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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. (BEYOND)

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ClinicalTrials.gov Identifier: NCT01638000
Recruitment Status : Completed
First Posted : July 11, 2012
Results First Posted : August 30, 2016
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe Ltd. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Urologic Diseases
Urinary Bladder, Overactive
Urinary Bladder Diseases
Interventions Drug: Mirabegron
Drug: Solifenacin succinate
Enrollment 1887
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description Participants who received mirabegron 50 mg once daily for 12 weeks. Participants who received solifenacin 5 mg once daily for 12 weeks.
Period Title: Overall Study
Started 943 944
Received at Least 1 Double-Blind Dose 936 934
Completed 883 873
Not Completed 60 71
Reason Not Completed
Randomized but Never Received Drug             7             10
Adverse Event             14             16
Lack of Efficacy             5             6
Protocol Violation             11             13
Withdrawal by Subject             21             24
Miscellaneous             2             2
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Total
Hide Arm/Group Description Participants who received mirabegron 50 mg once daily for 12 weeks. Participants who received solifenacin 5 mg once daily for 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 936 934 1870
Hide Baseline Analysis Population Description
Safety Analysis Set (SAF) - consisted of all randomized patients who received ≥ 1 dose of double-blind study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 936 participants 934 participants 1870 participants
56.7  (14.25) 57.4  (13.60) 57.0  (13.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 936 participants 934 participants 1870 participants
Female
712
  76.1%
709
  75.9%
1421
  76.0%
Male
224
  23.9%
225
  24.1%
449
  24.0%
Mean Micturitions / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Micturitions
Number Analyzed 936 participants 934 participants 1870 participants
11.6  (3.25) 11.4  (2.89) 11.5  (3.08)
[1]
Measure Description: SAF population. The number of participants are 933 and 932. 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.
Mean Incontinence Episodes / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Incontinence episodes
Number Analyzed 936 participants 934 participants 1870 participants
2.1  (2.30) 2.1  (2.05) 2.1  (2.17)
[1]
Measure Description: SAF population with baseline value > 0. The number of participants are 410 and 424. 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.
Mean Urgency Incontinence Episodes / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Urgency incontinence episodes
Number Analyzed 936 participants 934 participants 1870 participants
1.9  (1.99) 2.0  (1.94) 2.0  (1.96)
[1]
Measure Description: SAF population with baseline value > 0. The number of participants are 401 and 413. 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.
Mean Urgency Episodes (grade 3 or 4) / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Urgency episodes
Number Analyzed 936 participants 934 participants 1870 participants
7.7  (4.75) 7.8  (4.46) 7.8  (4.61)
[1]
Measure Description: SAF population with baseline value > 0. The number of participants are 931 and 931. 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.
Mean Level of Urgency   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 936 participants 934 participants 1870 participants
2.6  (0.49) 2.6  (0.49) 2.6  (0.49)
[1]
Measure Description: SAF population. The number of participants are 933 and 932. 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.
Mean Nocturia Episodes / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Nocturia episodes
Number Analyzed 936 participants 934 participants 1870 participants
2.3  (1.41) 2.3  (1.42) 2.3  (1.41)
[1]
Measure Description: SAF population with baseline value > 0. The number of participants are 890 and 895. 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.
Mean Number of Pads Used / 24 hours   [1] 
Mean (Standard Deviation)
Unit of measure:  Pads
Number Analyzed 936 participants 934 participants 1870 participants
3.1  (3.43) 3.3  (3.70) 3.2  (3.57)
[1]
Measure Description: SAF population with baseline value > 0. The number of participants are 585 and 580. The mean number of pads per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
1.Primary Outcome
Title Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 853
Least Squares Mean (Standard Error)
Unit of Measure: micturitions
-2.95  (0.087) -3.13  (0.088)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments The non-inferiority of mirabegron vs. solifencacin on the change from baseline to final visit in the mean number of micturitions per 24 hours.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority was concluded if the lower limit of the 95% CI for difference of adjusted change from baseline between solifenacin 5 mg and mirabegron 50 mg was > -0.20. Differences of adjusted means were calculated by subtracting the adjusted mean of mirabegron 50 mg from the adjusted mean of solifenacin 5 mg. Overall power calculation was 80% for a 1-sided test and significance level of 0.025.
Statistical Test of Hypothesis P-Value 0.15
Comments If p<0.05, this indicated superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.18
Confidence Interval (2-Sided) 95%
-0.42 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.124
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
SAF population
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 936 934
Measure Type: Number
Unit of Measure: percentage of participants
Overall 5 7.4
Dry mouth 3.1 5.8
Dry throat 0.1 0.1
Blurred vision 0.6 0.4
Constipation 2.2 2.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.030
Comments If P <0.05, this indicates superiority in favor of the treatment group with the smallest percentage of participants with at least 1 TEAE of dry mouth, constipation or blurred vision during the double-blind period at the final visit.
Method Regression, Logistic
Comments Included treatment group, sex, age group (< 65, ≥ 65), number of prior antimuscarinics (1, ≥ 2) and geographic region as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.53
Confidence Interval (2-Sided) 95%
1.04 to 2.25
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours
Hide Description [Not Specified]
Time Frame Baseline and Week 4, Week 8, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Least Squares Mean (Standard Error)
Unit of Measure: micturitions
Week 4 [N=916,906] -2.37  (0.083) -2.33  (0.083)
Week 8 [N=888,876] -2.77  (0.084) -3.00  (0.085)
Week 12 [N=870,856] -3.02  (0.088) -3.21  (0.089)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value 0.04
Confidence Interval (2-Sided) 95%
-0.19 to 0.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.117
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.47 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.119
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter least squares mean difference
Estimated Value -0.20
Confidence Interval (2-Sided) 95%
-0.44 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.125
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Mean (Standard Error)
Unit of Measure: incontinence episodes
Week 4 [N=404,410] 2.64  (0.280) 2.25  (0.217)
Week 8 [N=387,397] 2.19  (0.457) 1.28  (0.135)
Week 12 [N=381,387] 2.07  (0.562) 1.08  (0.124)
Final visit [N=404,413] 2.13  (0.533) 1.29  (0.157)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Rate Ratio vs. Mirabegron.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.73 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Rate Ratio vs. Mirabegron.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.64 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Rate Ratio vs. Mirabegron.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.83
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.71 to 1.32
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final Visit Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.68 to 1.24
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-I population. N is the number of participants with available data at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Least Squares Mean (Standard Error)
Unit of Measure: incontinence episodes
Week 4 [N=404,410] -1.22  (0.063) -1.30  (0.063)
Week 8 [N=387,397] -1.37  (0.093) -1.59  (0.092)
Week 12 [N=381,387] -1.41  (0.115) -1.66  (0.114)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.25 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.089
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From the stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.22
Confidence Interval (2-Sided) 95%
-0.48 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.130
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From the stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.25
Confidence Interval (2-Sided) 95%
-0.57 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Mean (Standard Error)
Unit of Measure: urgency incontinence episodes
Week 4 [N=395,399] 2.27  (0.230) 2.16  (0.213)
Week 8 [N=379,386] 1.74  (0.227) 1.13  (0.125)
Week 12 [N=373,377] 1.44  (0.217) 1.03  (0.120)
Final visit [N=395,402] 1.51  (0.211) 1.23  (0.150)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.74 to 1.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.60 to 1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.76 to 1.45
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final Visit Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.71 to 1.33
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Least Squares Mean (Standard Error)
Unit of Measure: urgency incontinence episodes
Week 4 [N=395,399] -1.22  (0.057) -1.24  (0.057)
Week 8 [N=379,386] -1.39  (0.050) -1.56  (0.050)
Week 12 [N=373,377] -1.49  (0.047) -1.59  (0.047)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.18 to 0.14
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.081
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From the stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.17
Confidence Interval (2-Sided) 95%
-0.31 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.070
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments From the stratified rank ANCOVA analysis.
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.11
Confidence Interval (2-Sided) 95%
-0.24 to 0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.066
Estimation Comments [Not Specified]
8.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Least Squares Mean (Standard Error)
Unit of Measure: urgency episodes
Week 4 [N=915,905] -3.75  (0.113) -3.88  (0.114)
Week 8 [N=887,875] -4.44  (0.111) -4.79  (0.112)
Week 12 [N=869,855] -4.67  (0.116) -4.99  (0.117)
Final Visit [N=919,909] -4.61  (0.115) -4.84  (0.115)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.44 to 0.19
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.160
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.027
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.35
Confidence Interval (2-Sided) 95%
-0.66 to -0.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.157
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
Comments [Not Specified]
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.32
Confidence Interval (2-Sided) 95%
-0.64 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.164
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.23
Confidence Interval (2-Sided) 95%
-0.55 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.163
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. LOCF was used in final visit only. N is the number of participants with available data at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 4 [N=916,906] -0.36  (0.016) -0.36  (0.017)
Week 8 [N=888,876] -0.50  (0.019) -0.52  (0.019)
Week 12 [N=870,856] -0.60  (0.023) -0.60  (0.023)
Final visit [N=920,910] -0.58  (0.022) -0.57  (0.022)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.00
Confidence Interval (2-Sided) 95%
-0.05 to 0.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.023
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.07 to 0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.027
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.00
Confidence Interval (2-Sided) 95%
-0.06 to 0.06
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.032
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.05 to 0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.031
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Mean (Standard Error)
Unit of Measure: pads
Week 4 [N=574,563] 4.25  (0.324) 4.26  (0.297)
Week 8 [N=551,543] 3.33  (0.284) 3.27  (0.236)
Week 12 [N=543,532] 3.19  (0.304) 3.04  (0.244)
Final visit [N=576,565] 3.32  (0.300) 3.19  (0.248)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.89 to 1.20
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
0.99 to 1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.92 to 1.37
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final Visit Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.90 to 1.31
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Least Squares Mean (Standard Error)
Unit of Measure: pads
Week 4 [M=574,563] -1.80  (0.081) -1.82  (0.081)
Week 8 [N=551,543] -2.10  (0.070) -2.14  (0.070)
Week 12 [N=543,532] -2.14  (0.078) -2.20  (0.079)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 95%
-0.25 to 0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.115
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 95%
-0.24 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.099
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments if p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 95%
-0.28 to 0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.111
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Mean (Standard Error)
Unit of Measure: nocturia episodes
Week 4 [N=877,871] 4.78  (0.120) 5.12  (0.139)
Week 8 [N=850, 844] 4.26  (0.118) 4.41  (0.117)
Week 12 [N=831,828] 3.94  (0.115) 4.06  (0.116)
Final Visit [N=879,875] 4.05  (0.120) 4.13  (0.114)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
1.00 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.04
Confidence Interval (2-Sided) 95%
0.98 to 1.11
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.95 to 1.10
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final Visit Rate Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method Poisson regression
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region and baseline as covariates.
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.96 to 1.10
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Least Squares Mean (Standard Error)
Unit of Measure: nocturia episodes
Week 4 [N=877,871] -0.72  (0.033) -0.63  (0.034)
Week 8 [N=850,844] -0.90  (0.031) -0.87  (0.031)
Week 12 [N=831,828] -0.98  (0.032) -0.97  (0.033)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.00 to 0.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.047
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.06 to 0.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.044
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest improvement at specified visit.
Method ANCOVA
Comments Treatment group, gender, age group (<65, ≥65), number of prior antimuscarinics (1, ≥2), geographic region as fixed factors and baseline as a covariate
Method of Estimation Estimation Parameter Least squares mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 95%
-0.08 to 0.10
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.046
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population. LOCF was used for final visit only. N is the number of participants with available data at each timepoint.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 921 912
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 [N=916,906] 32.3 33.9
Week 8 [N=888,876] 41.2 46.9
Week 12 [N=870,856] 44.8 49.3
Final visit [N=920,910] 44.2 48.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Odds ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.67
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.85 to 1.28
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Odds ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
1.03 to 1.53
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Odds ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.97 to 1.44
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final Visit Odds ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.97 to 1.43
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 [N=404,410] 75.5 77.3
Week 8 [N=387,397] 85.5 86.9
Week 12 [N=381,387] 86.1 89.1
Final visit [N=404,413] 85.1 88.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.06
Confidence Interval (2-Sided) 95%
0.76 to 1.48
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.07
Confidence Interval (2-Sided) 95%
0.71 to 1.63
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.27
Confidence Interval (2-Sided) 95%
0.81 to 2.00
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final visit Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.25
Confidence Interval (2-Sided) 95%
0.82 to 1.90
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS-I population. LOCF was used for final visit only. N is the number of participants with available data at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 405 413
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 [N=404,410] 47.3 52.0
Week 8 [N=387,397] 64.3 63.2
Week 12 [N=381,387] 69.0 69.5
Final visit [N=404,413] 67.3 68.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 4 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.20
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.90 to 1.67
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 8 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.91
Confidence Interval (2-Sided) 95%
0.65 to 1.26
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Week 12 Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.69 to 1.39
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg
Comments Final visit Odds Ratio vs. Mirabegron
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments If p<0.05, this indicates superiority in favor of the treatment group with the largest percentage of responders at specified visit.
Method Regression, Logistic
Comments Treatment group, gender, age group (<65,≥ 65), number of prior antimuscarinics (1, ≥2), geographic region and baseline value as factors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.73 to 1.42
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who have non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 905 896
Measure Type: Number
Unit of Measure: participants
No problems -> No problems 447 443
No problems -> Slight problems 45 43
No problems -> Moderate problems 23 19
No problems -> Severe problems 2 6
No problems -> Extreme problems 0 1
No problems -> no data 4 3
Slight problems -> no problems 66 80
Slight problems -> slight problems 47 47
Slight problems -> moderate problems 24 11
Slight problems -> severe problems 6 3
Slight problems -> extreme problems 0 1
Slight problems -> no data 1 1
Moderate problems -> no problems 39 51
Moderate problems -> slight problems 39 45
Moderate problems -> moderate problems 50 46
Moderate problems -> severe problems 7 6
Moderate problems -> extreme problems 1 0
Moderate problems -> no data 0 1
Severe problems -> no problems 20 16
Severe problems -> slight problems 24 34
Severe problems -> moderate problems 45 29
Severe problems -> severe problems 16 12
Severe problems -> extreme problems 1 0
Severe problems -> no data 0 2
Extreme problems -> no problems 2 1
Extreme problems -> slight problems 1 1
Extreme problems -> moderate problems 0 0
Extreme problems -> severe problems 0 0
Extreme problems -> extreme problems 0 1
Extreme problems -> no data 0 0
No data -> no problems 1 1
No data -> slight problems 1 1
No data -> moderate problems 1 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 8 7
18.Secondary Outcome
Title Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 905 896
Measure Type: Number
Unit of Measure: participants
No problems -> No problems 693 703
No problems -> slight problems 26 23
No problems -> moderate problems 12 4
No problems -> severe problems 0 0
No problems -> extreme problems 0 1
No problems -> no data 5 5
Slight problems -> No problems 37 41
Slight problems -> slight problems 28 16
Slight problems -> moderate problems 8 5
Slight problems -> severe problems 1 2
Slight problems -> extreme problems 0 0
Slight problems -> no data 0 0
Moderate problems -> no problems 24 17
Moderate problems -> slight problems 18 28
Moderate problems -> moderate problems 17 15
Moderate problems -> severe problems 1 0
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 0 0
Severe problems -> no problems 9 15
Severe problems -> slight problems 13 15
Severe problems -> moderate problems 7 6
Severe problems -> severe problems 4 0
Severe problems -> extreme problems 0 1
Severe problems -> no data 0 1
Extreme problems -> no problems 4 1
Extreme problems -> slight problems 1 1
Extreme problems -> moderate problems 1 0
Extreme problems -> severe problems 0 2
Extreme problems -> extreme problems 1 0
Extreme problems -> no data 0 1
No data -> no problems 1 2
No data -> slight problems 1 0
No data -> moderate problems 1 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 8 7
19.Secondary Outcome
Title Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 905 896
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 421 422
No problems -> slight problems 61 63
No problems -> moderate problems 20 10
No problems -> severe problems 4 3
No problems -> extreme problems 1 0
No problems -> no data 4 4
Slight problems -> no problems 102 101
Slight problems -> slight problems 49 58
Slight problems -> moderate problems 14 16
Slight problems -> severe problems 2 1
Slight problems -> extreme problems 1 1
Slight problems -> no data 1 0
Moderate problems -> no problems 47 34
Moderate problems -> slight problems 59 59
Moderate problems -> moderate problems 45 39
Moderate problems -> severe problems 9 7
Moderate problems -> extreme problems 1 0
Moderate problems -> no data 0 0
Severe problems -> no problems 17 28
Severe problems -> slight problems 21 19
Severe problems -> moderate problems 11 13
Severe problems -> severe problems 7 7
Severe problems -> extreme problems 1 1
Severe problems -> no data 0 3
Extreme problems -> no problems 0 4
Extreme problems -> slight problems 3 5
Extreme problems -> moderate problems 5 3
Extreme problems -> severe problems 3 1
Extreme problems -> extreme problems 1 1
Extreme problems -> no data 0 0
No data -> no problems 0 2
No data -> slight problems 2 0
No data -> moderate problems 1 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 8 7
20.Secondary Outcome
Title Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 905 896
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 299 285
No problems -> slight problems 57 67
No problems -> moderate problems 11 17
No problems -> severe problems 1 5
No problems -> extreme problems 1 0
No problems -> no data 2 4
Slight problems -> no problems 101 97
Slight problems -> slight problems 116 109
Slight problems -> moderate problems 32 25
Slight problems -> severe problems 2 4
Slight problems -> extreme problems 0 0
Slight problems -> no data 1 0
Moderate problems -> no problems 51 44
Moderate problems -> slight problems 60 86
Moderate problems -> moderate problems 66 65
Moderate problems -> severe problems 10 12
Moderate problems -> extrme problems 1 1
Moderate problems -> no data 2 1
Severe problems -> no problems 21 19
Severe problems -> slight problems 22 25
Severe problems -> moderate problems 19 17
Severe problems -> severe problems 20 6
Severe problems -> extreme problems 6 0
Severe problems -> no data 0 1
Extreme problems -> no problems 1 1
Extreme problems -> slight problems 2 6
Extreme problems -> moderate problems 3 3
Extreme problems -> severe problems 1 2
Extreme problems -> extreme problems 2 0
Extreme problems -> no data 0 1
No data -> no problems 1 1
No data -> slight problems 0 1
No data -> moderate problems 2 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 8 7
21.Secondary Outcome
Title Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 905 896
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 328 339
No problems -> slight problems 59 65
No problems -> moderate problems 11 11
No problems -> severe problems 2 2
No problems -> extreme problems 0 2
No problems -> no data 4 2
Slight problems -> no problems 98 102
Slight problems -> slight problems 122 94
Slight problems -> moderate problems 29 25
Slight problems -> severe problems 5 3
Slight problems -> extreme problems 1 0
Slight problems -> no data 0 0
Moderate problems -> no problems 25 33
Moderate problems -> slight problems 64 65
Moderate problems -> moderate problems 37 40
Moderate problems -> severe problems 12 10
Moderate problems -> extreme problems 3 1
Moderate problems -> no data 0 2
Severe problems -> no problems 12 17
Severe problems -> slight problems 32 29
Severe problems -> moderate problems 26 19
Severe problems -> severe problems 12 9
Severe problems -> extreme problems 2 0
Severe problems -> no data 1 3
Extreme problems -> no problems 7 12
Extreme problems -> slight problems 8 4
Extreme problems -> moderate problems 3 5
Extreme problems -> severe problems 4 4
Extreme problems -> extreme problems 3 5
Extreme problems -> no data 0 0
No data -> no problems 1 1
No data -> slight problems 2 1
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 8 7
22.Secondary Outcome
Title Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 882 875
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 445 446
No problems -> slight problems 38 31
No problems -> moderate problems 20 23
No problems -> severe problems 3 3
No problems -> extreme problems 1 1
No problems -> no data 14 11
Slight problems -> no problems 70 78
Slight problems -> slight problems 46 44
Slight problems -> moderate problems 19 12
Slight problems -> severe problems 3 3
Slight problems -> extreme problems 0 0
Slight problems -> no data 6 6
Moderate problems -> no problems 51 47
Moderate problems -> slight problems 41 52
Moderate problems -> modrate problems 31 40
Moderate problems -> severe problems 8 6
Moderate problems -> extreme problems 1 0
Moderate problems -> no data 4 4
Severe problems -> no problems 30 22
Severe problems -> slight problems 30 41
Severe problems -> moderate problems 21 15
Severe problems -> severe problems 20 8
Severe problems -> extreme problems 1 0
Severe problems -> no data 4 7
Extreme problems -> no problems 1 0
Extreme problems -> slight problems 1 1
Extreme problems -> moderate problems 1 0
Extreme problems -> severe problems 0 1
Extreme problems -> extreme problems 0 1
Extreme problems -> no data 0 0
No data -> no problems 4 4
No data -> slight problems 3 1
No data -> moderate problems 1 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 3 4
23.Secondary Outcome
Title Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 882 875
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 672 673
No problems -> slight problems 35 38
No problems -> moderate problems 7 2
No problems -> severe problems 1 1
No problems -> extreme problems 1 1
No problems -> no data 20 21
Slight problems -> no problems 42 33
Slight problems -> slight problems 19 20
Slight problems -> moderate problems 9 9
Slight problems -> severe problems 1 0
Slight problems -> exteme problems 0 0
Slight problems -> no data 3 2
Moderate problems -> no problems 34 34
Moderate problems -> slight problems 17 16
Moderate problems -> moderate problems 5 6
Moderate problems -> severe problems 2 2
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 2 2
Severe problems -> no problems 17 13
Severe problems -> slight problems 9 15
Severe problems -> moderate problems 4 8
Severe problems -> severe problems 2 0
Severe problems -> extreme problems 0 0
Severe problems -> no data 1 2
Extreme problems -> no problems 1 2
Extreme problems -> slight problems 4 2
Extreme problems -> moderate problems 0 0
Extreme problems -> severe problems 0 0
Extreme problems -> extreme problems 0 0
Extreme problems -> no data 2 1
No data -> no problems 6 5
No data -> slight problems 2 0
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 3 4
24.Secondary Outcome
Title Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 882 875
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 430 426
No problems -> slight problems 48 49
No problems -> moderate problems 15 11
No problems -> severe problems 2 3
No problems -> extreme problems 0 0
No problems -> no data 16 13
Slight problems -> no problems 101 109
Slight problems -> slight problems 45 50
Slight problems -> moderate problems 16 12
Slight problems -> severe problems 3 2
Slight problems -> extreme problems 1 0
Slight problems -> no data 3 4
Moderate problems -> no problems 61 53
Moderate problems -> slight problems 57 53
Moderate problems -> moderate problems 26 20
Moderate problems -> severe problems 10 6
Moderate problems -> extreme problems 1 1
Moderate problems -> no data 6 6
Severe problems -> no problems 13 16
Severe problems -> slight problems 23 32
Severe problems -> moderate problems 12 15
Severe problems -> severe problems 7 3
Severe problems -> extreme problems 0 0
Severe problems -> no data 2 5
Extreme problems -> no problems 5 4
Extreme problems -> slight problems 2 5
Extreme problems -> moderate problems 2 3
Extreme problems -> severe problems 2 0
Extreme problems -> extreme problems 0 2
Extreme problems -> no data 1 0
No data -> no problems 3 4
No data -> slight problems 5 1
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 3 4
25.Secondary Outcome
Title Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 882 875
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 291 286
No problems -> slight problems 52 66
No problems -> moderate problems 13 16
No problems -> severe problems 4 0
No problems -> extreme problems 1 0
No problems -> no data 10 10
Slight problems -> no problems 103 96
Slight problems -> slight problems 111 103
Slight problems -> moderate problems 25 30
Slight problems -> severe problems 6 1
Slight problems -> extreme problems 0 0
Slight problems -> no data 7 5
Moderate problems -> no problems 59 61
Moderate problems -> slight problems 66 78
Moderate problems -> moderate problems 46 57
Moderate problems -> severe problems 10 4
Moderate problems -> extreme problems 1 1
Moderate problems -> no data 8 8
Severe problems -> no problems 17 16
Severe problems -> slight problems 37 25
Severe problems -> moderate problems 12 15
Severe problems -> severe problems 18 7
Severe problems -> extreme problems 2 1
Severe problems -> no data 2 4
Extreme problems -> no problems 1 3
Extreme problems -> slight problems 4 4
Extreme problems -> moderate problems 2 4
Extreme problems -> severe problems 0 1
Extreme problems -> extreme problems 1 0
Extreme problems -> no data 1 1
No data -> no problems 4 2
No data -> slight problems 4 3
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 3 4
26.Secondary Outcome
Title Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 882 875
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 325 334
No problems -> slight problems 52 65
No problems -> moderate problems 15 8
No problems -> severe problems 2 1
No problems -> extreme problems 0 0
No problems -> no data 10 13
Slight problems -> no problems 122 116
Slight problems -> slight problems 94 79
Slight problems -> moderate problems 26 20
Slight problems -> severe problems 4 3
Slight problems -> extreme problems 3 2
Slight problems -> no data 6 4
Moderate problems -> no problems 42 49
Moderate problems -> slight problems 50 59
Moderate problems -> moderate problems 31 34
Moderate problems -> severe problems 11 4
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 7 5
Severe problems -> no problems 23 13
Severe problems -> slight problems 39 37
Severe problems -> moderate problems 11 12
Severe problems -> severe problems 7 6
Severe problems -> extreme problems 1 3
Severe problems -> no data 4 6
Extreme problems -> no problems 9 11
Extreme problems -> slight problems 7 10
Extreme problems -> moderate problems 2 4
Extreme problems -> severe problems 3 1
Extreme problems -> extreme problems 3 4
Extreme problems -> no data 1 0
No data -> no problems 5 2
No data -> slight problems 3 2
No data -> moderate problems 0 1
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 3 4
27.Secondary Outcome
Title Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 857
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 442 459
No problems -> slight problems 36 25
No problems -> moderate problems 10 10
No problems -> severe problems 6 5
No problems -> extreme problems 1 0
No problems -> no data 26 16
Slight problems -> no problems 77 82
Slight problems -> slight problems 43 32
Slight problems -> moderate problems 15 16
Slight problems -> severe problems 2 2
Slight problems -> extreme problems 0 0
Slight problems -> no data 7 11
Moderate problems -> no problems 57 63
Moderate problems -> slight problems 31 43
Moderate problems -> moderate problems 35 30
Moderate problems -> severe problems 7 4
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 6 9
Severe problems -> no problems 53 51
Severe problems -> slight problems 15 17
Severe problems -> moderate problems 15 7
Severe problems -> severe problems 18 8
Severe problems -> extreme problems 0 0
Severe problems -> no data 5 10
Extreme problems -> no problems 2 1
Extreme problems -> slight problems 0 1
Extreme problems -> moderate problems 0 0
Extreme problems -> severe problems 0 0
Extreme problems -> extreme problems 0 1
Extreme problems -> no data 1 0
No data -> no problems 2 9
No data -> slight problems 5 0
No data -> moderate problems 3 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
28.Secondary Outcome
Title Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 857
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 667 670
No problems -> slight problems 26 23
No problems -> moderate problems 5 6
No problems -> severe problems 1 1
No problems -> extreme problems 1 0
No problems -> no data 36 36
Slight problems -> no problems 43 42
Slight problems -> slight problems 13 12
Slight problems -> moderate problems 14 5
Slight problems -> severe problems 1 1
Slight problems -> extreme problems 0 0
Slight problems -> no data 3 4
Moderate problems -> no problems 44 46
Moderate problems -> slight problems 8 6
Moderate problems -> moderate problems 5 6
Moderate problems -> severe problems 1 0
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 2 2
Severe problems -> no problems 25 25
Severe problems -> slight problems 4 7
Severe problems -> moderate problems 0 2
Severe problems -> severe problems 3 1
Severe problems -> extreme problems 0 0
Severe problems -> no data 1 3
Extreme problems -> no problems 4 4
Extreme problems -> slight problems 0 0
Extreme problems -> moderate problems 0 0
Extreme problems -> severe problems 0 0
Extreme problems -> extreme problems 0 0
Extreme problems -> no data 3 1
No data -> no problems 8 9
No data -> slight problems 2 0
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
29.Secondary Outcome
Title Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 857
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 425 426
No problems -> slight problems 43 45
No problems -> moderate problems 14 7
No problems -> severe problems 2 2
No problems -> extreme problems 0 0
No problems -> no data 27 22
Slight problems -> no problems 103 107
Slight problems -> slight problems 45 53
Slight problems -> moderate problems 12 9
Slight problems -> severe problems 3 1
Slight problems -> extreme problems 0 0
Slight problems -> no data 6 7
Moderate problems -> no problems 81 79
Moderate problems -> slight problems 41 31
Moderate problems -> moderate problems 25 15
Moderate problems -> severe problems 6 5
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 8 9
Severe problems -> no problems 31 40
Severe problems -> slight problems 7 13
Severe problems -> moderate problems 6 6
Severe problems -> severe problems 9 5
Severe problems -> extreme problems 1 0
Severe problems -> no data 3 7
Extreme problems -> no problems 7 7
Extreme problems -> slight problems 1 2
Extreme problems -> moderate problems 2 3
Extreme problems -> severe problems 1 1
Extreme problems -> extreme problems 0 0
Extreme problems -> no data 1 1
No data -> no problems 7 8
No data -> slight problems 3 1
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
30.Secondary Outcome
Title Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 857
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 287 299
No problems -> slight problems 50 49
No problems -> moderate problems 15 11
No problems -> severe problems 2 4
No problems -> extreme problems 0 0
No problems -> no data 17 15
Slight problems -> no problems 112 116
Slight problems -> slight problems 97 87
Slight problems -> moderate problems 29 18
Slight problems -> severe problems 2 4
Slight problems -> extreme problems 0 0
Slight problems -> no data 12 10
Moderate problems -> no problems 79 80
Moderate problems -> slight problems 49 71
Moderate problems -> moderate problems 42 38
Moderate problems -> severe problems 10 6
Moderate problems -> extreme problems 0 1
Moderate problems -> no data 10 13
Severe problems -> no problems 39 34
Severe problems -> slight problems 14 13
Severe problems -> moderate problems 16 12
Severe problems -> severe problems 12 1
Severe problems -> extreme problems 2 1
Severe problems -> no data 5 7
Extreme problems -> no problems 4 5
Extreme problems -> slight problems 2 2
Extreme problems -> moderate problems 1 3
Extreme problems -> severe problems 1 1
Extreme problems -> extreme problems 0 1
Extreme problems -> no data 1 1
No data -> no problems 7 5
No data -> slight problems 2 4
No data -> moderate problems 1 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
31.Secondary Outcome
Title Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 865 857
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 323 341
No problems -> slight problems 53 48
No problems -> moderate problems 10 10
No problems -> severe problems 1 2
No problems -> extreme problems 1 0
No problems -> no data 16 20
Slight problems -> no problems 132 118
Slight problems -> slight problems 84 80
Slight problems -> moderate problems 26 15
Slight problems -> severe problems 3 2
Slight problems -> extreme problems 0 0
Slight problems -> no data 10 9
Moderate problems -> no problems 52 67
Moderate problems -> slight problems 51 44
Moderate problems -> moderate problems 18 28
Moderate problems -> severe problems 8 5
Moderate problems -> extreme problems 2 1
Moderate problems -> no data 10 6
Severe problems -> no problems 38 35
Severe problems -> slight problems 25 17
Severe problems -> moderate problems 7 14
Severe problems -> severe problems 9 2
Severe problems -> extreme problems 1 0
Severe problems -> no data 5 9
Extreme problems -> no problems 10 15
Extreme problems -> slight problems 5 2
Extreme problems -> moderate problems 3 7
Extreme problems -> severe problems 2 2
Extreme problems -> extreme problems 1 2
Extreme problems -> no data 4 2
No data -> no problems 9 7
No data -> slight problems 1 2
No data -> moderate problems 0 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
32.Secondary Outcome
Title Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population who has non-missing values at both Baseline and specified visit. LOCF was used.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg
Hide Arm/Group Description:
Participants who received mirabegron 50 mg once daily for 12 weeks.
Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Number of Participants Analyzed 906 897
Measure Type: Number
Unit of Measure: participants
No problems -> no problems 460 471
No problems -> slight problems 37 25
No problems -> moderate problems 14 12
No problems -> severe problems 6 5
No problems -> extreme problems 1 0
No problems -> no data 3 2
Slight problems -> no problems 80 88
Slight problems -> slight problems 45 34
Slight problems -> moderate problems 16 18
Slight problems -> severe problems 2 2
Slight problems -> extreme problems 0 0
Slight problems -> no data 1 1
Moderate problems -> no problems 60 67
Moderate problems -> slight problems 33 46
Moderate problems -> moderate problems 36 31
Moderate problems -> severe problems 7 4
Moderate problems -> extreme problems 0 0
Moderate problems -> no data 0 1
Severe problems -> no problems 53 52
Severe problems -> slight problems 15 17
Severe problems -> moderate problems 17 11
Severe problems -> severe problems 20 11
Severe problems -> extreme problems 1 0
Severe problems -> no data 0 2
Extreme problems -> no problems 2 1
Extreme problems -> slight problems 1 1
Extreme problems -> moderate problems 0 0
Extreme problems -> severe problems 0 0
Extreme problems -> extreme problems 0 1
Extreme problems -> no data 0 0
No data -> no problems 2 9
No data -> slight problems 5 0
No data -> moderate problems 3 0
No data -> severe problems 0 0
No data -> extreme problems 0 0
No data -> no data 1 0
33.Secondary Outcome
Title Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire
Hide Description 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 Ba