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

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ClinicalTrials.gov Identifier: NCT02045862
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : June 6, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Urinary Bladder Overactive
Overactive Bladder
Urgency Incontinence
Urinary Bladder Diseases\Urologic Diseases
Interventions Drug: Solifenacin succinate
Drug: Mirabegron
Drug: Placebo to match solifenacin
Drug: Placebo to match mirabegron
Enrollment 1829
Recruitment Details Participants who had symptoms of “wet” overactive bladder (OAB) (urgency, urinary frequency and urgency incontinence) for ≥ 3 months were enrolled in 251 centers globally. A majority of the participants were recruited from participants who enrolled and completed studies 178-CL-101 (NCT01972841) or 905-EC-012 (NCT01908829).
Pre-assignment Details A total of 2084 participants were screened, 2063 participants received placebo run-in treatment and 1829 participants were randomized into 1 of 3 treatment arms in a 1:1:4 ratio in the 52-week double-blind treatment period. Randomization was stratified by sex, age group (< 65 years, ≥ 65 years) and geographic region.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description Participants received mirabegron 50 mg once a day for 52 weeks. Participants received solifenacin 5 mg once a day for 52 weeks. Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Period Title: Overall Study
Started 306 305 1218
Treated 306 303 1210
Completed 267 265 1092
Not Completed 39 40 126
Reason Not Completed
Death             0             0             1
Miscellaneous             5             0             8
Withdrawal by Patient             18             27             57
Protocol Violation             0             0             6
Lack of Efficacy             8             4             13
Randomized but not Received Study Drug             0             2             8
Adverse Event             7             5             27
Lost to Follow-up             1             2             6
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg Total
Hide Arm/Group Description Participants received mirabegron 50 mg once a day for 52 weeks. Participants received solifenacin 5 mg once a day for 52 weeks. Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks. Total of all reporting groups
Overall Number of Baseline Participants 306 305 1218 1829
Hide Baseline Analysis Population Description
The analysis population was the randomized analysis set (RAS), which comprised of all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
58.8  (12.7) 59.0  (13.3) 58.3  (13.0) 58.5  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
Female
243
  79.4%
245
  80.3%
973
  79.9%
1461
  79.9%
Male
63
  20.6%
60
  19.7%
245
  20.1%
368
  20.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
266
  86.9%
265
  86.9%
1066
  87.5%
1597
  87.3%
Black or African American Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
5
   1.6%
4
   1.3%
27
   2.2%
36
   2.0%
Asian Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
31
  10.1%
33
  10.8%
119
   9.8%
183
  10.0%
Other Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
4
   1.3%
3
   1.0%
6
   0.5%
13
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
15
   4.9%
15
   4.9%
54
   4.4%
84
   4.6%
Not Hispanic or Latino Number Analyzed 306 participants 305 participants 1218 participants 1829 participants
291
  95.1%
290
  95.1%
1164
  95.6%
1745
  95.4%
Mean Number of Incontinence Episodes per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Incontinence episodes/24 hours
Number Analyzed 302 participants 299 participants 1193 participants 1794 participants
3.15  (3.56) 3.10  (3.58) 3.04  (3.17) 3.07  (3.31)
[1]
Measure Description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: Full analysis set (FAS), which consisted of all randomized participants who took ≥ 1 dose of double-blind treatment, reported ≥ 1 micturition in the baseline diary and ≥ 1 micturition postbaseline, reported ≥ 1 incontinence episode in the baseline diary and excluded participants from 2 sites due to protocol noncompliance and data integrity issues.
Mean Number of Micturitions per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Micturitions/24 hours
Number Analyzed 302 participants 299 participants 1193 participants 1794 participants
10.51  (2.41) 10.76  (2.83) 10.55  (2.73) 10.58  (2.70)
[1]
Measure Description: A micturition was defined as any voluntary act of passing urine (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population
Mean Volume Voided per Micturition   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mL
Number Analyzed 302 participants 299 participants 1190 participants 1791 participants
161.00  (60.16) 160.70  (58.49) 159.29  (58.40) 159.82  (58.69)
[1]
Measure Description: The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with available data at baseline
Number of Incontinence Episodes per Week   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Incontinence episodes/week
Number Analyzed 302 participants 299 participants 1193 participants 1794 participants
21.8  (24.8) 21.6  (25.0) 20.9  (21.9) 21.2  (22.9)
[1]
Measure Description: An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes per week was the total number of times a participant recorded an incontinence episode in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population
Mean Number of Urgency Incontinence Episodes per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Urgency incontinence episodes/24 hours
Number Analyzed 302 participants 297 participants 1187 participants 1786 participants
2.86  (3.29) 2.91  (3.49) 2.74  (2.78) 2.79  (3.00)
[1]
Measure Description: An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 urgency incontinence episode at baseline
Number of Urgency Incontinence Episodes per Week   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Urgency incontinence episodes/week
Number Analyzed 302 participants 297 participants 1187 participants 1786 participants
19.8  (22.8) 20.2  (24.5) 18.9  (19.1) 19.3  (20.7)
[1]
Measure Description: An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes per week was the total number of times a participant recorded an urgency incontinence episode in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 urgency incontinence episode at baseline
Mean Number of Urgency Episodes (Grade 3 or 4) per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Urgency episodes/24 hours
Number Analyzed 302 participants 299 participants 1193 participants 1794 participants
6.34  (4.16) 6.63  (4.08) 6.53  (3.69) 6.51  (3.84)
[1]
Measure Description: Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 urgency episode at baseline
Mean Number of Nocturia Episodes per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nocturia episodes/24 hours
Number Analyzed 262 participants 252 participants 1027 participants 1541 participants
1.48  (0.95) 1.58  (0.94) 1.49  (0.94) 1.51  (0.94)
[1]
Measure Description: A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 nocturia episode at baseline
Number of Nocturia Episodes per Week   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Nocturia episodes/week
Number Analyzed 262 participants 252 participants 1027 participants 1541 participants
10.3  (6.6) 11.0  (6.6) 10.4  (6.5) 10.4  (6.5)
[1]
Measure Description: A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes per week was the number of times a participant recorded a nocturia episode in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 nocturia episode at baseline
Mean Number of Pads Used per 24 Hours   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Pads/24 hours
Number Analyzed 201 participants 193 participants 771 participants 1165 participants
2.51  (3.76) 2.77  (3.15) 2.58  (2.59) 2.60  (2.91)
[1]
Measure Description: The mean number of pads used per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 pad used at baseline
Number of Pads Used per Week   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Pads/week
Number Analyzed 201 participants 193 participants 771 participants 1165 participants
17.3  (26.1) 19.2  (22.0) 17.7  (17.6) 17.9  (20.0)
[1]
Measure Description: The number of pads used per week was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to the first dose of double-blind treatment.
[2]
Measure Analysis Population Description: FAS population with ≥ 1 pad used at baseline
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Hide Description A TEAE was defined as an adverse event (AE) observed after taking the first dose of double-blind treatment until 14 days after taking the last dose of double-blind treatment for non-serious AEs and until 30 days after taking the last dose of double-blind treatment for serious adverse events (SAEs). This included abnormal laboratory tests, vital signs or electrocardiogram data that were defined as AEs if the abnormality induced clinical signs or symptoms, required active intervention, interruption or discontinuation of study drug or was clinically significant in the investigator's opinion. The severity of each AE was defined according to the following: Mild (No disruption of normal daily activities); Moderate (Affected normal daily activities) and Severe (Inability to perform daily activities).
Time Frame From first dose of double-blind study drug up to 30 days after last dose of double-blind study drug (up to 56 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population was the safety analysis set (SAF), which consisted of all participants who received ≥ 1 dose of double-blind study drug and excluded participants from one site due to protocol noncompliance.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 305 303 1206
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAEs
126
  41.3%
134
  44.2%
596
  49.4%
Mild TEAEs
61
  20.0%
69
  22.8%
306
  25.4%
Moderate TEAEs
52
  17.0%
58
  19.1%
238
  19.7%
Severe TEAEs
13
   4.3%
7
   2.3%
52
   4.3%
Drug-related TEAEs
35
  11.5%
42
  13.9%
200
  16.6%
Serious TEAEs
8
   2.6%
8
   2.6%
51
   4.2%
Drug-related Serious TEAEs
1
   0.3%
0
   0.0%
0
   0.0%
TEAEs Leading to Discontuation of Study Drug
7
   2.3%
5
   1.7%
25
   2.1%
Drug-related TEAEs Leading to Discont. of Drug
4
   1.3%
4
   1.3%
17
   1.4%
TEAEs Leading to Death
0
   0.0%
0
   0.0%
1
   0.1%
2.Primary Outcome
Title Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours
Hide Description An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and week 52 clinic visits.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; Last observation carried forward (LOCF) was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 301 297 1184
Least Squares Mean (Standard Error)
Unit of Measure: incontinence episodes
-1.58  (0.11) -1.90  (0.11) -2.03  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.69 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.37 to 0.11
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline to EoT in Mean Number of Micturitions Per 24 Hours
Hide Description A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and week 52 clinic visits.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 301 297 1184
Least Squares Mean (Standard Error)
Unit of Measure: micturitions
-2.10  (0.13) -2.16  (0.13) -2.58  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-0.77 to -0.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments The 2-sided P value was for pairwise comparisons between the combination therapy group and the corresponding monotherapy group from the ANCOVA model.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.71 to -0.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.15
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to EoT in Mean Volume Voided Per Micturition
Hide Description The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 289 293 1162
Least Squares Mean (Standard Error)
Unit of Measure: mL
21.83  (3.12) 24.90  (3.10) 37.67  (1.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 15.84
Confidence Interval (2-Sided) 95%
8.99 to 22.69
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.49
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 12.77
Confidence Interval (2-Sided) 95%
5.98 to 19.57
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.47
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline to EoT in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 290 294 1163
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-21.96  (1.14) -24.91  (1.13) -29.51  (0.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -7.55
Confidence Interval (2-Sided) 95%
-10.05 to -5.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -4.60
Confidence Interval (2-Sided) 95%
-7.09 to -2.12
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.27
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline to EoT in the Patient's Assessment of Treatment Satisfaction-Visual Analogue Scale (TS-VAS)
Hide Description The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame Baseline and Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with baseline and at least one post-baseline measurement; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 289 294 1163
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
2.19  (0.12) 2.15  (0.12) 2.73  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.55
Confidence Interval (2-Sided) 95%
0.28 to 0.82
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg: Difference of the adjusted mean (i.e., least squares mean) was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.59
Confidence Interval (2-Sided) 95%
0.32 to 0.86
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Incontinence Episodes Per 24 Hours
Hide Description An incontinence episode was defined as the complaint of any involuntary leakage of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in a micturition diary for 7 days prior to the baseline and prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: incontinence episodes
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
-0.97  (0.10) -1.29  (0.11) -1.45  (0.05)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
-1.31  (0.11) -1.71  (0.11) -1.78  (0.05)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
-1.42  (0.11) -1.78  (0.11) -1.93  (0.05)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
-1.53  (0.11) -1.90  (0.11) -2.00  (0.06)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
-1.67  (0.11) -1.92  (0.11) -2.06  (0.06)
8.Secondary Outcome
Title Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Mean (Standard Error)
Unit of Measure: incontinence episodes
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
14.88  (1.52) 12.41  (1.22) 10.80  (0.58)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
12.23  (1.12) 9.23  (1.02) 8.33  (0.52)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
10.62  (1.08) 8.18  (1.01) 7.28  (0.48)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
10.53  (1.19) 7.28  (0.91) 6.74  (0.45)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
9.09  (1.10) 7.06  (0.94) 6.10  (0.46)
EoT Number Analyzed 301 participants 297 participants 1184 participants
10.32  (1.08) 8.09  (0.94) 6.85  (0.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Effects Poisson-Negative Binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.54 to 0.84
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of incontinence episodes divided by number of valid diary days) at baseline included as a covariate and number of valid diary day at EoT as the offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method Mixed Effects Poisson-Negative Binomial
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.77
Confidence Interval (2-Sided) 95%
0.61 to 0.97
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.12
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description An incontinence episode was defined as the complaint of any involuntary leakage of urine. The number of incontinence episodes was the total number of times a participant records an incontinence episode during the 7-day micturition diary period prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: incontinence episodes
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
-6.77  (0.73) -9.17  (0.73) -10.31  (0.36)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
-9.21  (0.76) -12.05  (0.75) -12.55  (0.38)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
-10.36  (0.76) -12.50  (0.75) -13.49  (0.37)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
-10.62  (0.76) -13.51  (0.77) -14.06  (0.38)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
-11.84  (0.77) -13.47  (0.77) -14.43  (0.38)
EoT Number Analyzed 301 participants 297 participants 1184 participants
-11.17  (0.75) -13.37  (0.75) -14.29  (0.37)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -3.12
Confidence Interval (2-Sided) 95%
-4.76 to -1.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.83
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-2.57 to 0.72
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.84
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Number of Incontinence-Free Days During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description The number of incontinence-free days was the number of valid diary days during the 7-day micturition diary period prior to each visit with no incontinence episodes recorded.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with with data available at each time point; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Mean (Standard Error)
Unit of Measure: incontinence-free days
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
2.73  (0.15) 3.35  (0.17) 3.46  (0.08)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
3.30  (0.17) 3.98  (0.17) 4.17  (0.08)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
3.64  (0.17) 4.08  (0.17) 4.44  (0.08)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
3.97  (0.18) 4.33  (0.17) 4.56  (0.08)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
4.23  (0.18) 4.5  (0.18) 4.81  (0.08)
EoT Number Analyzed 301 participants 297 participants 1184 participants
3.98  (0.17) 4.29  (0.16) 4.64  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.60
Confidence Interval (2-Sided) 95%
1.26 to 2.01
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.38
Confidence Interval (2-Sided) 95%
1.08 to 1.75
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Incontinence-Free Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description The number of incontinence-free days with < 8 micturitions per day was the number of valid diary days during the 7-day micturition diary period with no incontinence episodes recorded and with < 8 micturitions per day.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Mean (Standard Error)
Unit of Measure: days
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
1.03  (0.10) 1.01  (0.10) 1.33  (0.06)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
1.24  (0.12) 1.48  (0.13) 1.91  (0.07)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
1.56  (0.14) 1.66  (0.14) 2.13  (0.08)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
1.56  (0.14) 1.64  (0.14) 2.20  (0.08)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
1.87  (0.15) 1.92  (0.15) 2.54  (0.08)
EoT Number Analyzed 301 participants 297 participants 1184 participants
1.75  (0.14) 1.90  (0.14) 2.43  (0.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.61
Confidence Interval (2-Sided) 95%
1.26 to 2.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and log transformed baseline mean number of incontinence episodes per 24 hours and baseline mean number of micturitions per 24 hours as a covariates.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
1.14 to 1.85
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Incontinence Episodes Per 24 Hours
Hide Description An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes was calculated from data recorded by the participant in a micturition diary for 7 days prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 297 1187
Least Squares Mean (Standard Error)
Unit of Measure: urgency incontinence episodes
Month 1 Number Analyzed 291 participants 286 participants 1152 participants
-0.93  (0.10) -1.25  (0.10) -1.43  (0.05)
Month 3 Number Analyzed 282 participants 286 participants 1132 participants
-1.30  (0.10) -1.64  (0.10) -1.71  (0.05)
Month 6 Number Analyzed 266 participants 271 participants 1101 participants
-1.40  (0.10) -1.67  (0.10) -1.86  (0.05)
Month 9 Number Analyzed 264 participants 259 participants 1066 participants
-1.60  (0.11) -1.78  (0.11) -1.92  (0.05)
Month 12 Number Analyzed 258 participants 254 participants 1043 participants
-1.60  (0.10) -1.82  (0.10) -1.98  (0.05)
EoT Number Analyzed 301 participants 295 participants 1178 participants
-1.51  (0.10) -1.81  (0.10) -1.94  (0.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.43
Confidence Interval (2-Sided) 95%
-0.65 to -0.21
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.13
Confidence Interval (2-Sided) 95%
-0.36 to 0.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.11
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceeded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 297 1187
Mean (Standard Error)
Unit of Measure: urgency incontinence episodes
Month 1 Number Analyzed 291 participants 286 participants 1152 participants
13.14  (1.42) 11.21  (1.19) 8.99  (0.47)
Month 3 Number Analyzed 282 participants 286 participants 1132 participants
10.37  (1.00) 8.12  (0.98) 6.95  (0.44)
Month 6 Number Analyzed 266 participants 271 participants 1101 participants
8.97  (0.95) 7.31  (0.96) 5.88  (0.41)
Month 9 Number Analyzed 264 participants 259 participants 1066 participants
8.08  (1.01) 6.51  (0.89) 5.47  (0.40)
Month 12 Number Analyzed 258 participants 254 participants 1043 participants
7.73  (1.00) 6.06  (0.85) 4.88  (0.38)
EoT Number Analyzed 301 participants 295 participants 1178 participants
8.86  (0.98) 7.04  (0.86) 5.57  (0.40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days at EoT as the offset variable
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.48 to 0.79
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of incontinence episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of urgency incontinence episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day at EoT as the offset variable
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.75
Confidence Interval (2-Sided) 95%
0.58 to 0.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Urgency Incontinence Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description An urgency incontinence episode was defined as the involuntary leakage of urine accompanied by or immediately preceded by urgency. The number of urgency incontinence episodes was the total number of urgency incontinence episodes recorded by the participant during the 7-day micturition diary period prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 urgency incontinence episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: urgency incontinence episodes
Month 1 Number Analyzed 291 participants 286 participants 1152 participants
-6.45  (0.69) -8.77  (0.69) -10.1  (0.34)
Month 3 Number Analyzed 282 participants 286 participants 1132 participants
-9.06  (0.72) -11.48  (0.71) -11.99  (0.36)
Month 6 Number Analyzed 266 participants 271 participants 1101 participants
-10.09  (0.72) -11.71  (0.71) -13.0  (0.35)
Month 9 Number Analyzed 264 participants 259 participants 1066 participants
-11.1  (0.72) -12.6  (0.73) -13.44  (0.36)
Month 12 Number Analyzed 258 participants 254 participants 1043 participants
-11.27  (0.71) -12.8  (0.71) -13.8  (0.35)
EoT Number Analyzed 301 participants 295 participants 1178 participants
-10.61  (0.7) 12.66  (0.7) -13.59  (0.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the mirabegron monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.98
Confidence Interval (2-Sided) 95%
-4.51 to -1.46
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments The two-sided p-value is for pairwise comparisons between the combination therapy group and the solifenacin monotherapy group from stratified rank ANCOVA.
Method Stratified Rank ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Stratified Rank ANCOVA
Estimated Value -0.93
Confidence Interval (2-Sided) 95%
-2.47 to 0.61
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.78
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9 and 12 in Mean Number of Micturitions Per 24 Hours
Hide Description A micturition was defined as any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours was calculated from data recorded by the participant in a micturition diary for 7-days before the baseline and prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: micturitions
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
-1.09  (0.12) -1.36  (0.12) -1.64  (0.06)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
-1.63  (0.13) -1.87  (0.12) 2.16  (0.06)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
-1.85  (0.13) -2.04  (0.13) -2.39  (0.06)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
-2.03  (0.13) -2.03  (0.13) -2.42  (0.06)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
-2.20  (0.13) -2.13  (0.14) -2.64  (0.07)
16.Secondary Outcome
Title Number of Days With < 8 Micturitions Per Day During the 7-Day Micturition Diary Period Prior to Each Visit (at Months 1, 3, 6, 9, 12 and EoT)
Hide Description The number of days with < 8 micturitions was the number of valid diary days during the 7-day micturition diary period with with less than 8 micturitions per day.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Mean (Standard Error)
Unit of Measure: days
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
1.90  (0.13) 1.60  (0.12) 2.08  (0.07)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
2.07  (0.14) 2.14  (0.14) 2.66  (0.08)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
2.35  (0.15) 2.34  (0.15) 2.87  (0.08)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
2.38  (0.16) 2.33  (0.15) 2.93  (0.08)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
2.61  (0.16) 2.58  (0.16) 3.17  (0.08)
EoT Number Analyzed 301 participants 297 participants 1184 participants
2.52  (0.15) 2.58  (0.15) 3.10  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Mirabegron 50 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.44
Confidence Interval (2-Sided) 95%
1.14 to 1.8
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Odds ratio vs. Solifenacin 5 mg (EoT): Odds ratio was from a overdispersed binomial regression model including treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as factors and baseline mean number of micturitions per 24 hours as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments [Not Specified]
Method Overdispersed Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.09 to 1.73
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Change From Baseline to EoT in Corrected Micturition Frequency
Hide Description Corrected micturition frequency was defined as the mean number of micturitions per 24 hours that participants had at end of treatment if their fluid intake had remained unchanged since baseline. Corrected micturition frequency was calculated as the baseline mean volume voided per micturition multiplied by the baseline mean number of micturitions per 24 hours divided by the mean volume voided per micturition at EoT.
Time Frame Baseline and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population; LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 301 297 1184
Least Squares Mean (Standard Error)
Unit of Measure: micturitions
-0.72  (0.17) -1.11  (0.17) -1.51  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.78
Confidence Interval (2-Sided) 95%
-1.16 to -0.41
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline mean number of micturitions per 24 hours as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.40
Confidence Interval (2-Sided) 95%
-0.77 to -0.02
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Change From Baseline to Months 3, 6 and 12 in Mean Volume Voided Per Micturition
Hide Description The mean volume voided per micturition was calculated from the data recorded by the participant during 3 consecutive days with volume measurements during the 7-day micturition diary period prior to each visit.
Time Frame Baseline and Months 3, 6, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: mL
Month 3 Number Analyzed 274 participants 280 participants 1125 participants
15.34  (2.96) 23.71  (2.92) 34.89  (1.45)
Month 6 Number Analyzed 265 participants 268 participants 1102 participants
20.87  (3.21) 27.08  (3.19) 38.56  (1.57)
Month 12 Number Analyzed 248 participants 254 participants 1028 participants
21.85  (3.42) 24.05  (3.37) 38.72  (1.67)
19.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours
Hide Description Urgency was defined as a complaint of a sudden, compelling desire to pass urine, which is difficult to defer. An urgency episode was defined as any micturition or incontinence episode recorded by the participant in the micturition diary for 7 days prior to each visit as 3 or 4 on the Patient Perception of Intensity of Urgency Scale (PPIUS), where 0 = No urgency; 1 = Mild urgency; 2 = Moderate urgency, could delay voiding a short while; 3 = Severe urgency, could not delay voiding; 4 = Urge incontinence, leaked before arriving to the toilet.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Participants with ≥ 1 urgency episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: urgency episodes
Month 1 Number Analyzed 291 participants 288 participants 1158 participants
-1.93  (0.17) -2.31  (0.17) -2.68  (0.09)
Month 3 Number Analyzed 282 participants 288 participants 1137 participants
-2.68  (0.17) -3.02  (0.17) -3.36  (0.08)
Month 6 Number Analyzed 266 participants 273 participants 1107 participants
-2.93  (0.17) -3.17  (0.17) -3.72  (0.08)
Month 9 Number Analyzed 264 participants 261 participants 1070 participants
-3.40  (0.18) -3.55  (0.18) -3.87  (0.09)
Month 12 Number Analyzed 258 participants 256 participants 1048 participants
-3.40  (0.17) -3.56  (0.17) -3.95  (0.09)
EoT Number Analyzed 301 participants 297 participants 1184 participants
-3.11  (0.17) -3.45  (0.17) -3.84  (0.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.73
Confidence Interval (2-Sided) 95%
-1.10 to -0.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.39
Confidence Interval (2-Sided) 95%
-0.76 to -0.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Nocturia Episodes Per 24 Hours
Hide Description A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The mean number of nocturia episodes was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit."
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 262 252 1027
Least Squares Mean (Standard Error)
Unit of Measure: nocturia episodes
Month 1 Number Analyzed 253 participants 244 participants 1000 participants
-0.20  (0.04) -0.22  (0.04) -0.34  (0.02)
Month 3 Number Analyzed 247 participants 244 participants 985 participants
-0.34  (0.04) -0.38  (0.04) -0.46  (0.02)
Month 6 Number Analyzed 231 participants 231 participants 958 participants
-0.41  (0.05) -0.39  (0.05) -0.49  (0.02)
Month 9 Number Analyzed 229 participants 221 participants 927 participants
-0.42  (0.05) -0.44  (0.05) -0.50  (0.02)
Month 12 Number Analyzed 225 participants 217 participants 906 participants
-0.46  (0.05) -0.44  (0.05) -0.56  (0.02)
EoT Number Analyzed 262 participants 251 participants 1023 participants
-0.45  (0.04) -0.45  (0.04) -0.55  (0.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.059
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.19 to 0.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.068
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.09
Confidence Interval (2-Sided) 95%
-0.19 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.05
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Number of Nocturia Episodes Reported During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 262 252 1027
Mean (Standard Error)
Unit of Measure: nocturia episodes
Month 1 Number Analyzed 253 participants 244 participants 1000 participants
8.76  (0.41) 9.23  (0.44) 8.00  (0.20)
Month 3 Number Analyzed 247 participants 244 participants 985 participants
7.93  (0.39) 7.92  (0.40) 7.17  (0.19)
Month 6 Number Analyzed 231 participants 231 participants 958 participants
7.12  (0.35) 7.86  (0.43) 6.96  (0.20)
Month 9 Number Analyzed 229 participants 221 participants 927 participants
7.40  (0.38) 7.48  (0.41) 6.84  (0.20)
Month 12 Number Analyzed 225 participants 217 participants 906 participants
6.88  (0.38) 7.39  (0.44) 6.33  (0.19)
EoT Number Analyzed 262 participants 251 participants 1023 participants
7.13  (0.37) 7.47  (0.42) 6.51  (0.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.067
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.90
Confidence Interval (2-Sided) 95%
0.81 to 1.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio of number of nocturia episodes during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group was calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of nocturia episodes divided by number of valid diary days) included as a covariate and post baseline number of valid diary day as the offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.92
Confidence Interval 95%
0.82 to 1.03
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.06
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Nocturia Episodes During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description A nocturia episode was defined as waking at night 1 or more times to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the participant gets up in the morning with the intention to stay awake). The number of nocturia episodes was the number of times a participant recorded a nocturia episode during the 7-day micturition diary period prior to each visit
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 nocturia episode at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 262 252 1027
Least Squares Mean (Standard Error)
Unit of Measure: nocturia episodes
Month 1 Number Analyzed 253 participants 244 participants 1000 participants
-1.56  (0.29) -1.58  (0.29) -2.39  (0.15)
Month 3 Number Analyzed 247 participants 244 participants 985 participants
-2.45  (0.29) -2.78  (0.30) -3.26  (0.15)
Month 6 Number Analyzed 231 participants 231 participants 958 participants
-3.08  (0.33) -2.81  (0.33) -3.44  (0.16)
Month 9 Number Analyzed 229 participants 221 participants 927 participants
-2.91  (0.32) -3.13  (0.32) -3.55  (0.16)
Month 12 Number Analyzed 225 participants 217 participants 906 participants
-3.29  (0.32) -3.08  (0.33) -3.97  (0.16)
EoT Number Analyzed 262 participants 251 participants 1023 participants
-3.24  (0.31) -3.20  (0.32) -3.90  (0.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.67
Confidence Interval (2-Sided) 95%
-1.34 to 0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.35
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean was calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.70
Confidence Interval (2-Sided) 95%
-1.39 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.35
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Mean Number of Pads Used Per 24 Hours
Hide Description The mean number of pads used per 24 hours was calculated from data recorded by the participant in the micturition diary for 7 days prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 pads used at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 201 193 771
Least Squares Mean (Standard Error)
Unit of Measure: pads
Month 1 Number Analyzed 193 participants 185 participants 741 participants
-0.67  (0.10) -0.96  (0.11) -1.25  (0.05)
Month 3 Number Analyzed 188 participants 184 participants 734 participants
-1.12  (0.11) -1.30  (0.11) -1.49  (0.06)
Month 6 Number Analyzed 174 participants 173 participants 712 participants
-1.30  (0.12) -1.24  (0.12) -1.59  (0.06)
Month 9 Number Analyzed 173 participants 166 participants 689 participants
-1.38  (0.12) -1.31  (0.13) -1.65  (0.06)
Month 12 Number Analyzed 170 participants 162 participants 678 participants
-1.35  (0.12) -1.37  (0.13) -1.67  (0.06)
EoT Number Analyzed 200 participants 191 participants 762 participants
-1.23  (0.12) -1.38  (0.12) -1.66  (0.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.69 to -0.16
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.13
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.28
Confidence Interval (2-Sided) 95%
-0.55 to -0.01
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Time Frame Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 201 193 771
Mean (Standard Error)
Unit of Measure: pads
Month 1 Number Analyzed 193 participants 185 participants 741 participants
12.67  (1.98) 12.55  (1.59) 8.75  (0.50)
Month 3 Number Analyzed 188 participants 184 participants 734 participants
9.61  (1.12) 9.47  (1.28) 7.23  (0.5)
Month 6 Number Analyzed 174 participants 173 participants 712 participants
7.99  (1.03) 9.16  (1.28) 6.51  (0.47)
Month 9 Number Analyzed 173 participants 166 participants 689 participants
7.65  (1.08) 8.91  (1.28) 6.18  (0.46)
Month 12 Number Analyzed 170 participants 162 participants 678 participants
7.60  (1.05) 8.09  (1.23) 5.70  (0.44)
EoT Number Analyzed 200 participants 191 participants 762 participants
9.09  (1.07) 8.54  (1.10) 6.33  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio vs. Mirabegron 50 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the mirabegron monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.58
Confidence Interval (2-Sided) 95%
0.45 to 0.76
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Rate ratio vs. Solifenacin 5 mg (EoT): Rate ratio of number of pads during the EoT 7-day diary between the combination therapy group and the solifenacin monotherapy group is calculated from a negative binomial regression model incl. treatment group, sex, age group (< 65, ≥ 65 years), geographic region and previous study history as factors, log(number of pads divided by number of valid diary days) included as a covariate and post baseline number of valid diary days as the offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments [Not Specified]
Method Negative Binomial Regression
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio
Estimated Value 0.76
Confidence Interval (2-Sided) 95%
0.58 to 0.99
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.14
Estimation Comments [Not Specified]
25.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Number of Pads Used During the 7-Day Micturition Diary Period Prior to Each Visit
Hide Description The number of pads used was the number of times a participant recorded a new pad used during the 7-day micturition diary period prior to each visit.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. Only participants with ≥ 1 pad used at baseline were included in the analysis. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 201 193 771
Least Squares Mean (Standard Error)
Unit of Measure: pads
Month 1 Number Analyzed 193 participants 185 participants 741 participants
-4.74  (0.71) -6.72  (0.72) -8.89  (0.36)
Month 3 Number Analyzed 188 participants 184 participants 734 participants
-7.83  (0.77) -9.21  (0.78) 10.47  (0.39)
Month 6 Number Analyzed 174 participants 173 participants 712 participants
-9.09  (0.85) -8.86  (0.85) -11.12  (0.42)
Month 9 Number Analyzed 173 participants 166 participants 689 participants
-9.59  (0.87) -9.33  (0.89) -11.44  (0.43)
Month 12 Number Analyzed 170 participants 162 participants 678 participants
-9.39  (0.85) -9.92  (0.87) -11.66  (0.42)
EoT Number Analyzed 200 participants 191 participants 762 participants
-8.59  (0.82) -9.89  (0.84) -11.58  (0.42)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -2.98
Confidence Interval (2-Sided) 95%
-4.78 to -1.18
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.92
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.072
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -1.68
Confidence Interval (2-Sided) 95%
-3.52 to 0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.93
Estimation Comments [Not Specified]
26.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9 and 12 in the OAB-q Symptom Bother Score
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, rated on a 6-point Likert scale (1 through 6). The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
-16.37  (1.08) -20.82  (1.07) -22.86  (0.54)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
-19.69  (1.08) -23.13  (1.07) -26.88  (0.53)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
-20.97  (1.14) -24.27  (1.12) -27.73  (0.55)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
-21.41  (1.15) -25.82  (1.14) -28.45  (0.56)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
-23.41  (1.19) -25.38  (1.18) -30.18  (0.58)
27.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in Health-Related Quality of Life Questionnaire (HRQoL): Total Score
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. The total score was calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
11.67  (0.92) 14.01  (0.91) 15.69  (0.45)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
15.25  (0.95) 16.41  (0.94) 19.26  (0.47)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
16.63  (1.02) 17.96  (1.00) 20.03  (0.49)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
16.69  (1.02) 18.53  (1.01) 20.75  (0.50)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
17.33  (1.04) 18.80  (1.03) 21.82  (0.51)
EoT Number Analyzed 290 participants 294 participants 1163 participants
16.57  (1.00) 18.47  (0.99) 21.33  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 4.76
Confidence Interval (2-Sided) 95%
2.56 to 6.96
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.86
Confidence Interval (2-Sided) 95%
0.68 to 5.04
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.11
Estimation Comments [Not Specified]
28.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Coping
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
13.05  (1.09) 15.40  (1.08) 17.58  (0.54)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
17.57  (1.14) 18.38  (1.13) 21.64  (0.56)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
19.68  (1.22) 20.53  (1.19) 22.73  (0.59)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
19.54  (1.21) 21.21  (1.20) 23.58  (0.59)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
19.47  (1.25) 21.90  (1.23) 24.86  (0.61)
EoT Number Analyzed 290 participants 294 participants 1163 participants
18.54  (1.19) 21.13  (1.18) 24.14  (0.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.60
Confidence Interval (2-Sided) 95%
2.99 to 8.20
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.33
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 3.01
Confidence Interval (2-Sided) 95%
0.43 to 5.60
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.32
Estimation Comments [Not Specified]
29.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Concern
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
13.24  (1.03) 15.49  (1.02) 17.60  (0.51)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
16.37  (1.05) 17.64  (1.04) 21.23  (0.52)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
17.77  (1.10) 19.05  (1.07) 21.73  (0.53)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
18.15  (1.11) 19.74  (1.10) 22.30  (0.54)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
19.10  (1.12) 19.40  (1.10) 23.30  (0.54)
EoT Number Analyzed 290 participants 294 participants 1163 participants
17.98  (1.08) 19.22  (1.07) 23.00  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.01
Confidence Interval (2-Sided) 95%
2.65 to 7.38
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 3.78
Confidence Interval (2-Sided) 95%
1.43 to 6.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.20
Estimation Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQoL Subscale Score: Sleep
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consisted of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each time was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
10.96  (1.08) 14.24  (1.07) 15.82  (0.54)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
14.09  (1.12) 16.71  (1.10) 19.75  (0.55)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
14.84  (1.22) 17.70  (1.19) 20.09  (0.59)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
14.86  (1.22) 17.73  (1.21) 21.15  (0.60)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
16.53  (1.29) 18.28  (1.27) 22.17  (0.63)
EoT Number Analyzed 290 participants 294 participants 1163 participants
16.44  (1.22) 18.32  (1.21) 21.59  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.15
Confidence Interval (2-Sided) 95%
2.47 to 7.83
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.36
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 3.27
Confidence Interval (2-Sided) 95%
0.62 to 5.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.35
Estimation Comments [Not Specified]
31.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9, 12 and EoT in HRQL Subscale Score: Social
Hide Description The OAB-q is a self-reported questionnaire with items relating to symptom bother and HRQoL. The HRQoL portion consists of 25 HRQoL items comprising 4 HRQoL subscales (Coping, Concern, Sleep, and Social Interaction), each item was scored 1-6. HRQoL subscales (coping, concern, sleep and social) and total score were transformed to range from 0 (worst quality of life) to 100 (best quality of life), with higher scores indicating better quality of life. A positive change from baseline indicated an improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point. LOCF was used for EoT.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 281 participants 286 participants 1132 participants
7.99  (0.84) 9.41  (0.83) 9.89  (0.42)
Month 3 Number Analyzed 278 participants 286 participants 1137 participants
11.14  (0.85) 11.19  (0.84) 12.22  (0.42)
Month 6 Number Analyzed 260 participants 272 participants 1108 participants
11.89  (0.89) 12.54  (0.87) 13.30  (0.43)
Month 9 Number Analyzed 261 participants 264 participants 1077 participants
11.92  (0.90) 13.33  (0.89) 13.64  (0.44)
Month 12 Number Analyzed 250 participants 255 participants 1049 participants
12.25  (0.90) 13.47  (0.89) 14.52  (0.44)
EoT Number Analyzed 290 participants 294 participants 1163 participants
11.57  (0.87) 13.22  (0.87) 14.25  (0.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Mirabegron 50 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Mirabegron 50 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the mirabegron monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.68
Confidence Interval (2-Sided) 95%
0.77 to 4.59
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.98
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Solifenacin 5 mg, Solifenacin 5 mg + Mirabegron 50 mg
Comments Difference vs. Solifenacin 5 mg (EoT): Difference of the adjusted mean is calculated by subtracting the adjusted mean of the solifenacin monotherapy group from the adjusted mean of the combination therapy group (solifenacin 5 mg + mirabegron 50 mg) based on the ANCOVA model with treatment group, sex, age group (< 65, ≥ 65 years), previous study history and geographic region as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.287
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
-0.87 to 2.93
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.97
Estimation Comments [Not Specified]
32.Secondary Outcome
Title Change From Baseline to Months 1, 3, 6, 9 and 12 in the Patient's Assessment of TS-VAS
Hide Description The TS-VAS is a visual analogue scale which asks participants to rate their satisfaction with the treatment by placing a vertical mark on a line that runs from 0 (No, not at all) on the left to 10 (Yes, completely) on the right. A positive change from baseline indicated improvement.
Time Frame Baseline and Months 1, 3, 6, 9, 12
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population with data available at each time point.
Arm/Group Title Mirabegron 50 mg Solifenacin 5 mg Solifenacin 5 mg + Mirabegron 50 mg
Hide Arm/Group Description:
Participants received mirabegron 50 mg once a day for 52 weeks.
Participants received solifenacin 5 mg once a day for 52 weeks.
Participants received solifenacin 5 mg and mirabegron 50 mg once a day for 52 weeks.
Overall Number of Participants Analyzed 302 299 1193
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Month 1 Number Analyzed 280 participants 286 participants 1131 participants
1.88  (0.12) 1.95  (0.12) 2.27  (0.06)
Month 3 Number Analyzed 277 participants 286 participants 1136 participants