diseases

Keywords

Vesitrim, Frequency, Urgency, Urgency incontinence, Urinary incontinence, Overactive Bladder (OAB), Micturition, Mirabegron, YM178, Vesicare, Solifenacin

Brief summary

The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.

Interventions

DRUGMirabegron

oral tablet

DRUGSolifenacin succinate

oral tablet

Sponsors

Astellas Pharma Europe Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject is willing and able to complete the micturition diary and questionnaires correctly * Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months * Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit

Exclusion criteria

* Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control * Subject has neurogenic bladder * Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test) * Subject has an indwelling catheter or practices intermittent self-catheterization * Subject has diabetic neuropathy * Subject has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs * Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated * The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening * Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening) * Subject has moderate to severe hepatic impairment * Subject has severe renal impairment or end stage renal disease * Subject has severe uncontrolled hypertension * Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval * Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients * Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening * Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives * Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria * Subject's last antimuscarinic treatment was solifenacin

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 HoursBaseline and final visit (up to Week 12)A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Secondary

MeasureTime frameDescription
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursBaseline and Week 4, Week 8, Week 12
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4, Week 8, Week 12An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursBaseline and Week 4, Week 8, Week 12An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4, Week 8, Week 12An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursBaseline and Week 4, Week 8, Week 12An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursBaseline and Week 4, Week 8, Week 12An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyBaseline and Week 4, Week 8, Week 12Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4, Week 8, Week 12The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentBaseline and Week 4, Week 8 , Week 12The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4, Week 8, Week 12A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentBaseline and Week 4, Week 8, Week 12A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 4, Week 8, Week 12A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0.
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4, Week 8, Week 12A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4, Week 8, Week 12A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireBaseline and Week 4The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 4The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 4The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 4The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 4The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 8The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 8The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 8The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 8The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 8The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 12The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 12The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 12The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 12The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and Week 12The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and final visit (up to Week 12)The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and final visit (up to Week 12)The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and final visit (up to Week 12)The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and final visit (up to Week 12)The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireBaseline and final visit (up to Week 12)The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Baseline and Week 4, Week 8, Week 12The Overactive Bladder Questionnaire (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, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qBaseline and Week 4, Week 8, Week 12The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is 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 indicates an improvement.
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Baseline and Week 4, Week 8, Week 12The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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 Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)Baseline and Week 12The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert ScaleBaseline and Week 12The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final VisitBaseline to Week 12A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodFrom first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks)A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12Baseline to Week 12A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final VisitBaseline to final visit (up to Week 12)A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale.
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final VisitBaseline to Week 12A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final VisitBaseline to Week 12A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final VisitBaseline to Week 12A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline.

Countries

Armenia, Austria, Belarus, Belgium, Bulgaria, Canada, Czechia, Denmark, Finland, France, Georgia, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Lebanon, Lithuania, Netherlands, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom

Participant flow

Recruitment details

Participants recruited for this study were men and women with overactive bladder (OAB) who had received 1 or more antimuscarinics in the past and who were dissatisfied with their last antimuscarinic treatment due to lack of efficacy (provided that their previous antimuscarinic was not solifenacin).

Pre-assignment details

Participants entered a 2-week, single-blind, placebo run-in period and completed a daily diary (including 3 consecutive days prior to the randomization visit for micturition and incontinence). After this, participants' eligibility criteria were re-confirmed and they were then randomized into the double-blind treatment period of the study.

Participants by arm

ArmCount
Mirabegron 50 mg
Participants who received mirabegron 50 mg once daily for 12 weeks.
936
Solifenacin 5 mg
Participants who received solifenacin 5 mg once daily for 12 weeks.
934
Total1,870

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyAdverse Event1416
Overall StudyLack of Efficacy56
Overall StudyMiscellaneous22
Overall StudyProtocol Violation1113
Overall StudyRandomized but Never Received Drug710
Overall StudyWithdrawal by Subject2124

Baseline characteristics

CharacteristicSolifenacin 5 mgTotalMirabegron 50 mg
Age, Continuous57.4 years
STANDARD_DEVIATION 13.6
57.0 years
STANDARD_DEVIATION 13.93
56.7 years
STANDARD_DEVIATION 14.25
Mean Incontinence Episodes / 24 hours2.1 incontinence episodes
STANDARD_DEVIATION 2.05
2.1 incontinence episodes
STANDARD_DEVIATION 2.17
2.1 incontinence episodes
STANDARD_DEVIATION 2.3
Mean Level of Urgency2.6 units on a scale
STANDARD_DEVIATION 0.49
2.6 units on a scale
STANDARD_DEVIATION 0.49
2.6 units on a scale
STANDARD_DEVIATION 0.49
Mean Micturitions / 24 hours11.4 micturitions
STANDARD_DEVIATION 2.89
11.5 micturitions
STANDARD_DEVIATION 3.08
11.6 micturitions
STANDARD_DEVIATION 3.25
Mean Nocturia Episodes / 24 hours2.3 nocturia episodes
STANDARD_DEVIATION 1.42
2.3 nocturia episodes
STANDARD_DEVIATION 1.41
2.3 nocturia episodes
STANDARD_DEVIATION 1.41
Mean Number of Pads Used / 24 hours3.3 pads
STANDARD_DEVIATION 3.7
3.2 pads
STANDARD_DEVIATION 3.57
3.1 pads
STANDARD_DEVIATION 3.43
Mean Urgency Episodes (grade 3 or 4) / 24 hours7.8 urgency episodes
STANDARD_DEVIATION 4.46
7.8 urgency episodes
STANDARD_DEVIATION 4.61
7.7 urgency episodes
STANDARD_DEVIATION 4.75
Mean Urgency Incontinence Episodes / 24 hours2.0 urgency incontinence episodes
STANDARD_DEVIATION 1.94
2.0 urgency incontinence episodes
STANDARD_DEVIATION 1.96
1.9 urgency incontinence episodes
STANDARD_DEVIATION 1.99
Sex: Female, Male
Female
709 Participants1421 Participants712 Participants
Sex: Female, Male
Male
225 Participants449 Participants224 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
29 / 93654 / 934
serious
Total, serious adverse events
14 / 93613 / 934

Outcome results

Primary

Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours

A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and final visit (up to Week 12)

Population: Per Protocol Set (PPS) - all randomized participants who took ≥1 dose of double-blind study drug and who recorded ≥1 micturition in the baseline diary and ≥1 micturition in a post-baseline diary who had completed the study with no major protocol violations which could impact the primary endpoint. Last observation carried forward (LOCF) was used.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours-2.95 micturitionsStandard Error 0.087
Solifenacin 5 mgChange From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours-3.13 micturitionsStandard Error 0.088
Comparison: The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.p-value: 0.1595% CI: [-0.42, 0.06]ANCOVA
Secondary

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

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS population. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 4 [N=877,871]-0.72 nocturia episodesStandard Error 0.033
Mirabegron 50 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 8 [N=850,844]-0.90 nocturia episodesStandard Error 0.031
Mirabegron 50 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 12 [N=831,828]-0.98 nocturia episodesStandard Error 0.032
Solifenacin 5 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 4 [N=877,871]-0.63 nocturia episodesStandard Error 0.034
Solifenacin 5 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 8 [N=850,844]-0.87 nocturia episodesStandard Error 0.031
Solifenacin 5 mgChange From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 12 [N=831,828]-0.97 nocturia episodesStandard Error 0.033
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.05895% CI: [0, 0.18]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.595% CI: [-0.06, 0.12]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.8195% CI: [-0.08, 0.1]ANCOVA
Secondary

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

The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and Week 4, Week 8 , Week 12

Population: FAS population. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 4 [M=574,563]-1.80 padsStandard Error 0.081
Mirabegron 50 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 8 [N=551,543]-2.10 padsStandard Error 0.07
Mirabegron 50 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 12 [N=543,532]-2.14 padsStandard Error 0.078
Solifenacin 5 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 12 [N=543,532]-2.20 padsStandard Error 0.079
Solifenacin 5 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 4 [M=574,563]-1.82 padsStandard Error 0.081
Solifenacin 5 mgChange From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of TreatmentWeek 8 [N=551,543]-2.14 padsStandard Error 0.07
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.8495% CI: [-0.25, 0.2]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.6395% CI: [-0.24, 0.15]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.5995% CI: [-0.28, 0.16]ANCOVA
Secondary

Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency

Urgency level was rated by the participant during the 3-day micturition diary period using the PPIUS 5-point categorical scale: 0. No urgency; 1. Mild urgency; 2. Moderate urgency; 3. Severe urgency; 4. Urgency incontinence.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 4 [N=916,906]-0.36 units on a scaleStandard Error 0.016
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 12 [N=870,856]-0.60 units on a scaleStandard Error 0.023
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 8 [N=888,876]-0.50 units on a scaleStandard Error 0.019
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyFinal visit [N=920,910]-0.58 units on a scaleStandard Error 0.022
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyFinal visit [N=920,910]-0.57 units on a scaleStandard Error 0.022
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 4 [N=916,906]-0.36 units on a scaleStandard Error 0.017
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 8 [N=888,876]-0.52 units on a scaleStandard Error 0.019
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of UrgencyWeek 12 [N=870,856]-0.60 units on a scaleStandard Error 0.023
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.9995% CI: [-0.05, 0.05]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.4795% CI: [-0.07, 0.03]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.9995% CI: [-0.06, 0.06]ANCOVA
Comparison: Final visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.7495% CI: [-0.05, 0.07]ANCOVA
Secondary

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

An urgency episode is a sudden compelling desire to pass urine immediately followed by an incontinent event or the patient having to rush to the toilet and make it in time; severity recorded as 3 (severe urgency) or 4 (urgency incontinence) on the Patient Perception of the Intensity of Urgency Scale (PPIUS) validated scale. The mean number of urgency episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. Only participants with at least one urgency episode (grade 3 or 4) at baseline were included in this analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 4 [N=915,905]-3.75 urgency episodesStandard Error 0.113
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 8 [N=887,875]-4.44 urgency episodesStandard Error 0.111
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 12 [N=869,855]-4.67 urgency episodesStandard Error 0.116
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursFinal Visit [N=919,909]-4.61 urgency episodesStandard Error 0.115
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursFinal Visit [N=919,909]-4.84 urgency episodesStandard Error 0.115
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 12 [N=869,855]-4.99 urgency episodesStandard Error 0.117
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 4 [N=915,905]-3.88 urgency episodesStandard Error 0.114
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 HoursWeek 8 [N=887,875]-4.79 urgency episodesStandard Error 0.112
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.4395% CI: [-0.44, 0.19]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.02795% CI: [-0.66, -0.04]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.05395% CI: [-0.64, 0]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.1695% CI: [-0.55, 0.09]ANCOVA
Secondary

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

An incontinence episode is any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS-I population. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 4 [N=404,410]-1.22 incontinence episodesStandard Error 0.063
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 8 [N=387,397]-1.37 incontinence episodesStandard Error 0.093
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 12 [N=381,387]-1.41 incontinence episodesStandard Error 0.115
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 4 [N=404,410]-1.30 incontinence episodesStandard Error 0.063
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 8 [N=387,397]-1.59 incontinence episodesStandard Error 0.092
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 HoursWeek 12 [N=381,387]-1.66 incontinence episodesStandard Error 0.114
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.3695% CI: [-0.25, 0.1]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.1295% CI: [-0.48, 0.03]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.4795% CI: [-0.57, 0.07]ANCOVA
Secondary

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

Time frame: Baseline and Week 4, Week 8, Week 12

Population: Full Analysis Set (FAS) - consisted of all randomized participants who took ≥ 1 dose of double-blind study drug and who recorded ≥1 micturition measurement in the baseline diary and ≥1 micturition measurement in a post-baseline diary. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 4 [N=916,906]-2.37 micturitionsStandard Error 0.083
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 8 [N=888,876]-2.77 micturitionsStandard Error 0.084
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 12 [N=870,856]-3.02 micturitionsStandard Error 0.088
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 4 [N=916,906]-2.33 micturitionsStandard Error 0.083
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 8 [N=888,876]-3.00 micturitionsStandard Error 0.085
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 HoursWeek 12 [N=870,856]-3.21 micturitionsStandard Error 0.089
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.7195% CI: [-0.19, 0.27]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.05395% CI: [-0.47, 0]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.1295% CI: [-0.44, 0.05]ANCOVA
Secondary

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

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The mean number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS-I population. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 4 [N=395,399]-1.22 urgency incontinence episodesStandard Error 0.057
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 8 [N=379,386]-1.39 urgency incontinence episodesStandard Error 0.05
Mirabegron 50 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 12 [N=373,377]-1.49 urgency incontinence episodesStandard Error 0.047
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 4 [N=395,399]-1.24 urgency incontinence episodesStandard Error 0.057
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 8 [N=379,386]-1.56 urgency incontinence episodesStandard Error 0.05
Solifenacin 5 mgChange From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 HoursWeek 12 [N=373,377]-1.59 urgency incontinence episodesStandard Error 0.047
Comparison: Week 4 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.6695% CI: [-0.18, 0.14]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.1795% CI: [-0.31, -0.03]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg.p-value: 0.6695% CI: [-0.24, 0.02]ANCOVA
Secondary

Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and final visit (up to Week 12)

Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems38 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems25 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems8 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems12 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems133 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems55 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems10 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems6 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems52 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems92 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems22 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems26 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems55 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems332 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems356 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems52 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems121 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems83 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems17 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems68 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems45 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems29 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems35 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems18 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems15 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems7 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and final visit (up to Week 12)

Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems53 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems17 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems6 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems20 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems80 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems60 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems14 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems33 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems45 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems36 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems16 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems5 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems37 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems460 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems471 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems25 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems12 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems88 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems34 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems18 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems67 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems46 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems31 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems52 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems17 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems11 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems11 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and final visit (up to Week 12)

Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems39 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems16 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems16 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems116 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems80 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems51 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems103 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems48 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems30 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems55 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems297 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems306 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems52 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems13 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems118 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems93 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems20 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems83 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems72 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems44 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems7 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems34 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems14 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems5 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems5 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and final visit (up to Week 12)

Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems27 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems5 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems43 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems45 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems8 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems6 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems25 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems5 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems8 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems697 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems25 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems26 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems7 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems43 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems14 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems46 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems8 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems699 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Secondary

Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and final visit (up to Week 12)

Population: FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems31 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems9 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems6 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems106 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems83 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problem1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems42 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problem2 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems45 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problem1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems29 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problem1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems46 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems444 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems440 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems49 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems8 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems113 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems54 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems9 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems79 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems34 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems20 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems41 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems14 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems8 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems7 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problem2 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problem3 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problem1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problem1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems8 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale

The Treatment Satisfaction (TS)-Likert Scale was a self-rated scale with the participant answering the question How satisfied were you with your treatment? with on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied).

Time frame: Baseline and Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert ScaleWeek 12 [N=876,871]2.92 units on a scaleStandard Error 0.05
Mirabegron 50 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert ScaleFinal visit [N=897,889]2.88 units on a scaleStandard Error 0.05
Solifenacin 5 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert ScaleWeek 12 [N=876,871]3.07 units on a scaleStandard Error 0.05
Solifenacin 5 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert ScaleFinal visit [N=897,889]3.03 units on a scaleStandard Error 0.05
Comparison: Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.02795% CI: [0.02, 0.29]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.03495% CI: [0.01, 0.29]ANCOVA
Secondary

Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)

The Treatment Satisfaction (TS)-Visual Analogue Scale (VAS) was a self-rated scale with the participant answering the question Are you satisfied with your treatment? and placing a vertical mark on a line from 0 (No, not at all) to 10 (Yes, completely).

Time frame: Baseline and Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)Week 12 [N=865,857]3.51 units on a scaleStandard Error 0.099
Mirabegron 50 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)Final visit [N=891,876]3.44 units on a scaleStandard Error 0.099
Solifenacin 5 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)Week 12 [N=865,857]3.93 units on a scaleStandard Error 0.1
Solifenacin 5 mgChange From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)Final visit [N=891,876]3.86 units on a scaleStandard Error 0.1
Comparison: Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.00295% CI: [0.15, 0.7]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.00395% CI: [0.14, 0.7]ANCOVA
Secondary

Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 12

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems38 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data16 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems25 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems9 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems132 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems52 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems51 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems84 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems18 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems8 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems26 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems53 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems323 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems341 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems48 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data20 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems118 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems80 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems67 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems44 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems28 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems35 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems17 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems14 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems15 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 12

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems43 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems35 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems18 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data26 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data6 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems77 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems15 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems6 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems57 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems442 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems36 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems31 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems53 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data16 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems82 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems32 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems16 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems51 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems17 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems8 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data10 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data11 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems63 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems43 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems30 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems459 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems25 participants
Secondary

Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 12

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems39 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data17 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems14 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems16 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems12 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data12 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems112 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems79 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems49 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems97 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems42 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems29 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems50 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data10 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems287 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems299 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems49 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data15 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems116 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems87 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems18 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data10 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems80 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems71 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems38 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data13 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems34 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems13 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems12 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 12

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems25 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems4 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data36 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems667 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems44 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems43 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems8 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems5 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems13 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems8 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems26 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems14 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems23 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data36 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems42 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems12 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems46 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems25 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems670 participants
Secondary

Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 12

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems31 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data27 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems6 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems9 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data6 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems103 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems81 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems14 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems41 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems2 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems45 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems25 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems12 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems43 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems425 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems426 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems45 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data22 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems107 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems53 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems79 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems31 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data9 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems40 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems13 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems7 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems8 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 4

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems12 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems32 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems26 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems12 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems98 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems25 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems7 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems64 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems122 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems37 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems12 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems29 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems59 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems5 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems328 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems339 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems65 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems102 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems94 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems25 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems33 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems65 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems40 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems17 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems29 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems19 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems9 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems12 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire

The European Quality of Life 5-Dimensions Questionnaire (EQ-5D-5L) is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 4

Population: FAS population who have non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> moderate problems45 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> slight problems47 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> severe problems16 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> no problems39 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> slight problems39 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> no problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> moderate problems24 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> moderate problems50 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> severe problems6 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> no problems66 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> no problems20 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> slight problems24 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> No problems447 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Slight problems45 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Moderate problems23 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Slight problems43 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Moderate problems19 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> Extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> no problems80 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> slight problems47 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> moderate problems11 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSlight problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> no problems51 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> slight problems45 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> moderate problems46 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireModerate problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> no problems16 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> slight problems34 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> moderate problems29 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> severe problems12 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireSevere problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo data -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) QuestionnaireNo problems -> No problems443 participants
Secondary

Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 4

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems60 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems299 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems57 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems101 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems116 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems32 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems51 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems66 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extrme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems21 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems22 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems19 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems20 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems65 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems97 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems19 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems109 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems12 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems25 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems17 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extrme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems25 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems285 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems67 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems44 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems17 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems86 participants
Secondary

Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 4

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems9 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data5 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems13 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems7 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> No problems37 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems24 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems12 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems18 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems28 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems17 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems26 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> No problems693 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> No problems703 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems23 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> No problems41 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems16 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems17 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems28 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems15 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems15 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 4

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems17 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems21 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems11 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems102 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems47 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems20 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems59 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems5 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems49 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems45 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems9 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems14 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems61 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems421 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems422 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems63 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems10 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems101 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems58 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems16 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems34 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems59 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems39 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems28 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems19 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems13 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems7 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems5 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 8

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems11 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems11 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems50 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems325 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems52 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems42 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data10 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems122 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems9 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems94 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems31 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems26 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems5 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems23 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data6 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems39 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems49 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems59 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems34 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data5 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems13 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems37 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems12 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems11 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems10 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems20 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems334 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems65 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems8 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data13 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems116 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems79 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems2 participants
Secondary

Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 8

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems30 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data14 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems30 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems21 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems20 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data6 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems70 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems51 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems20 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems41 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems46 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> modrate problems31 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems8 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems19 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems38 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems445 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems446 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems31 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems23 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data11 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems78 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems44 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems12 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems47 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems52 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> modrate problems40 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems22 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems41 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems8 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data7 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Secondary

Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 8

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems17 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems13 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data10 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems103 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems111 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems25 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems6 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems59 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems66 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems46 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems37 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems12 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems18 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data8 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems291 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems52 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems66 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems57 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems16 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems286 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data10 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems96 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems103 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems30 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data5 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems61 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems78 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data8 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems16 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems25 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems7 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems1 participants
Secondary

Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 8

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems672 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems35 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data20 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems42 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems19 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems9 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> exteme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems34 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems17 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems5 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems17 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems9 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems4 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems34 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems16 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems15 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems8 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems13 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data21 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems673 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems5 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems38 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems33 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems20 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems9 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> exteme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems0 participants
Secondary

Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire

The EQ-5D-5L is a standardized nondisease specific (i.e., generic) instrument for use as a measure of health outcome. It has 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension has 5 response levels (e.g., no problems with performing activity, slight problems, moderate problems, severe problems, unable to perform \[extreme problems\]).

Time frame: Baseline and Week 8

Population: FAS population who has non-missing values at both Baseline and specified visit.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems16 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems430 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems48 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems15 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data16 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data6 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems45 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems101 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems61 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems57 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems26 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems10 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems13 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems23 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems12 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems7 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems5 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems2 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data1 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems3 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems5 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Mirabegron 50 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no data6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> moderate problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no problems426 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no problems16 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> slight problems49 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> moderate problems11 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> slight problems32 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> severe problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> moderate problems15 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo problems -> no data13 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> extreme problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no problems109 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> severe problems3 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> slight problems50 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> extreme problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> moderate problems12 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> severe problems2 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> slight problems1 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSevere problems -> no data5 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireSlight problems -> no data4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> moderate problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> no problems53 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no problems4 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> slight problems53 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> no data0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> extreme problems0 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> moderate problems20 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireExtreme problems -> slight problems5 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireModerate problems -> severe problems6 participants
Solifenacin 5 mgChange From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L QuestionnaireNo data -> severe problems0 participants
Secondary

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)

The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical 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 Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 4 [N=905,896]-0.91 units on a scaleStandard Error 0.035
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 8 [N=882,875]-1.30 units on a scaleStandard Error 0.038
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 12 [N=865,858]-1.58 units on a scaleStandard Error 0.042
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Final visit [N=906,897]-1.53 units on a scaleStandard Error 0.042
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Final visit [N=906,897]-1.67 units on a scaleStandard Error 0.042
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 4 [N=905,896]-1.00 units on a scaleStandard Error 0.035
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 12 [N=865,858]-1.73 units on a scaleStandard Error 0.042
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)Week 8 [N=882,875]-1.46 units on a scaleStandard Error 0.038
Comparison: Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.0795% CI: [-0.19, 0.01]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.00395% CI: [-0.27, -0.06]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron.Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.01595% CI: [-0.26, -0.03]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.02195% CI: [-0.25, -0.02]ANCOVA
Secondary

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)

The Overactive Bladder Questionnaire (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, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 4 [N=905,896]-20.51 units on a scaleStandard Error 0.576
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 8 [N=882,875]-25.96 units on a scaleStandard Error 0.599
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 12 [N=865,859]-29.74 units on a scaleStandard Error 0.647
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Final visit [N=906,897]-28.89 units on a scaleStandard Error 0.652
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 12 [N=865,859]-31.84 units on a scaleStandard Error 0.649
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Final visit [N=906,897]-30.76 units on a scaleStandard Error 0.655
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 8 [N=882,875]-27.76 units on a scaleStandard Error 0.601
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)Week 4 [N=905,896]-22.20 units on a scaleStandard Error 0.579
Comparison: Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.03995% CI: [-3.29, -0.08]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.03495% CI: [-3.46, -0.13]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.02295% CI: [-3.9, -0.3]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.04395% CI: [-3.68, -0.06]ANCOVA
Secondary

Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q

The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is 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 indicates an improvement.

Time frame: Baseline and Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 4 [N=905,896]17.09 units on a scaleStandard Error 0.543
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 8 [N=882,875]21.66 units on a scaleStandard Error 0.568
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 12 [N=865,859]25.31 units on a scaleStandard Error 0.611
Mirabegron 50 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qFinal visit [N=906,897]24.53 units on a scaleStandard Error 0.616
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qFinal visit [N=906,897]25.94 units on a scaleStandard Error 0.619
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 4 [N=905,896]18.23 units on a scaleStandard Error 0.546
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 12 [N=865,859]26.85 units on a scaleStandard Error 0.613
Solifenacin 5 mgChange From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-qWeek 8 [N=882,875]23.20 units on a scaleStandard Error 0.57
Comparison: Week 4 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.1495% CI: [-0.37, 2.65]ANCOVA
Comparison: Week 8 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.05595% CI: [-0.03, 3.13]ANCOVA
Comparison: Week 12 Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.07495% CI: [-0.15, 3.25]ANCOVA
Comparison: Final Visit Difference vs. Mirabegron. Difference of the adjusted mean is calculated by subtracting the adjusted mean of mirabegron from the adjusted mean of solifenacin.p-value: 0.1195% CI: [-0.3, 3.12]ANCOVA
Secondary

Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An incontinence episode is any involuntary leakage of urine. The total number of incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS-Incontinence (FAS-I) - consisted of all FAS participants with ≥1 incontinence episode at baseline. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (MEAN)Dispersion
Mirabegron 50 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=404,410]2.64 incontinence episodesStandard Error 0.28
Mirabegron 50 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=387,397]2.19 incontinence episodesStandard Error 0.457
Mirabegron 50 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=381,387]2.07 incontinence episodesStandard Error 0.562
Mirabegron 50 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=404,413]2.13 incontinence episodesStandard Error 0.533
Solifenacin 5 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=404,413]1.29 incontinence episodesStandard Error 0.157
Solifenacin 5 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=404,410]2.25 incontinence episodesStandard Error 0.217
Solifenacin 5 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=381,387]1.08 incontinence episodesStandard Error 0.124
Solifenacin 5 mgNumber of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=387,397]1.28 incontinence episodesStandard Error 0.135
Comparison: Week 4 Rate Ratio vs. Mirabegron.p-value: 0.3395% CI: [0.73, 1.11]Poisson regression
Comparison: Week 8 Rate Ratio vs. Mirabegron.p-value: 0.2195% CI: [0.64, 1.1]Poisson regression
Comparison: Week 12 Rate Ratio vs. Mirabegron.p-value: 0.8395% CI: [0.71, 1.32]Poisson regression
Comparison: Final Visit Rate Ratio vs. Mirabegronp-value: 0.5795% CI: [0.68, 1.24]Poisson regression
Secondary

Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

A nocturia episode is defined as waking at night ≥1 times to void (i.e., any voiding associated with sleep disturbance between the time the patient goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The total number of nocturia episodes were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. Only participants with at least one nocturia episode at baseline were included in the analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (MEAN)Dispersion
Mirabegron 50 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=877,871]4.78 nocturia episodesStandard Error 0.12
Mirabegron 50 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=850, 844]4.26 nocturia episodesStandard Error 0.118
Mirabegron 50 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=831,828]3.94 nocturia episodesStandard Error 0.115
Mirabegron 50 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal Visit [N=879,875]4.05 nocturia episodesStandard Error 0.12
Solifenacin 5 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal Visit [N=879,875]4.13 nocturia episodesStandard Error 0.114
Solifenacin 5 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=877,871]5.12 nocturia episodesStandard Error 0.139
Solifenacin 5 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=831,828]4.06 nocturia episodesStandard Error 0.116
Solifenacin 5 mgNumber of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=850, 844]4.41 nocturia episodesStandard Error 0.117
Comparison: Week 4 Rate Ratio vs. Mirabegronp-value: 0.06895% CI: [1, 1.11]Poisson regression
Comparison: Week 8 Rate Ratio vs. Mirabegronp-value: 0.2195% CI: [0.98, 1.11]Poisson regression
Comparison: Week 12 Rate Ratio vs. Mirabegronp-value: 0.5295% CI: [0.95, 1.1]Poisson regression
Comparison: Final Visit Rate Ratio vs. Mirabegronp-value: 0.4495% CI: [0.96, 1.1]Poisson regression
Secondary

Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit

The total number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS population. LOCF was used in final visit only. Only participants with at least one pad used at baseline were included in this analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (MEAN)Dispersion
Mirabegron 50 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=574,563]4.25 padsStandard Error 0.324
Mirabegron 50 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=551,543]3.33 padsStandard Error 0.284
Mirabegron 50 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=543,532]3.19 padsStandard Error 0.304
Mirabegron 50 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=576,565]3.32 padsStandard Error 0.3
Solifenacin 5 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=576,565]3.19 padsStandard Error 0.248
Solifenacin 5 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=574,563]4.26 padsStandard Error 0.297
Solifenacin 5 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=543,532]3.04 padsStandard Error 0.244
Solifenacin 5 mgNumber of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=551,543]3.27 padsStandard Error 0.236
Comparison: Week 4 Rate Ratio vs. Mirabegronp-value: 0.6795% CI: [0.89, 1.2]Poisson regression
Comparison: Week 8 Rate Ratio vs. Mirabegronp-value: 0.07395% CI: [0.99, 1.39]Poisson regression
Comparison: Week 12 Rate Ratio vs. Mirabegronp-value: 0.2595% CI: [0.92, 1.37]Poisson regression
Comparison: Final Visit Rate Ratio vs. Mirabegronp-value: 0.495% CI: [0.9, 1.31]Poisson regression
Secondary

Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit

An urgency incontinence episode is any involuntary leakage of urine accompanied by or immediately proceeded by urgency. The total number of urgency incontinence episodes per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period prior to each visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS-I population. LOCF was used for final visit only. Only participants with at least one urgency incontinence episode at baseline were included in the analysis. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (MEAN)Dispersion
Mirabegron 50 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=395,399]2.27 urgency incontinence episodesStandard Error 0.23
Mirabegron 50 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=379,386]1.74 urgency incontinence episodesStandard Error 0.227
Mirabegron 50 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=373,377]1.44 urgency incontinence episodesStandard Error 0.217
Mirabegron 50 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=395,402]1.51 urgency incontinence episodesStandard Error 0.211
Solifenacin 5 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitFinal visit [N=395,402]1.23 urgency incontinence episodesStandard Error 0.15
Solifenacin 5 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 4 [N=395,399]2.16 urgency incontinence episodesStandard Error 0.213
Solifenacin 5 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 12 [N=373,377]1.03 urgency incontinence episodesStandard Error 0.12
Solifenacin 5 mgNumber of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final VisitWeek 8 [N=379,386]1.13 urgency incontinence episodesStandard Error 0.125
Comparison: Week 4 Rate Ratio vs. Mirabegronp-value: 0.4495% CI: [0.74, 1.14]Poisson regression
Comparison: Week 8 Rate Ratio vs. Mirabegronp-value: 0.1195% CI: [0.6, 1.06]Poisson regression
Comparison: Week 12 Rate Ratio vs. Mirabegronp-value: 0.7895% CI: [0.76, 1.45]Poisson regression
Comparison: Final Visit Rate Ratio vs. Mirabegronp-value: 0.8595% CI: [0.71, 1.33]Poisson regression
Secondary

Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period

A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE; defined as any untoward medical occurrence in a patient administered a study drug) that started or worsened in the period from the first double-blind medication intake until 30 days after the last double-blind medication intake. The following TEAEs were selected for inclusion in the analysis: Dry mouth (aptyalism, dry mouth, dry throat), constipation (constipation), blurred vision (vision blurred, myopia, refraction disorder, accommodation disorder).

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

Population: SAF population

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodDry mouth3.1 percentage of participants
Mirabegron 50 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodBlurred vision0.6 percentage of participants
Mirabegron 50 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodDry throat0.1 percentage of participants
Mirabegron 50 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodConstipation2.2 percentage of participants
Mirabegron 50 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodOverall5 percentage of participants
Solifenacin 5 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodConstipation2.5 percentage of participants
Solifenacin 5 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodOverall7.4 percentage of participants
Solifenacin 5 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodDry mouth5.8 percentage of participants
Solifenacin 5 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodDry throat0.1 percentage of participants
Solifenacin 5 mgPercentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment PeriodBlurred vision0.4 percentage of participants
Comparison: Difference vs Mirabegron. Differences of the percentages were calculated by subtracting the percentage of mirabegron 50 mg group from the percentage of solifenacin 5 mg group.p-value: 0.0395% CI: [1.04, 2.25]Regression, Logistic
Secondary

Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant with at least 50% decrease from baseline in mean number of incontinence episodes per 24 hours during the treatment period at specified visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4 [N=404,410]75.5 percentage of participants
Mirabegron 50 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 8 [N=387,397]85.5 percentage of participants
Mirabegron 50 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 12 [N=381,387]86.1 percentage of participants
Mirabegron 50 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitFinal visit [N=404,413]85.1 percentage of participants
Solifenacin 5 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitFinal visit [N=404,413]88.1 percentage of participants
Solifenacin 5 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4 [N=404,410]77.3 percentage of participants
Solifenacin 5 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 12 [N=381,387]89.1 percentage of participants
Solifenacin 5 mgPercentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 8 [N=387,397]86.9 percentage of participants
Comparison: Week 4 Odds Ratio vs. Mirabegronp-value: 0.7495% CI: [0.76, 1.48]Regression, Logistic
Comparison: Week 8 Odds Ratio vs. Mirabegronp-value: 0.7495% CI: [0.71, 1.63]Regression, Logistic
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.2995% CI: [0.81, 2]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.2995% CI: [0.82, 1.9]Regression, Logistic
Secondary

Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with \>=10 points improvement in the total HRQL score from baseline.

Time frame: Baseline to Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final VisitWeek 12 [N=865,859]69.2 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final VisitFinal visit [N=906,897]67.5 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final VisitWeek 12 [N=865,859]72.6 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final VisitFinal visit [N=906,897]71.0 percentage of participants
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.03795% CI: [1.02, 1.62]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.04595% CI: [1.01, 1.57]Regression, Logistic
Secondary

Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥1 point improvement in PPBC from baseline.

Time frame: Baseline to Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final VisitWeek 12 [N=865,858]73.1 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final VisitFinal visit [N=906,897]71.9 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final VisitWeek 12 [N=865,858]76.7 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final VisitFinal visit [N=906,897]74.9 percentage of participants
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.08295% CI: [0.97, 1.57]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.1595% CI: [0.94, 1.49]Regression, Logistic
Secondary

Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit

A responder is defined as a participant with ≥10 points improvement in symptom bother from baseline.

Time frame: Baseline to Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final VisitWeek 12 [N=865,859]77.5 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final VisitFinal visit [N=906,897]76.2 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final VisitWeek 12 [N=865,859]82.4 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final VisitFinal visit [N=906,897]81.2 percentage of participants
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.0195% CI: [1.08, 1.81]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.01195% CI: [1.07, 1.75]Regression, Logistic
Secondary

Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit

A responder is defined as a participant with \>=1 or \>=2 or \>=3 or \>=4 or \>=5 or 6-point improvement from baseline in TS-Likert scale.

Time frame: Baseline to final visit (up to Week 12)

Population: FAS population. LOCF was used.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥1 point improvement85.6 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥2 point improvement79.0 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥3 point improvement66.7 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥4 point improvement43.8 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥5 point improvement15.4 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit6 point improvement2.5 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥5 point improvement15.1 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥1 point improvement89.4 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥4 point improvement46.6 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥2 point improvement82.6 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit6 point improvement2.8 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit≥3 point improvement70.8 percentage of participants
Comparison: Final visit (≥1 point improvement) Odds Rato vs. Mirabegronp-value: 0.01695% CI: [1.07, 1.93]Regression, Logistic
Comparison: Final visit (≥2 point improvement) Odds Rato vs. Mirabegronp-value: 0.06395% CI: [0.99, 1.62]Regression, Logistic
Comparison: Final visit (≥3 point improvement) Odds Rato vs. Mirabegronp-value: 0.05495% CI: [1, 1.53]Regression, Logistic
Comparison: Final visit (≥4 point improvement) Odds Rato vs. Mirabegronp-value: 0.1595% CI: [0.95, 1.46]Regression, Logistic
Comparison: Final visit (≥5 point improvement) Odds Rato vs. Mirabegronp-value: 0.7595% CI: [0.77, 1.44]Regression, Logistic
Comparison: Final visit (6 point improvement) Odds Rato vs. Mirabegronp-value: 0.6695% CI: [0.64, 2.04]Regression, Logistic
Secondary

Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12

A responder is defined as a participant with ≥1, ≥2, ≥3, ≥4, ≥5 or 6-point improvement from baseline in TS-Likert scale.

Time frame: Baseline to Week 12

Population: FAS population.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥4 point improvement44.4 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥2 point improvement80.3 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥3 point improvement67.7 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥5 point improvement15.6 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 126 point improvement2.5 percentage of participants
Mirabegron 50 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥1 point improvement86.4 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 126 point improvement2.9 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥1 point improvement90.4 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥5 point improvement15.4 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥2 point improvement83.6 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥3 point improvement71.9 percentage of participants
Solifenacin 5 mgPercentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12≥4 point improvement47.5 percentage of participants
Comparison: Week 12 (≥1 point improvement) Odds Rato vs. Mirabegronp-value: 0.00995% CI: [1.11, 2.06]Regression, Logistic
Comparison: Week 12 (≥2 point improvement) Odds Rato vs. Mirabegronp-value: 0.06595% CI: [0.99, 1.65]Regression, Logistic
Comparison: Week 12 (≥3 point improvement) Odds Rato vs. Mirabegronp-value: 0.05195% CI: [1, 1.55]Regression, Logistic
Comparison: Week 12 (≥4 point improvement) Odds Rato vs. Mirabegronp-value: 0.1495% CI: [0.95, 1.47]Regression, Logistic
Comparison: Week 12 (≥5 point improvement) Odds Rato vs. Mirabegronp-value: 0.8995% CI: [0.75, 1.4]Regression, Logistic
Comparison: Week 12 (6 point improvement) Odds Rato vs. Mirabegronp-value: 0.6695% CI: [0.64, 2.04]Regression, Logistic
Secondary

Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit

A responder is defined as a participant with ≥2 point improvement in PPBC from baseline.

Time frame: Baseline to Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final VisitWeek 12 [N=865,858]47.6 percentage of participants
Mirabegron 50 mgPercentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final VisitFinal visit [N=906,897]46.2 percentage of participants
Solifenacin 5 mgPercentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final VisitWeek 12 [N=865,858]52.6 percentage of participants
Solifenacin 5 mgPercentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final VisitFinal visit [N=906,897]51.1 percentage of participants
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.05895% CI: [0.99, 1.53]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.06995% CI: [0.99, 1.5]Regression, Logistic
Secondary

Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who has ≥8 micturitions at baseline and has \<8 micturitions per 24 hours during the treatment period at each specified visit, where change from baseline is \<0.

Time frame: Week 4, Week 8, Week 12

Population: FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 4 [N=916,906]32.3 percentage of participants
Mirabegron 50 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 8 [N=888,876]41.2 percentage of participants
Mirabegron 50 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 12 [N=870,856]44.8 percentage of participants
Mirabegron 50 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitFinal visit [N=920,910]44.2 percentage of participants
Solifenacin 5 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitFinal visit [N=920,910]48.8 percentage of participants
Solifenacin 5 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 4 [N=916,906]33.9 percentage of participants
Solifenacin 5 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 12 [N=870,856]49.3 percentage of participants
Solifenacin 5 mgPercentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final VisitWeek 8 [N=888,876]46.9 percentage of participants
Comparison: Week 4 Odds ratio vs. Mirabegronp-value: 0.6795% CI: [0.85, 1.28]Regression, Logistic
Comparison: Week 8 Odds ratio vs. Mirabegronp-value: 0.02695% CI: [1.03, 1.53]Regression, Logistic
Comparison: Week 12 Odds ratio vs. Mirabegronp-value: 0.1195% CI: [0.97, 1.44]Regression, Logistic
Comparison: Final Visit Odds ratio vs. Mirabegronp-value: 0.09395% CI: [0.97, 1.43]Regression, Logistic
Secondary

Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit

A responder is defined as a participant who reported incontinence episodes at baseline and reported no incontinence episodes during the treatment period at specified visit.

Time frame: Week 4, Week 8, Week 12

Population: FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.

ArmMeasureGroupValue (NUMBER)
Mirabegron 50 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4 [N=404,410]47.3 percentage of participants
Mirabegron 50 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 8 [N=387,397]64.3 percentage of participants
Mirabegron 50 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 12 [N=381,387]69.0 percentage of participants
Mirabegron 50 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitFinal visit [N=404,413]67.3 percentage of participants
Solifenacin 5 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitFinal visit [N=404,413]68.5 percentage of participants
Solifenacin 5 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 4 [N=404,410]52.0 percentage of participants
Solifenacin 5 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 12 [N=381,387]69.5 percentage of participants
Solifenacin 5 mgPercentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final VisitWeek 8 [N=387,397]63.2 percentage of participants
Comparison: Week 4 Odds Ratio vs. Mirabegronp-value: 0.295% CI: [0.9, 1.67]Regression, Logistic
Comparison: Week 8 Odds Ratio vs. Mirabegronp-value: 0.5795% CI: [0.65, 1.26]Regression, Logistic
Comparison: Week 12 Odds Ratio vs. Mirabegronp-value: 0.9295% CI: [0.69, 1.39]Regression, Logistic
Comparison: Final visit Odds Ratio vs. Mirabegronp-value: 0.995% CI: [0.73, 1.42]Regression, Logistic

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