Trial Outcomes & Findings for A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin) (NCT NCT01908829)

Results Overview

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary \& at least 1 micturition postbaseline \& reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2174 participants

Primary outcome timeframe

Baseline and end of treatment (up to 12 weeks)

Results posted on

2024-10-31

Participant Flow

This multicenter study was conducted at 281 centers globally. Randomization was stratified by sex, age group (\< 65, ≥ 65 years), 4-week incontinence episode reduction group (\< 50%, ≥ 50%) and geographic region.

Participants who met the screening inclusion/exclusion criteria went through a two week wash-out period and maintained a micturition diary during that the wash-out period. A total of 3815 participants were screened of which 2401 participants received solifenacin 5 mg run-in medication. A total of 2174 participants were randomized.

Participant milestones

Participant milestones
Measure	Combination (Solifenacin + Mirabegron) Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Overall Study STARTED	727	728	719
Overall Study Treated With Double-blind Drug	725	728	719
Overall Study COMPLETED	678	679	680
Overall Study NOT COMPLETED	49	49	39

Reasons for withdrawal

Reasons for withdrawal
Measure	Combination (Solifenacin + Mirabegron) Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Overall Study Adverse Event	13	11	13
Overall Study Lost to Follow-up	4	2	1
Overall Study Randomized no double-blind drug received	1	0	1
Overall Study Discontinued (no EoT page)	2	0	0
Overall Study Miscellaneous	0	2	0
Overall Study Protocol Violation	2	2	0
Overall Study Lack of Efficacy	1	3	2
Overall Study Withdrawal by Subject	26	29	22

Baseline Characteristics

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combination (Solifenacin + Mirabegron) n=727 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=728 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=719 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.	Total n=2174 Participants Total of all reporting groups
Age, Continuous	58.2 Year STANDARD_DEVIATION 13.1 • n=99 Participants	56.9 Year STANDARD_DEVIATION 13.5 • n=107 Participants	57.4 Year STANDARD_DEVIATION 13.2 • n=206 Participants	57.5 Year STANDARD_DEVIATION 13.3 • n=7 Participants
Sex: Female, Male Female	604 Participants n=99 Participants	604 Participants n=107 Participants	600 Participants n=206 Participants	1808 Participants n=7 Participants
Sex: Female, Male Male	123 Participants n=99 Participants	124 Participants n=107 Participants	119 Participants n=206 Participants	366 Participants n=7 Participants

PRIMARY outcome

Timeframe: Baseline and end of treatment (up to 12 weeks)

Population: The analysis population consisted of the FAS. LOCF was used for EoT.

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period. The analysis population consisted of the Full Analysis Set (FAS) which comprised of all the Randomized Analysis Set's (RAS) participants who met the following criteria: took at least 1 dose of double-blind study drug after randomization, reported at least 1 micturition in the baseline diary \& at least 1 micturition postbaseline \& reported at least 1 incontinence episode in the baseline diary. For participants who withdrew before EoT (week 12) and have no measurement available for that diary period, the Last Observation Carried Forward (LOCF) value during the double-blind study period was used as EoT value to derive the primary variable.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=706 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=704 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=697 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline to End of Treatment (EoT) in Mean Number of Incontinence Episodes Per 24 Hours	-1.8 incontinence episodes Standard Error 0.08	-1.53 incontinence episodes Standard Error 0.08	-1.67 incontinence episodes Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: The analysis population consisted of the FAS with data available at each time point.

The mean number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from number of incontinence episodes recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours Week 4	-1.24 incontinence episodes Standard Error 0.07	-0.91 incontinence episodes Standard Error 0.07	-1.12 incontinence episodes Standard Error 0.07
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours Week 8	-1.68 incontinence episodes Standard Error 0.07	-1.29 incontinence episodes Standard Error 0.07	-1.49 incontinence episodes Standard Error 0.07
Change From Baseline to Weeks 4, 8 & 12 in Mean Number of Incontinence Episodes Per 24 Hours Week 12	-1.81 incontinence episodes Standard Error 0.08	-1.57 incontinence episodes Standard Error 0.08	-1.67 incontinence episodes Standard Error 0.08

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The average number of micturitions (voluntary urinations (excluding incontinence only episodes)) per 24 hours was derived from number of micturitions recorded on valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period (excluding incontinence only episodes).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Number of Micturitions Per 24 Hours Week 4	-0.95 micturitions Standard Error 0.07	-0.69 micturitions Standard Error 0.07	-0.79 micturitions Standard Error 0.07
Change From Baseline in Mean Number of Micturitions Per 24 Hours Week 8	-1.36 micturitions Standard Error 0.08	-0.94 micturitions Standard Error 0.08	-1.00 micturitions Standard Error 0.08
Change From Baseline in Mean Number of Micturitions Per 24 Hours Week 12	-1.63 micturitions Standard Error 0.08	-1.16 micturitions Standard Error 0.09	-1.11 micturitions Standard Error 0.08
Change From Baseline in Mean Number of Micturitions Per 24 Hours EoT	-1.59 micturitions Standard Error 0.08	-1.14 micturitions Standard Error 0.08	-1.12 micturitions Standard Error 0.08

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The number of incontinence episodes (complaint of any involuntary leakage of urine) per day was derived from total number of incontinence episodes on valid diary days recorded during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Incontinence Episodes Reported During the 3-Day Diary Week 4	5.81 incontinence episodes Standard Error 0.30	6.68 incontinence episodes Standard Error 0.31	6.41 incontinence episodes Standard Error 0.33
Number of Incontinence Episodes Reported During the 3-Day Diary Week 8	4.55 incontinence episodes Standard Error 0.30	5.43 incontinence episodes Standard Error 0.30	5.28 incontinence episodes Standard Error 0.32
Number of Incontinence Episodes Reported During the 3-Day Diary Week 12	4.03 incontinence episodes Standard Error 0.29	4.56 incontinence episodes Standard Error 0.28	4.62 incontinence episodes Standard Error 0.31
Number of Incontinence Episodes Reported During the 3-Day Diary EoT	4.25 incontinence episodes Standard Error 0.29	4.87 incontinence episodes Standard Error 0.28	4.72 incontinence episodes Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

MVV per micturition was defined as MVV (mL) per micturition during last 3 days of the 3-day micturition diary period. MVV per micturition was calculated as the sum of each volume voided for each record with volume voided \> 0 on valid diary days divided by the total number of records with a volume voided \> 0 on valid diary days during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Volume Voided (MVV) Per Micturition Week 4	15.06 mL Standard Error 1.55	11.20 mL Standard Error 1.55	14.99 mL Standard Error 1.55
Change From Baseline in Mean Volume Voided (MVV) Per Micturition Week 8	25.21 mL Standard Error 1.89	14.02 mL Standard Error 1.87	21.08 mL Standard Error 1.86
Change From Baseline in Mean Volume Voided (MVV) Per Micturition Week 12	29.54 mL Standard Error 2.06	17.16 mL Standard Error 2.08	20.99 mL Standard Error 2.04
Change From Baseline in Mean Volume Voided (MVV) Per Micturition EoT	28.05 mL Standard Error 1.97	16.52 mL Standard Error 1.97	20.30 mL Standard Error 1.97

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used. The analysis population consisted of the FAS.

CMF was defined as the mean number of micturitions per 24 hours that participants would have at EoT if their fluid intake had remained unchanged since baseline. This was calculated by the MVV per Micturition at baseline multiplied by the mean number of micturitions per 24 hours at baseline divided by the MVV per micturition at EoT.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=706 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=704 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=697 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline to EoT in Corrected Micturition Frequency (CMF)	-0.96 micturitions Standard Error 0.10	-0.52 micturitions Standard Error 0.10	-0.71 micturitions Standard Error 0.10

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.

UI was defined as the complaint of involuntary urine leakage accompanied by or immediately preceded by urgency. UI was measured using the Patient Perception of Intensity of Urgency Scale (PPIUS), a patient reported outcome validated 5-point categorical scale rating the degree of associated urinary urgency severity (0=No urgency, I felt no need to empty my bladder, but did so for other reasons. 1=Mild, I could postpone voiding as long as necessary, without fear of wetting myself. 2= Moderate, I could postpone voiding for a short while, without fear of wetting myself. 3=Severe, I could not postpone voiding, but had to rush to the toilet in order not to wet myself. 4=Urgency incontinence, I leaked before arriving to the toilet). One urgency incontinence episode was counted for each record of the diary in which the following occurred: incontinence episode or 'both' was recorded \& severity of urinary urgency recorded was 3 or 4.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours Week 4	-1.26 UI episodes Standard Error 0.07	-0.91 UI episodes Standard Error 0.07	-1.14 UI episodes Standard Error 0.07
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours Week 8	-1.70 UI episodes Standard Error 0.07	-1.25 UI episodes Standard Error 0.07	-1.45 UI episodes Standard Error 0.07
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours Week 12	-1.84 UI episodes Standard Error 0.07	-1.58 UI episodes Standard Error 0.07	-1.62 UI episodes Standard Error 0.07
Change From Baseline in Mean Number of Urgency Incontinence (UI) Episodes Per 24 Hours EoT	-1.82 UI episodes Standard Error 0.07	-1.54 UI episodes Standard Error 0.07	-1.63 UI episodes Standard Error 0.07

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one UI episode reported in baseline diary were included.

Number of UI episodes was calculated using the number of UI episodes recorded on valid diary days during the 3-day micturition diary period. NOTE: Only urgency incontinence episodes recorded on a valid diary day were counted.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of UI Episodes Reported During the 3-Day Diary Week 4	4.96 UI episodes Standard Error 0.27	5.86 UI episodes Standard Error 0.29	5.50 UI episodes Standard Error 0.30
Number of UI Episodes Reported During the 3-Day Diary Week 8	3.55 UI episodes Standard Error 0.25	4.76 UI episodes Standard Error 0.27	4.50 UI episodes Standard Error 0.30
Number of UI Episodes Reported During the 3-Day Diary Week 12	3.10 UI episodes Standard Error 0.24	3.78 UI episodes Standard Error 0.25	3.91 UI episodes Standard Error 0.30
Number of UI Episodes Reported During the 3-Day Diary EoT	3.33 UI episodes Standard Error 0.24	4.00 UI episodes Standard Error 0.25	3.96 UI episodes Standard Error 0.29

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one urgency episode reported in baseline diary were included.

An urgency episode was defined as the complaint of a sudden, compelling desire to pass urine, which is difficult to defer. The mean number of urgency episodes (severity of 3 or 4) per 24 hours was defined as the average number of times a participant recorded an urgency episode (severity of 3 or 4) with or without incontinence per day during the 3-day micturition diary period. Measured using the PPIUS scale. This was calculated using the sum of each record with an urgency episode (severity of 3 or 4) recorded on a valid diary day divided by the number of valid diary days during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours Week 4	-1.84 urgency episodes Standard Error 0.09	-1.39 urgency episodes Standard Error 0.09	-1.74 urgency episodes Standard Error 0.10
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours Week 8	-2.64 urgency episodes Standard Error 0.10	-2.00 urgency episodes Standard Error 0.10	-2.29 urgency episodes Standard Error 0.10
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours Week 12	-2.97 urgency episodes Standard Error 0.11	-2.44 urgency episodes Standard Error 0.11	-2.55 urgency episodes Standard Error 0.11
Change From Baseline in Mean Number of Urgency Episodes (Grade 3 and/or 4) Per 24 Hours EoT	-2.95 urgency episodes Standard Error 0.10	-2.41 urgency episodes Standard Error 0.10	-2.54 urgency episodes Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with reported use of at least one pad reported in baseline diary were included.

The mean number of pads per 24 hours was defined as the average number of times a participant recorded a new pad used per day during the 3-day micturition diary period. This was calculated using the number of new pads used during valid diary days during the 3-day micturition diary period divided by the number of valid diary days during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Number of Pads Per 24 Hours Week 4	-1.12 pads Standard Error 0.07	-0.86 pads Standard Error 0.07	-1.04 pads Standard Error 0.07
Change From Baseline in Mean Number of Pads Per 24 Hours Week 8	-1.50 pads Standard Error 0.07	-1.17 pads Standard Error 0.08	-1.36 pads Standard Error 0.08
Change From Baseline in Mean Number of Pads Per 24 Hours Week 12	-1.65 pads Standard Error 0.07	-1.38 pads Standard Error 0.07	-1.43 pads Standard Error 0.07
Change From Baseline in Mean Number of Pads Per 24 Hours EoT	-1.66 pads Standard Error 0.07	-1.35 pads Standard Error 0.07	-1.43 pads Standard Error 0.07

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants who reported use of at least one pad in baseline diary were included.

The number of pads used was defined as the number of times a participant recorded a new pad used during the 3-day micturition diary period. This was calculated using the sum of each record with new pad checked. Only records with new pad checked on a valid diary day were counted.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Pads Used During the 3-Day Diary Week 4	4.80 pads Standard Error 0.28	5.69 pads Standard Error 0.36	5.41 pads Standard Error 0.29
Number of Pads Used During the 3-Day Diary Week 8	3.64 pads Standard Error 0.24	4.71 pads Standard Error 0.37	4.50 pads Standard Error 0.29
Number of Pads Used During the 3-Day Diary Week 12	3.23 pads Standard Error 0.22	4.13 pads Standard Error 0.28	4.07 pads Standard Error 0.28
Number of Pads Used During the 3-Day Diary EoT	3.29 pads Standard Error 0.22	4.27 pads Standard Error 0.28	4.17 pads Standard Error 0.29

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.

Mean number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) while sleeping during the 3-day diary period, divided by the number of valid diary days during the diary period. Night time episode of incontinence only was not considered a nocturia episode. Nocturia episodes were counted for each micturition record which occurred between the date/time of going to bed with intention to sleep and the date/time of getting up with intention to stay awake on a valid diary day \& which was accompanied by a sleep interruption. Nocturia only determined for those who were not night-shift workers.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Mean Number of Nocturia Episodes Week 4	-0.28 nocturia episodes Standard Error 0.03	-0.27 nocturia episodes Standard Error 0.03	-0.29 nocturia episodes Standard Error 0.03
Change From Baseline in Mean Number of Nocturia Episodes Week 8	-0.37 nocturia episodes Standard Error 0.03	-0.35 nocturia episodes Standard Error 0.03	-0.37 nocturia episodes Standard Error 0.03
Change From Baseline in Mean Number of Nocturia Episodes Week 12	-0.46 nocturia episodes Standard Error 0.03	-0.38 nocturia episodes Standard Error 0.03	-0.41 nocturia episodes Standard Error 0.03
Change From Baseline in Mean Number of Nocturia Episodes EoT	-0.43 nocturia episodes Standard Error 0.03	-0.37 nocturia episodes Standard Error 0.03	-0.41 nocturia episodes Standard Error 0.03

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point. Only participants with at least one nocturia episode reported in baseline diary were included.

The number of nocturia episodes was defined as the number of times a participant urinated (excluding incontinence only episodes) during sleeping time during the 3-day micturition diary period. This was calculated using the sum of each nocturia episode recorded on valid diary days during the 3-day micturition diary period.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Nocturia Episodes Reported Over 3-Day Diary Week 12	3.12 nocturia episodes Standard Error 0.13	3.26 nocturia episodes Standard Error 0.12	3.23 nocturia episodes Standard Error 0.12
Number of Nocturia Episodes Reported Over 3-Day Diary Week 4	3.63 nocturia episodes Standard Error 0.12	3.59 nocturia episodes Standard Error 0.12	3.58 nocturia episodes Standard Error 0.12
Number of Nocturia Episodes Reported Over 3-Day Diary Week 8	3.33 nocturia episodes Standard Error 0.12	3.35 nocturia episodes Standard Error 0.12	3.32 nocturia episodes Standard Error 0.12
Number of Nocturia Episodes Reported Over 3-Day Diary EoT	3.16 nocturia episodes Standard Error 0.12	3.28 nocturia episodes Standard Error 0.11	3.19 nocturia episodes Standard Error 0.12

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> no data	2 participants	4 participants	5 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> no data	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> severe problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> slight problems	33 participants	35 participants	36 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> no problems	409 participants	370 participants	374 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> moderate problems	14 participants	11 participants	11 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> severe problems	0 participants	7 participants	4 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No problems -> extreme problems	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> no problems	52 participants	58 participants	60 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> slight problems	43 participants	46 participants	40 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> moderate problems	15 participants	28 participants	16 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> severe problems	1 participants	3 participants	3 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Slight problems -> no data	2 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> no problems	24 participants	36 participants	25 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> slight problems	25 participants	18 participants	23 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> moderate problems	28 participants	28 participants	40 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> severe problems	2 participants	3 participants	7 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Moderate problems -> extreme problems	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> no problems	7 participants	8 participants	2 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> slight problems	6 participants	7 participants	7 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> moderate problems	17 participants	11 participants	11 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> severe problems	12 participants	10 participants	14 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Severe problems -> no data	1 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> no problems	3 participants	2 participants	2 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> slight problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> moderate problems	1 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility Extreme problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> no problems	4 participants	9 participants	13 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> slight problems	2 participants	4 participants	1 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> moderate problems	0 participants	3 participants	3 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> severe problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in Euroqol European Quality of Life-5 Dimensions (EQ-5D) Subscale Score: Mobility No data -> no data	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> no data	6 participants	5 participants	4 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> no problems	37 participants	25 participants	32 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> slight problems	23 participants	24 participants	22 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> moderate problems	9 participants	7 participants	9 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> severe problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> severe problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> slight problems	0 participants	2 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> no data	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> no problems	548 participants	541 participants	548 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> slight problems	28 participants	26 participants	25 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> moderate problems	0 participants	14 participants	7 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No problems -> severe problems	3 participants	0 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Slight problems -> no data	0 participants	0 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> no problems	12 participants	16 participants	7 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> slight problems	9 participants	9 participants	5 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> moderate problems	11 participants	7 participants	12 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> severe problems	0 participants	2 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Moderate problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> no problems	7 participants	5 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> slight problems	2 participants	2 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> moderate problems	2 participants	1 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> severe problems	1 participants	4 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Severe problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> no problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> slight problems	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care Extreme problems -> moderate problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> no problems	6 participants	14 participants	17 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> moderate problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> severe problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Self-care No data -> extreme problems	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> no problems	397 participants	384 participants	379 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> severe problems	1 participants	4 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> extreme problems	0 participants	0 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> no problems	75 participants	81 participants	78 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> severe problems	3 participants	3 participants	4 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> extreme problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> slight problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> moderate problems	3 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> moderate problems	0 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> slight problems	38 participants	30 participants	42 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> moderate problems	12 participants	19 participants	11 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No problems -> no data	4 participants	3 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> slight problems	46 participants	45 participants	37 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> moderate problems	12 participants	16 participants	15 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> severe problems	1 participants	1 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> extreme problems	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Slight problems -> no data	0 participants	1 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> no problems	29 participants	35 participants	25 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> slight problems	22 participants	20 participants	28 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> moderate problems	22 participants	18 participants	21 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Moderate problems -> no data	2 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> no problems	9 participants	8 participants	12 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> slight problems	7 participants	5 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> moderate problems	7 participants	6 participants	9 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> severe problems	5 participants	7 participants	9 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Severe problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> no problems	2 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> severe problems	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities Extreme problems -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> no problems	5 participants	11 participants	15 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> slight problems	1 participants	4 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> severe problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> extreme problems	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Usual Activities No data -> no data	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> extreme pain	0 participants	0 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> moderate pain	11 participants	16 participants	16 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> severe pain	10 participants	4 participants	9 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> extreme pain	0 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> severe pain	6 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> slight pain	1 participants	3 participants	4 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> no data	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> no pain	4 participants	8 participants	11 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> no pain	299 participants	290 participants	283 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> slight pain	45 participants	62 participants	51 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> moderate pain	12 participants	14 participants	17 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> severe pain	3 participants	9 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No pain -> no data	4 participants	4 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> no pain	79 participants	82 participants	81 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> slight pain	58 participants	64 participants	55 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> moderate pain	28 participants	17 participants	31 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> severe pain	0 participants	2 participants	5 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> extreme pain	1 participants	2 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Slight pain -> no data	0 participants	0 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> no pain	39 participants	36 participants	21 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> slight pain	37 participants	36 participants	39 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> moderate pain	34 participants	30 participants	39 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> severe pain	7 participants	4 participants	8 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> extreme pain	0 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Moderate pain -> no data	2 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> no pain	7 participants	4 participants	10 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Severe pain -> slight pain	12 participants	7 participants	4 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> no pain	4 participants	1 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> slight pain	0 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> moderate pain	1 participants	0 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> extreme pain	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort Extreme pain -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> moderate pain	1 participants	5 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> severe pain	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Pain/Discomfort No data -> extreme pain	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and EoT (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The EQ-5D is an international, standardized, nondisease specific instrument for describing and valuing health status. It has 5 dimensions: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has 5 response levels: level 1=no problem or none; level 2=slight problems; level 3=moderate problems; level 4=severe problems; level 5=unable to perform activity.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious -> not anxious	322 participants	300 participants	307 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious -> severely anxious	2 participants	2 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious -> no data	4 participants	3 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> extremely anxious	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> not anxious	36 participants	38 participants	34 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> slightly anxious	36 participants	40 participants	33 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious -> slightly anxious	43 participants	39 participants	43 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious -> moderately anxious	11 participants	17 participants	15 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Not anxious-> extremely anxious	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> not anxious	107 participants	99 participants	90 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> slightly anxious	56 participants	60 participants	69 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> moderately anxious	13 participants	11 participants	23 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> severely anxious	1 participants	2 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Slightly anxious -> no data	1 participants	2 participants	2 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> moderately anxious	22 participants	26 participants	17 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> severely anxious	3 participants	7 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> extremely anxious	0 participants	3 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Moderately anxious -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> not anxious	10 participants	8 participants	8 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> slightly anxious	9 participants	5 participants	5 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> moderately anxious	6 participants	6 participants	11 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> severely anxious	5 participants	8 participants	7 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> extremely anxious	0 participants	3 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Severely anxious -> no data	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> not anxious	1 participants	4 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> slightly anxious	2 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> moderately anxious	4 participants	2 participants	3 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> severely anxious	4 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> extremely anxious	1 participants	2 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression Extremely anxious -> no data	1 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> not anxious	5 participants	13 participants	11 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> slightly anxious	0 participants	2 participants	5 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> moderately anxious	1 participants	1 participants	1 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> severely anxious	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> extremely anxious	0 participants	0 participants	0 participants
Number of Participants With Change From Baseline to EoT in EQ-5D Subscale Score: Anxiety/Depression No data -> no data	1 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score Week 12	-27.90 units on a scale Standard Error 0.71	-22.31 units on a scale Standard Error 0.71	-24.09 units on a scale Standard Error 0.71
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score Week 4	-16.68 units on a scale Standard Error 0.65	-13.79 units on a scale Standard Error 0.65	-15.82 units on a scale Standard Error 0.65
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score Week 8	-22.86 units on a scale Standard Error 0.68	-18.36 units on a scale Standard Error 0.69	-19.34 units on a scale Standard Error 0.69
Change From Baseline in Overactive Bladder Symptom (OAB-q) Symptom Bother Score EoT	-26.89 units on a scale Standard Error 0.69	-21.93 units on a scale Standard Error 0.70	-23.59 units on a scale Standard Error 0.70

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score Week 8	17.58 units on a scale Standard Error 0.63	15.26 units on a scale Standard Error 0.63	14.60 units on a scale Standard Error 0.64
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score EoT	20.78 units on a scale Standard Error 0.65	17.63 units on a scale Standard Error 0.65	17.40 units on a scale Standard Error 0.65
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score Week 4	12.95 units on a scale Standard Error 0.59	11.03 units on a scale Standard Error 0.59	12.44 units on a scale Standard Error 0.59
Change From Baseline in OAB-q Health-Related Quality of Life (HRQL) Total Score Week 12	21.40 units on a scale Standard Error 0.66	17.91 units on a scale Standard Error 0.67	17.72 units on a scale Standard Error 0.66

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in OAB-q HRQL Subscale Score: Coping Week 12	25.16 units on a scale Standard Error 0.78	20.45 units on a scale Standard Error 0.78	20.20 units on a scale Standard Error 0.78
Change From Baseline in OAB-q HRQL Subscale Score: Coping EoT	24.48 units on a scale Standard Error 0.75	20.19 units on a scale Standard Error 0.76	19.90 units on a scale Standard Error 0.76
Change From Baseline in OAB-q HRQL Subscale Score: Coping Week 4	15.17 units on a scale Standard Error 0.68	12.27 units on a scale Standard Error 0.68	14.25 units on a scale Standard Error 0.68
Change From Baseline in OAB-q HRQL Subscale Score: Coping Week 8	20.82 units on a scale Standard Error 0.74	17.47 units on a scale Standard Error 0.74	16.87 units on a scale Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in OAB-q HRQL Subscale Score: Concern Week 4	13.79 units on a scale Standard Error 0.68	11.85 units on a scale Standard Error 0.68	13.82 units on a scale Standard Error 0.69
Change From Baseline in OAB-q HRQL Subscale Score: Concern Week 8	18.87 units on a scale Standard Error 0.70	16.36 units on a scale Standard Error 0.71	15.88 units on a scale Standard Error 0.71
Change From Baseline in OAB-q HRQL Subscale Score: Concern Week 12	22.85 units on a scale Standard Error 0.74	19.24 units on a scale Standard Error 0.75	19.67 units on a scale Standard Error 0.74
Change From Baseline in OAB-q HRQL Subscale Score: Concern Week EoT	22.28 units on a scale Standard Error 0.72	19.00 units on a scale Standard Error 0.73	19.28 units on a scale Standard Error 0.73

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in OAB-q HRQL Subscale Score: Sleep Week EoT	19.16 units on a scale Standard Error 0.72	17.30 units on a scale Standard Error 0.73	16.55 units on a scale Standard Error 0.73
Change From Baseline in OAB-q HRQL Subscale Score: Sleep Week 4	11.58 units on a scale Standard Error 0.68	11.04 units on a scale Standard Error 0.68	11.16 units on a scale Standard Error 0.69
Change From Baseline in OAB-q HRQL Subscale Score: Sleep Week 8	16.18 units on a scale Standard Error 0.71	14.57 units on a scale Standard Error 0.71	13.72 units on a scale Standard Error 0.71
Change From Baseline in OAB-q HRQL Subscale Score: Sleep Week 12	20.00 units on a scale Standard Error 0.74	17.74 units on a scale Standard Error 0.74	16.84 units on a scale Standard Error 0.74

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction Week 4	9.58 units on a scale Standard Error 0.59	7.85 units on a scale Standard Error 0.59	8.95 units on a scale Standard Error 0.59
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction Week 8	11.93 units on a scale Standard Error 0.60	10.84 units on a scale Standard Error 0.60	10.16 units on a scale Standard Error 0.60
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction Week 12	14.70 units on a scale Standard Error 0.61	12.08 units on a scale Standard Error 0.61	11.98 units on a scale Standard Error 0.61
Change From Baseline in OAB-q HRQL Subscale Score: Social Interaction EoT	14.39 units on a scale Standard Error 0.60	11.91 units on a scale Standard Error 0.60	11.72 units on a scale Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The TS-VAS rated participant satisfaction with treatment on a scale from 0 (No, not at all) to 10 (Yes, completely).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score Week 4	1.2 units on a scale Standard Error 0.1	0.8 units on a scale Standard Error 0.1	1.1 units on a scale Standard Error 0.1
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score Week 8	1.5 units on a scale Standard Error 0.1	1.2 units on a scale Standard Error 0.1	1.3 units on a scale Standard Error 0.1
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score Week 12	1.9 units on a scale Standard Error 0.1	1.4 units on a scale Standard Error 0.1	1.6 units on a scale Standard Error 0.1
Change From Baseline in Treatment Satisfaction - Visual Analogue Scale (TS-VAS) Score EoT	1.8 units on a scale Standard Error 0.1	1.4 units on a scale Standard Error 0.1	1.6 units on a scale Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition. PPBC score: 1-no problem, 2- some very minor problems, 3-some minor problems, 4-moderate problems, 5-severe problems, 6-many severe problems.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Patient Perception Bladder Control (PPBC) Score Week 4	-0.9 units on a scale Standard Error 0.0	-0.6 units on a scale Standard Error 0.0	-0.7 units on a scale Standard Error 0.0
Change From Baseline in Patient Perception Bladder Control (PPBC) Score Week 8	-1.2 units on a scale Standard Error 0.0	-1.0 units on a scale Standard Error 0.0	-1.0 units on a scale Standard Error 0.0
Change From Baseline in Patient Perception Bladder Control (PPBC) Score Week 12	-1.5 units on a scale Standard Error 0.0	-1.2 units on a scale Standard Error 0.0	-1.3 units on a scale Standard Error 0.0
Change From Baseline in Patient Perception Bladder Control (PPBC) Score EoT	-1.5 units on a scale Standard Error 0.0	-1.2 units on a scale Standard Error 0.0	-1.3 units on a scale Standard Error 0.0

SECONDARY outcome

Timeframe: End of treatment (up to 12 weeks)

Population: LOCF was used for EoT. The analysis population consisted of the FAS.

The PGIC was a 2-part questionnaire, assessing both the change in the participant's overall condition (Patient Impression in General Health (PIBS)) and change in bladder condition since the start of the study (Patient Impression in General Health (PIGH)) (from very much worse to very much improved). The CGIC was a single questionnaire assessing the participant's change in bladder condition since the beginning of the study (Clinician Impression in Bladder Symptoms (CIBS)).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Very Much Improved	227 participants	152 participants	171 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Minimally Worse	7 participants	11 participants	4 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Very Much Worse	1 participants	1 participants	2 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Much Worse	4 participants	3 participants	5 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Very Much Worse	3 participants	3 participants	4 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Much Improved	257 participants	264 participants	284 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Minimally Improved	135 participants	170 participants	152 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS No Change	25 participants	55 participants	56 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Much Worse	4 participants	4 participants	6 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIBS Very Much Worse	0 participants	1 participants	1 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Very Much Improved	144 participants	104 participants	108 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Much Improved	239 participants	236 participants	244 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Minimally Improved	143 participants	147 participants	146 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH No Change	113 participants	142 participants	160 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Minimally Worse	14 participants	23 participants	10 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) PIGH Much Worse	1 participants	4 participants	4 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Very Much Improved	184 participants	118 participants	141 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Much Improved	311 participants	316 participants	329 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Minimally Improved	141 participants	164 participants	155 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS No Change	23 participants	56 participants	40 participants
Number of Participants in Each Category of Patient and Clinician Global Impression of Change Scales (PGIC and CGIC) CIBS Minimally Worse	4 participants	8 participants	5 participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

Incontinence was defined as any involuntary leakage of urine.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Week 4	52.5 percentage of participants	43.3 percentage of participants	49.0 percentage of participants
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Week 8	66.9 percentage of participants	57.6 percentage of participants	61.8 percentage of participants
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours Week 12	72.4 percentage of participants	64.0 percentage of participants	66.9 percentage of participants
Percentage of Participants With at Least a 50% Decrease From Baseline in Mean Number of Incontinence Episodes Per 24 Hours EoT	71.2 percentage of participants	63.1 percentage of participants	66.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

Incontinence was defined as any involuntary leakage of urine.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With Zero Incontinence Episodes Postbaseline Week 4	23.5 percentage of participants	20.0 percentage of participants	22.1 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Postbaseline Week 8	40.4 percentage of participants	31.6 percentage of participants	34.3 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Postbaseline Week 12	47.3 percentage of participants	39.5 percentage of participants	40.7 percentage of participants
Percentage of Participants With Zero Incontinence Episodes Postbaseline EoT	46.0 percentage of participants	37.9 percentage of participants	40.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

Micturitions were defined as voluntary urinations (excluding incontinence only episodes).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline Week 4	21.0 percentage of participants	18.7 percentage of participants	20.2 percentage of participants
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline Week 8	28.1 percentage of participants	22.4 percentage of participants	26.3 percentage of participants
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline Week 12	31.4 percentage of participants	24.8 percentage of participants	28.0 percentage of participants
Percentage of Participants With a Mean of at Least 8 Micturitions Per 24 Hours at Baseline and Less Than 8 Micturitions Per 24 Hours Postbaseline EoT	30.2 percentage of participants	25.0 percentage of participants	27.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The OAB-q was a self-reported questionnaire comprising 33-items each rated on a 6-point Likert scale. The questionnaire consisted of an 8-item symptom bother scale and 25 health-related QoL (HRQL) items comprising 4 HRQL subscales (Coping, Concern, Sleep, and Social Interaction). Symptom Bother score ranges from 0 (least severity) to 100 (worst severity).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score Week 4	67.9 percentage of participants	58.2 percentage of participants	61.9 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score Week 8	77.2 percentage of participants	66.4 percentage of participants	69.1 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score Week 12	83.5 percentage of participants	72.1 percentage of participants	75.4 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in OAB-q Symptom Bother Score EoT	81.7 percentage of participants	71.7 percentage of participants	74.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

HRQL subscales (coping, concern, sleep and social) and total score range from 0 (worst quality of life) to 100 (best quality of life).

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score Week 4	52.6 percentage of participants	44.5 percentage of participants	48.1 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score Week 8	63.6 percentage of participants	54.8 percentage of participants	53.8 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score Week 12	70.5 percentage of participants	60.8 percentage of participants	60.4 percentage of participants
Percentage of Participants With at Least a 10-Point Improvement From Baseline in HRQL Total Score EoT	68.6 percentage of participants	60.6 percentage of participants	60.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC EoT	76.5 percentage of participants	69.5 percentage of participants	71.9 percentage of participants
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC Week 4	61.1 percentage of participants	52.1 percentage of participants	56.3 percentage of participants
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC Week 8	70.1 percentage of participants	62.1 percentage of participants	64.6 percentage of participants
Percentage of Participants With at Least a 1-Point Improvement From Baseline in PPBC Week 12	77.9 percentage of participants	70.4 percentage of participants	72.7 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: LOCF was used for EoT. The analysis population consisted of the FAS with data available at each time point.

The PPBC was a validated, global assessment tool using a 6-point Likert scale on which participants rated their subjective impression of their current bladder condition.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=707 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=705 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=698 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC Week 4	26.6 percentage of participants	21.6 percentage of participants	21.6 percentage of participants
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC Week 8	39.5 percentage of participants	31.5 percentage of participants	31.8 percentage of participants
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC Week 12	51.8 percentage of participants	39.8 percentage of participants	43.8 percentage of participants
Percentage of Participants With Major (at Least 2-Point) Improvement From Baseline in PPBC EoT	49.8 percentage of participants	39.1 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: From first dose of double blind treatment until 30 days after last dose (up to 16 weeks)

Population: The analysis population consisted of the Safety Analysis Set, the SAF comprised all randomized participants who received at least 1 dose of double-blind treatment.

AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures \& which does not necessarily have a causal relationship with this treatment. Treatment-Emergent Adverse Event (TEAE) referred to an adverse event which started or worsened in the period from first double-blind medication intake until 30 days after the last double-blind medication intake.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=725 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=728 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=719 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Number of Participants With Adverse Events (AEs) AEs	260 Participants	241 Participants	283 Participants
Number of Participants With Adverse Events (AEs) Drug-related AEs	141 Participants	125 Participants	161 Participants
Number of Participants With Adverse Events (AEs) Serious Adverse Events (SAEs)	13 Participants	10 Participants	15 Participants
Number of Participants With Adverse Events (AEs) Drug-related SAEs	1 Participants	0 Participants	3 Participants
Number of Participants With Adverse Events (AEs) AEs Leading to Perm. Disc. of Study Drug	11 Participants	11 Participants	11 Participants
Number of Participants With Adverse Events (AEs) Drug-related AEs Leading to Perm. Disc. of Drug	9 Participants	10 Participants	9 Participants
Number of Participants With Adverse Events (AEs) Deaths	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline and weeks 4, 8 & 12

Population: The analysis population consisted of the SAF with data available at each time point.

PVR Volume was assessed by bladder scan.

Outcome measures

Outcome measures
Measure	Combination (Solifenacin + Mirabegron) n=725 Participants Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=728 Participants Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=719 Participants Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Change From Baseline in Post Void Residual (PVR) Volume Week 4	1.545 mL Standard Deviation 40.313	2.821 mL Standard Deviation 38.588	7.308 mL Standard Deviation 72.122
Change From Baseline in Post Void Residual (PVR) Volume Week 8	2.245 mL Standard Deviation 38.347	1.117 mL Standard Deviation 36.470	7.232 mL Standard Deviation 60.096
Change From Baseline in Post Void Residual (PVR) Volume Week 12	6.356 mL Standard Deviation 51.067	2.337 mL Standard Deviation 42.147	6.552 mL Standard Deviation 48.505
Change From Baseline in Post Void Residual (PVR) Volume EoT	5.478 mL Standard Deviation 51.595	3.046 mL Standard Deviation 43.499	7.354 mL Standard Deviation 54.121

Adverse Events

Combination (Solifenacin + Mirabegron)

Serious events: 13 serious events

Other events: 43 other events

Deaths: 0 deaths

Solifenacin 5 mg

Serious events: 10 serious events

Other events: 41 other events

Deaths: 0 deaths

Solifenacin 10 mg

Serious events: 15 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Combination (Solifenacin + Mirabegron) n=725 participants at risk Participants received solifenacin 5 mg, mirabegron 25 mg and solifenacin 10 mg matching placebo once daily for the first 4 weeks of double-blind period. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron tablet was replaced by a 50 mg mirabegron tablet. Placebo was given for the 2 week single-blind safety follow-up period.	Solifenacin 5 mg n=728 participants at risk Participants received solifenacin 5 mg, mirabegron 25 mg matching placebo and solifenacin 10 mg matching placebo once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period	Solifenacin 10 mg n=719 participants at risk Participants received solifenacin 5 mg matching placebo, mirabegron 25 mg matching placebo and solifenacin 10 mg once daily. For the last 8 weeks of the double-blind treatment period, the 25 mg mirabegron matching placebo tablet was replaced by a 50 mg mirabegron matching placebo tablet (to maintain the blind). Placebo was given for the 2 week single-blind safety follow-up period.
Gastrointestinal disorders Dry mouth	5.9% 43/725 • Number of events 44 • From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) Population consisted of the SAF. An AE was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment.	5.6% 41/728 • Number of events 44 • From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) Population consisted of the SAF. An AE was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment.	9.5% 68/719 • Number of events 70 • From first dose of double blind treatment until 30 days after last dose (up to 16 weeks) Population consisted of the SAF. An AE was defined as any untoward medical occurrence in a participant administered a study drug or who had undergone study procedures and did not necessarily have a causal relationship with this treatment.

Additional Information

Clinical Trial Disclosure

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Publication restrictions are in place

Restriction type: OTHER