Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment. (NCT NCT01638000)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1887 participants

Primary outcome timeframe

Baseline and final visit (up to Week 12)

Results posted on

2024-11-21

Participant Flow

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

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

Participant milestones

Participant milestones
Measure	Mirabegron 50 mg Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Study STARTED	943	944
Overall Study Received at Least 1 Double-Blind Dose	936	934
Overall Study COMPLETED	883	873
Overall Study NOT COMPLETED	60	71

Reasons for withdrawal

Reasons for withdrawal
Measure	Mirabegron 50 mg Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg Participants who received solifenacin 5 mg once daily for 12 weeks.
Overall Study Randomized but Never Received Drug	7	10
Overall Study Adverse Event	14	16
Overall Study Lack of Efficacy	5	6
Overall Study Protocol Violation	11	13
Overall Study Withdrawal by Subject	21	24
Overall Study Miscellaneous	2	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mirabegron 50 mg n=936 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=934 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.	Total n=1870 Participants Total of all reporting groups
Age, Continuous	56.7 years STANDARD_DEVIATION 14.25 • n=5 Participants	57.4 years STANDARD_DEVIATION 13.60 • n=7 Participants	57.0 years STANDARD_DEVIATION 13.93 • n=5 Participants
Sex: Female, Male Female	712 Participants n=5 Participants	709 Participants n=7 Participants	1421 Participants n=5 Participants
Sex: Female, Male Male	224 Participants n=5 Participants	225 Participants n=7 Participants	449 Participants n=5 Participants
Mean Micturitions / 24 hours	11.6 micturitions STANDARD_DEVIATION 3.25 • n=5 Participants	11.4 micturitions STANDARD_DEVIATION 2.89 • n=7 Participants	11.5 micturitions STANDARD_DEVIATION 3.08 • n=5 Participants
Mean Incontinence Episodes / 24 hours	2.1 incontinence episodes STANDARD_DEVIATION 2.30 • n=5 Participants	2.1 incontinence episodes STANDARD_DEVIATION 2.05 • n=7 Participants	2.1 incontinence episodes STANDARD_DEVIATION 2.17 • n=5 Participants
Mean Urgency Incontinence Episodes / 24 hours	1.9 urgency incontinence episodes STANDARD_DEVIATION 1.99 • n=5 Participants	2.0 urgency incontinence episodes STANDARD_DEVIATION 1.94 • n=7 Participants	2.0 urgency incontinence episodes STANDARD_DEVIATION 1.96 • n=5 Participants
Mean Urgency Episodes (grade 3 or 4) / 24 hours	7.7 urgency episodes STANDARD_DEVIATION 4.75 • n=5 Participants	7.8 urgency episodes STANDARD_DEVIATION 4.46 • n=7 Participants	7.8 urgency episodes STANDARD_DEVIATION 4.61 • n=5 Participants
Mean Level of Urgency	2.6 units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants	2.6 units on a scale STANDARD_DEVIATION 0.49 • n=7 Participants	2.6 units on a scale STANDARD_DEVIATION 0.49 • n=5 Participants
Mean Nocturia Episodes / 24 hours	2.3 nocturia episodes STANDARD_DEVIATION 1.41 • n=5 Participants	2.3 nocturia episodes STANDARD_DEVIATION 1.42 • n=7 Participants	2.3 nocturia episodes STANDARD_DEVIATION 1.41 • n=5 Participants
Mean Number of Pads Used / 24 hours	3.1 pads STANDARD_DEVIATION 3.43 • n=5 Participants	3.3 pads STANDARD_DEVIATION 3.70 • n=7 Participants	3.2 pads STANDARD_DEVIATION 3.57 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=853 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours	-2.95 micturitions Standard Error 0.087	-3.13 micturitions Standard Error 0.088

SECONDARY outcome

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

Population: SAF population

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=936 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=934 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period Overall	5 percentage of participants	7.4 percentage of participants
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period Dry mouth	3.1 percentage of participants	5.8 percentage of participants
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period Dry throat	0.1 percentage of participants	0.1 percentage of participants
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period Blurred vision	0.6 percentage of participants	0.4 percentage of participants
Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period Constipation	2.2 percentage of participants	2.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours Week 4 [N=916,906]	-2.37 micturitions Standard Error 0.083	-2.33 micturitions Standard Error 0.083
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours Week 8 [N=888,876]	-2.77 micturitions Standard Error 0.084	-3.00 micturitions Standard Error 0.085
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours Week 12 [N=870,856]	-3.02 micturitions Standard Error 0.088	-3.21 micturitions Standard Error 0.089

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 8 [N=387,397]	2.19 incontinence episodes Standard Error 0.457	1.28 incontinence episodes Standard Error 0.135
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 12 [N=381,387]	2.07 incontinence episodes Standard Error 0.562	1.08 incontinence episodes Standard Error 0.124
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Final visit [N=404,413]	2.13 incontinence episodes Standard Error 0.533	1.29 incontinence episodes Standard Error 0.157
Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 4 [N=404,410]	2.64 incontinence episodes Standard Error 0.280	2.25 incontinence episodes Standard Error 0.217

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours Week 4 [N=404,410]	-1.22 incontinence episodes Standard Error 0.063	-1.30 incontinence episodes Standard Error 0.063
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours Week 8 [N=387,397]	-1.37 incontinence episodes Standard Error 0.093	-1.59 incontinence episodes Standard Error 0.092
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours Week 12 [N=381,387]	-1.41 incontinence episodes Standard Error 0.115	-1.66 incontinence episodes Standard Error 0.114

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 4 [N=395,399]	2.27 urgency incontinence episodes Standard Error 0.230	2.16 urgency incontinence episodes Standard Error 0.213
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 8 [N=379,386]	1.74 urgency incontinence episodes Standard Error 0.227	1.13 urgency incontinence episodes Standard Error 0.125
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 12 [N=373,377]	1.44 urgency incontinence episodes Standard Error 0.217	1.03 urgency incontinence episodes Standard Error 0.120
Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Final visit [N=395,402]	1.51 urgency incontinence episodes Standard Error 0.211	1.23 urgency incontinence episodes Standard Error 0.150

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 8 [N=379,386]	-1.39 urgency incontinence episodes Standard Error 0.050	-1.56 urgency incontinence episodes Standard Error 0.050
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 12 [N=373,377]	-1.49 urgency incontinence episodes Standard Error 0.047	-1.59 urgency incontinence episodes Standard Error 0.047
Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours Week 4 [N=395,399]	-1.22 urgency incontinence episodes Standard Error 0.057	-1.24 urgency incontinence episodes Standard Error 0.057

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Week 4 [N=915,905]	-3.75 urgency episodes Standard Error 0.113	-3.88 urgency episodes Standard Error 0.114
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Week 8 [N=887,875]	-4.44 urgency episodes Standard Error 0.111	-4.79 urgency episodes Standard Error 0.112
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Week 12 [N=869,855]	-4.67 urgency episodes Standard Error 0.116	-4.99 urgency episodes Standard Error 0.117
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours Final Visit [N=919,909]	-4.61 urgency episodes Standard Error 0.115	-4.84 urgency episodes Standard Error 0.115

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency Week 4 [N=916,906]	-0.36 units on a scale Standard Error 0.016	-0.36 units on a scale Standard Error 0.017
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency Week 8 [N=888,876]	-0.50 units on a scale Standard Error 0.019	-0.52 units on a scale Standard Error 0.019
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency Week 12 [N=870,856]	-0.60 units on a scale Standard Error 0.023	-0.60 units on a scale Standard Error 0.023
Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency Final visit [N=920,910]	-0.58 units on a scale Standard Error 0.022	-0.57 units on a scale Standard Error 0.022

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 4 [N=574,563]	4.25 pads Standard Error 0.324	4.26 pads Standard Error 0.297
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 8 [N=551,543]	3.33 pads Standard Error 0.284	3.27 pads Standard Error 0.236
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 12 [N=543,532]	3.19 pads Standard Error 0.304	3.04 pads Standard Error 0.244
Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit Final visit [N=576,565]	3.32 pads Standard Error 0.300	3.19 pads Standard Error 0.248

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8 , Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 8 [N=551,543]	-2.10 pads Standard Error 0.070	-2.14 pads Standard Error 0.070
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 4 [M=574,563]	-1.80 pads Standard Error 0.081	-1.82 pads Standard Error 0.081
Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 12 [N=543,532]	-2.14 pads Standard Error 0.078	-2.20 pads Standard Error 0.079

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 12 [N=831,828]	3.94 nocturia episodes Standard Error 0.115	4.06 nocturia episodes Standard Error 0.116
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Final Visit [N=879,875]	4.05 nocturia episodes Standard Error 0.120	4.13 nocturia episodes Standard Error 0.114
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 4 [N=877,871]	4.78 nocturia episodes Standard Error 0.120	5.12 nocturia episodes Standard Error 0.139
Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit Week 8 [N=850, 844]	4.26 nocturia episodes Standard Error 0.118	4.41 nocturia episodes Standard Error 0.117

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 4 [N=877,871]	-0.72 nocturia episodes Standard Error 0.033	-0.63 nocturia episodes Standard Error 0.034
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 8 [N=850,844]	-0.90 nocturia episodes Standard Error 0.031	-0.87 nocturia episodes Standard Error 0.031
Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment Week 12 [N=831,828]	-0.98 nocturia episodes Standard Error 0.032	-0.97 nocturia episodes Standard Error 0.033

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit Final visit [N=920,910]	44.2 percentage of participants	48.8 percentage of participants
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit Week 4 [N=916,906]	32.3 percentage of participants	33.9 percentage of participants
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit Week 8 [N=888,876]	41.2 percentage of participants	46.9 percentage of participants
Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit Week 12 [N=870,856]	44.8 percentage of participants	49.3 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 12 [N=381,387]	86.1 percentage of participants	89.1 percentage of participants
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 4 [N=404,410]	75.5 percentage of participants	77.3 percentage of participants
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 8 [N=387,397]	85.5 percentage of participants	86.9 percentage of participants
Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Final visit [N=404,413]	85.1 percentage of participants	88.1 percentage of participants

SECONDARY outcome

Timeframe: Week 4, Week 8, Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=405 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=413 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 4 [N=404,410]	47.3 percentage of participants	52.0 percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 8 [N=387,397]	64.3 percentage of participants	63.2 percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Final visit [N=404,413]	67.3 percentage of participants	68.5 percentage of participants
Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit Week 12 [N=381,387]	69.0 percentage of participants	69.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 4

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=905 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=896 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> Extreme problems	0 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> moderate problems	24 participants	11 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> severe problems	6 participants	3 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> slight problems	39 participants	45 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> no data	0 participants	2 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> no problems	2 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> slight problems	1 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> No problems	447 participants	443 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> Slight problems	45 participants	43 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> Moderate problems	23 participants	19 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> Severe problems	2 participants	6 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No problems -> no data	4 participants	3 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> no problems	66 participants	80 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> slight problems	47 participants	47 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Slight problems -> no data	1 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> no problems	39 participants	51 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> moderate problems	50 participants	46 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> severe problems	7 participants	6 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Moderate problems -> no data	0 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> no problems	20 participants	16 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> slight problems	24 participants	34 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> moderate problems	45 participants	29 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Severe problems -> severe problems	16 participants	12 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> no problems	1 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> slight problems	1 participants	1 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire No data -> no data	8 participants	7 participants

SECONDARY outcome

Timeframe: Baseline and Week 4

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=905 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=896 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	17 participants	15 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> No problems	693 participants	703 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	26 participants	23 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	12 participants	4 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	5 participants	5 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> No problems	37 participants	41 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	28 participants	16 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	8 participants	5 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	1 participants	2 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	24 participants	17 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	18 participants	28 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	1 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	9 participants	15 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	13 participants	15 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	7 participants	6 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	4 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	4 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	1 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	1 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	2 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	1 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	1 participants	2 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	1 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	8 participants	7 participants

SECONDARY outcome

Timeframe: Baseline and Week 4

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=905 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=896 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	21 participants	19 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	11 participants	13 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	7 participants	7 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	421 participants	422 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	61 participants	63 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	20 participants	10 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	4 participants	3 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	4 participants	4 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	102 participants	101 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	49 participants	58 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	14 participants	16 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	1 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	1 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	47 participants	34 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	59 participants	59 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	45 participants	39 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	9 participants	7 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	17 participants	28 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	3 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	0 participants	4 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	3 participants	5 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	5 participants	3 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	3 participants	1 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	0 participants	2 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	8 participants	7 participants

SECONDARY outcome

Timeframe: Baseline and Week 4

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=905 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=896 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	299 participants	285 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	57 participants	67 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	11 participants	17 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	1 participants	5 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	2 participants	4 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	101 participants	97 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	116 participants	109 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	32 participants	25 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	4 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	1 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	51 participants	44 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	60 participants	86 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	66 participants	65 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	12 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extrme problems	1 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	2 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	21 participants	19 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	22 participants	25 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	19 participants	17 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	20 participants	6 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	6 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	1 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	2 participants	6 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	3 participants	3 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	1 participants	2 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	2 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	1 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	0 participants	1 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	2 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	8 participants	7 participants

SECONDARY outcome

Timeframe: Baseline and Week 4

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=905 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=896 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	2 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	328 participants	339 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	59 participants	65 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	11 participants	11 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	2 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	2 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	4 participants	2 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	98 participants	102 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	122 participants	94 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	29 participants	25 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	5 participants	3 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	25 participants	33 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	64 participants	65 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	37 participants	40 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	12 participants	10 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	3 participants	1 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	12 participants	17 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	32 participants	29 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	26 participants	19 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	12 participants	9 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	2 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	1 participants	3 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	7 participants	12 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	8 participants	4 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	3 participants	5 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	4 participants	4 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	3 participants	5 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	1 participants	1 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	1 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	8 participants	7 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=882 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=875 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	445 participants	446 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	38 participants	31 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	20 participants	23 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	3 participants	3 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	14 participants	11 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	70 participants	78 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	46 participants	44 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	19 participants	12 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	3 participants	3 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	6 participants	6 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	51 participants	47 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	41 participants	52 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> modrate problems	31 participants	40 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	8 participants	6 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	4 participants	4 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	30 participants	22 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	30 participants	41 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	21 participants	15 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	20 participants	8 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	4 participants	7 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	1 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	1 participants	1 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	1 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	1 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	4 participants	4 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	3 participants	1 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	3 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=882 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=875 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	672 participants	673 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	35 participants	38 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	7 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	1 participants	1 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	20 participants	21 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	42 participants	33 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	19 participants	20 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	9 participants	9 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	1 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> exteme problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	3 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	34 participants	34 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	17 participants	16 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	5 participants	6 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	2 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	2 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	17 participants	13 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	9 participants	15 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	4 participants	8 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	2 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	1 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	1 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	4 participants	2 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	2 participants	1 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	6 participants	5 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	3 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=882 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=875 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	2 participants	5 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	26 participants	20 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	6 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	6 participants	6 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	13 participants	16 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	23 participants	32 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	12 participants	15 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	7 participants	3 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	5 participants	4 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	2 participants	5 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	2 participants	3 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	2 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	2 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	3 participants	4 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	5 participants	1 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	3 participants	4 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	430 participants	426 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	48 participants	49 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	15 participants	11 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	3 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	16 participants	13 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	101 participants	109 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	45 participants	50 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	16 participants	12 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	3 participants	2 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	3 participants	4 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	61 participants	53 participants
Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	57 participants	53 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=882 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=875 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	291 participants	286 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	52 participants	66 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	13 participants	16 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	4 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	10 participants	10 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	103 participants	96 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	111 participants	103 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	25 participants	30 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	6 participants	1 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	7 participants	5 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	59 participants	61 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	66 participants	78 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	46 participants	57 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	4 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	1 participants	1 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	8 participants	8 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	17 participants	16 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	37 participants	25 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	12 participants	15 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	18 participants	7 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	2 participants	1 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	2 participants	4 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	1 participants	3 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	4 participants	4 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	2 participants	4 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	1 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	1 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	4 participants	2 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	4 participants	3 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	3 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 8

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=882 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=875 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	325 participants	334 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	52 participants	65 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	15 participants	8 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	1 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	10 participants	13 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	122 participants	116 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	94 participants	79 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	26 participants	20 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	4 participants	3 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	3 participants	2 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	6 participants	4 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	42 participants	49 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	50 participants	59 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	31 participants	34 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	11 participants	4 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	7 participants	5 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	23 participants	13 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	39 participants	37 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	11 participants	12 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	7 participants	6 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	3 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	4 participants	6 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	9 participants	11 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	7 participants	10 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	2 participants	4 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	3 participants	1 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	3 participants	4 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	0 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	5 participants	2 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	3 participants	2 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	1 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	3 participants	4 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=857 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	15 participants	16 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	442 participants	459 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	36 participants	25 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	10 participants	10 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	6 participants	5 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	26 participants	16 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	77 participants	82 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	43 participants	32 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	2 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	7 participants	11 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	57 participants	63 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	31 participants	43 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	35 participants	30 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	7 participants	4 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	6 participants	9 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	53 participants	51 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	15 participants	17 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	15 participants	7 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	18 participants	8 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	5 participants	10 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	2 participants	1 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	0 participants	1 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	2 participants	9 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	5 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	3 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=857 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	667 participants	670 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	1 participants	3 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	26 participants	23 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	5 participants	6 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	1 participants	1 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	36 participants	36 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	43 participants	42 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	13 participants	12 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	14 participants	5 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	1 participants	1 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	3 participants	4 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	44 participants	46 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	8 participants	6 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	5 participants	6 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	1 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	2 participants	2 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	25 participants	25 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	4 participants	7 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	0 participants	2 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	3 participants	1 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	4 participants	4 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	3 participants	1 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	8 participants	9 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=857 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	425 participants	426 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	43 participants	45 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	14 participants	7 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	2 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	27 participants	22 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	103 participants	107 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	45 participants	53 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	12 participants	9 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	3 participants	1 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	6 participants	7 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	81 participants	79 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	41 participants	31 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	25 participants	15 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	6 participants	5 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	8 participants	9 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	31 participants	40 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	7 participants	13 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	6 participants	6 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	9 participants	5 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	3 participants	7 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	7 participants	7 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	1 participants	2 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	2 participants	3 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	1 participants	1 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	1 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	7 participants	8 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	3 participants	1 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=857 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	287 participants	299 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	50 participants	49 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	15 participants	11 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	4 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	17 participants	15 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	112 participants	116 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	97 participants	87 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	29 participants	18 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	4 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	12 participants	10 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	79 participants	80 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	49 participants	71 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	42 participants	38 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	6 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	10 participants	13 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	39 participants	34 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	14 participants	13 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	16 participants	12 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	12 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	2 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	5 participants	7 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	4 participants	5 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	2 participants	2 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	1 participants	3 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	1 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	1 participants	1 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	7 participants	5 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	4 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=865 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=857 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	323 participants	341 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	53 participants	48 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	10 participants	10 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	1 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	16 participants	20 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	132 participants	118 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	84 participants	80 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	26 participants	15 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	3 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	10 participants	9 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	52 participants	67 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	51 participants	44 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	18 participants	28 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	8 participants	5 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	2 participants	1 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	10 participants	6 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	38 participants	35 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	25 participants	17 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	7 participants	14 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	9 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	5 participants	9 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	10 participants	15 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	5 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	3 participants	7 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	2 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	4 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	9 participants	7 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	1 participants	2 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=906 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=897 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	460 participants	471 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	37 participants	25 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	14 participants	12 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	6 participants	5 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	3 participants	2 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	80 participants	88 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	45 participants	34 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	16 participants	18 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	2 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	1 participants	1 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	60 participants	67 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	33 participants	46 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	36 participants	31 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	7 participants	4 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	1 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	53 participants	52 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	15 participants	17 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	17 participants	11 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	20 participants	11 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	2 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	2 participants	1 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	1 participants	1 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	0 participants	1 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	2 participants	9 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	5 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	3 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=906 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=897 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	697 participants	699 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	27 participants	26 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	5 participants	6 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	1 participants	1 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	2 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	4 participants	4 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	43 participants	43 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	15 participants	14 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	15 participants	6 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	1 participants	1 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	45 participants	46 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	8 participants	6 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	6 participants	8 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	1 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	25 participants	25 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	4 participants	7 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	0 participants	4 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	4 participants	1 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	1 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	5 participants	4 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	1 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	1 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	8 participants	9 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme data	0 participants	0 participants
Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=906 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=897 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	444 participants	440 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	46 participants	49 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	15 participants	8 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	2 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	4 participants	3 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	106 participants	113 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	45 participants	54 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	15 participants	9 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	3 participants	1 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	83 participants	79 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	42 participants	34 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	29 participants	20 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	7 participants	6 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	31 participants	41 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	9 participants	14 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	6 participants	8 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	10 participants	5 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	3 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	7 participants	7 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problem	1 participants	2 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problem	2 participants	3 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problem	1 participants	1 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problem	1 participants	1 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	7 participants	8 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	3 participants	1 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=906 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=897 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	4 participants	5 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	2 participants	4 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	297 participants	306 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	55 participants	52 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	15 participants	13 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	4 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	2 participants	3 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	116 participants	118 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	103 participants	93 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	30 participants	20 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	2 participants	4 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	1 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	80 participants	83 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	51 participants	72 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	48 participants	44 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	7 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	0 participants	2 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	1 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	39 participants	34 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	16 participants	14 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	16 participants	15 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	15 participants	3 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	2 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	0 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	2 participants	2 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	1 participants	3 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	1 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	1 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	1 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	7 participants	5 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	1 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and final visit (up to Week 12)

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=906 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=897 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> moderate problems	11 participants	10 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> severe problems	2 participants	2 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no problems	133 participants	121 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> moderate problems	26 participants	17 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> extreme problems	0 participants	1 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> extreme problems	2 participants	1 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> extreme problems	3 participants	3 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> slight problems	52 participants	45 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no problems	332 participants	356 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> slight problems	55 participants	52 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> moderate problems	22 participants	29 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> severe problems	10 participants	6 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no data	0 participants	2 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no problems	38 participants	35 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> slight problems	25 participants	18 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No problems -> no data	3 participants	1 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> moderate problems	8 participants	15 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> severe problems	12 participants	6 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> extreme problems	1 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Severe problems -> no data	1 participants	3 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> slight problems	92 participants	83 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> no problems	10 participants	15 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> slight problems	6 participants	2 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> severe problems	4 participants	2 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> moderate problems	3 participants	7 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Extreme problems -> severe problems	3 participants	3 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Slight problems -> no data	0 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire Moderate problems -> no problems	55 participants	68 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no problems	9 participants	7 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> slight problems	1 participants	2 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> moderate problems	0 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> severe problems	0 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> extreme problems	0 participants	0 participants
Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire No data -> no data	1 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to symptom bother and health-related quality of life (HRQoL). The symptom bother portion consists of 8 items, scored from 1 to 6. The total symptom bother score was calculated from the 8 answers and then transformed to range from 0 (least severity) to 100 (worst severity). A negative change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) Week 4 [N=905,896]	-20.51 units on a scale Standard Error 0.576	-22.20 units on a scale Standard Error 0.579
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) Week 8 [N=882,875]	-25.96 units on a scale Standard Error 0.599	-27.76 units on a scale Standard Error 0.601
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) Week 12 [N=865,859]	-29.74 units on a scale Standard Error 0.647	-31.84 units on a scale Standard Error 0.649
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q) Final visit [N=906,897]	-28.89 units on a scale Standard Error 0.652	-30.76 units on a scale Standard Error 0.655

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

The OAB-q is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: coping, concern, sleep, social interaction). The total score is calculated by adding the 4 HRQoL subscale scores and transforming to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q Week 4 [N=905,896]	17.09 units on a scale Standard Error 0.543	18.23 units on a scale Standard Error 0.546
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q Week 8 [N=882,875]	21.66 units on a scale Standard Error 0.568	23.20 units on a scale Standard Error 0.570
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q Week 12 [N=865,859]	25.31 units on a scale Standard Error 0.611	26.85 units on a scale Standard Error 0.613
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q Final visit [N=906,897]	24.53 units on a scale Standard Error 0.616	25.94 units on a scale Standard Error 0.619

SECONDARY outcome

Timeframe: Baseline and Week 4, Week 8, Week 12

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

The Patient Perception of Bladder Condition (PPBC) questionnaire is a single-item questionnare used to assess participants' perceptions and impressions of their bladder condition. Participants assessed their bladder condition using a 6-point categorical scale: 1. Does not cause me any problems at all; 2. Causes me some very minor problems; 3. Causes me some minor problems; 4. Causes me (some) moderate problems; 5. Causes me severe problems; 6. Causes me many severe problems.

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) Week 4 [N=905,896]	-0.91 units on a scale Standard Error 0.035	-1.00 units on a scale Standard Error 0.035
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) Week 8 [N=882,875]	-1.30 units on a scale Standard Error 0.038	-1.46 units on a scale Standard Error 0.038
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) Week 12 [N=865,858]	-1.58 units on a scale Standard Error 0.042	-1.73 units on a scale Standard Error 0.042
Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC) Final visit [N=906,897]	-1.53 units on a scale Standard Error 0.042	-1.67 units on a scale Standard Error 0.042

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) Week 12 [N=865,857]	3.51 units on a scale Standard Error 0.099	3.93 units on a scale Standard Error 0.100
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS) Final visit [N=891,876]	3.44 units on a scale Standard Error 0.099	3.86 units on a scale Standard Error 0.100

SECONDARY outcome

Timeframe: Baseline and Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale Week 12 [N=876,871]	2.92 units on a scale Standard Error 0.050	3.07 units on a scale Standard Error 0.050
Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale Final visit [N=897,889]	2.88 units on a scale Standard Error 0.050	3.03 units on a scale Standard Error 0.050

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit Week 12 [N=865,859]	77.5 percentage of participants	82.4 percentage of participants
Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit Final visit [N=906,897]	76.2 percentage of participants	81.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit Week 12 [N=865,859]	69.2 percentage of participants	72.6 percentage of participants
Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit Final visit [N=906,897]	67.5 percentage of participants	71.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: FAS population.

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=876 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=871 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 ≥1 point improvement	86.4 percentage of participants	90.4 percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 ≥2 point improvement	80.3 percentage of participants	83.6 percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 ≥3 point improvement	67.7 percentage of participants	71.9 percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 ≥4 point improvement	44.4 percentage of participants	47.5 percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 ≥5 point improvement	15.6 percentage of participants	15.4 percentage of participants
Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12 6 point improvement	2.5 percentage of participants	2.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to final visit (up to Week 12)

Population: FAS population. LOCF was used.

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=897 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=889 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit ≥1 point improvement	85.6 percentage of participants	89.4 percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit ≥2 point improvement	79.0 percentage of participants	82.6 percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit ≥3 point improvement	66.7 percentage of participants	70.8 percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit ≥4 point improvement	43.8 percentage of participants	46.6 percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit ≥5 point improvement	15.4 percentage of participants	15.1 percentage of participants
Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit 6 point improvement	2.5 percentage of participants	2.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit Week 12 [N=865,858]	73.1 percentage of participants	76.7 percentage of participants
Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit Final visit [N=906,897]	71.9 percentage of participants	74.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline to Week 12

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

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

Outcome measures

Outcome measures
Measure	Mirabegron 50 mg n=921 Participants Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=912 Participants Participants who received solifenacin 5 mg once daily for 12 weeks.
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit Final visit [N=906,897]	46.2 percentage of participants	51.1 percentage of participants
Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit Week 12 [N=865,858]	47.6 percentage of participants	52.6 percentage of participants

Adverse Events

Mirabegron 50 mg

Serious events: 14 serious events

Other events: 29 other events

Deaths: 0 deaths

Solifenacin 5 mg

Serious events: 13 serious events

Other events: 54 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Mirabegron 50 mg n=936 participants at risk Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=934 participants at risk Participants who received solifenacin 5 mg once daily for 12 weeks.
Gastrointestinal disorders Dry mouth	3.1% 29/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	5.8% 54/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population

Additional Information

Medical Director

Astellas Pharma Europe Ltd

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript 45 days prior to publication for review and comment. Sponsor may delay the publication to seek patent protection.
Publication restrictions are in place

Restriction type: OTHER

Measure	Mirabegron 50 mg n=936 participants at risk Participants who received mirabegron 50 mg once daily for 12 weeks.	Solifenacin 5 mg n=934 participants at risk Participants who received solifenacin 5 mg once daily for 12 weeks.
Infections and infestations Pneumonia	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.21% 2/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Infections and infestations Appendicitis	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Infections and infestations Pyelonephritis	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Infections and infestations Pyelonephritis acute	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Infections and infestations Urosepsis	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Gastrointestinal disorders Abdominal pain upper	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Gastrointestinal disorders Inguinal hernia	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Gastrointestinal disorders Nausea	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Nervous system disorders Headache	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Nervous system disorders Lumbar radiculopathy	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Nervous system disorders Subarachnoid haemorrhage	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Ear and labyrinth disorders Vertigo	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Eye disorders Open angle glaucoma	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Eye disorders Vision blurred	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
General disorders Dysplasia	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
General disorders Pyrexia	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Hepatobiliary disorders Cholecystitis acute	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Hepatobiliary disorders Hepatitis acute	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Injury, poisoning and procedural complications Rib fracture	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Injury, poisoning and procedural complications Sternal fracture	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Injury, poisoning and procedural complications Traumatic lung injury	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Musculoskeletal and connective tissue disorders Neck pain	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Reproductive system and breast disorders Cervical dysplasia	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Reproductive system and breast disorders Vaginal haemorrhage	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Cardiac disorders Atrial fibrillation	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Investigations Liver function test abnormal	0.00% 0/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.11% 1/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Renal and urinary disorders Renal failure acute	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Skin and subcutaneous tissue disorders Rash	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Skin and subcutaneous tissue disorders Swelling face	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population
Vascular disorders Deep vein thrombosis	0.11% 1/936 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population	0.00% 0/934 • From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks) Safety Analysis Set population