Trial Outcomes & Findings for Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms (NCT NCT01018511)

NCT ID: NCT01018511

Last Updated: 2024-12-03

Results Overview

The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1334 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2024-12-03

Participant Flow

Prior to randomization, participants entered a single-blind placebo run-in period for 2 weeks and completed a 3-day micturition diary. After the placebo run-in period, participants' eligibility criteria were re-confirmed and the participants were then randomized into the double-blind treatment period of the study.

Participant milestones

Measure	Placebo Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Overall Study STARTED	341	327	339	327
Overall Study Randomized and Treated	341	326	338	324
Overall Study COMPLETED	315	295	299	294
Overall Study NOT COMPLETED	26	32	40	33

Reasons for withdrawal

Measure	Placebo Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Overall Study Not fulfilling eligibility criteria	6	7	7	3
Overall Study Adverse Event	5	9	13	10
Overall Study Lack of Efficacy	4	1	1	2
Overall Study Withdrawal by Subject	6	5	11	9
Overall Study Lost to Follow-up	0	0	1	0
Overall Study Protocol Violation	5	8	7	9
Overall Study Miscellaneous	0	2	0	0

Baseline Characteristics

Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms

Baseline characteristics by cohort

Measure	Placebo n=341 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=326 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=337 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=324 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	Total n=1328 Participants Total of all reporting groups
Age, Continuous	65.6 years STANDARD_DEVIATION 8.41 • n=5 Participants	65.1 years STANDARD_DEVIATION 7.98 • n=7 Participants	65.3 years STANDARD_DEVIATION 8.39 • n=5 Participants	65.5 years STANDARD_DEVIATION 7.71 • n=4 Participants	65.4 years STANDARD_DEVIATION 8.13 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex: Female, Male Male	341 Participants n=5 Participants	326 Participants n=7 Participants	337 Participants n=5 Participants	324 Participants n=4 Participants	1328 Participants n=21 Participants
Race/Ethnicity, Customized White	337 participants n=5 Participants	325 participants n=7 Participants	334 participants n=5 Participants	321 participants n=4 Participants	1317 participants n=21 Participants
Race/Ethnicity, Customized Black	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Other	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	3 participants n=21 Participants
Total International Prostate Symptom Score (IPSS)	19.0 units on a scale STANDARD_DEVIATION 4.48 • n=5 Participants	18.7 units on a scale STANDARD_DEVIATION 4.63 • n=7 Participants	18.3 units on a scale STANDARD_DEVIATION 4.31 • n=5 Participants	18.6 units on a scale STANDARD_DEVIATION 4.31 • n=4 Participants	18.6 units on a scale STANDARD_DEVIATION 4.44 • n=21 Participants
IPSS voiding score	10.0 units on a scale STANDARD_DEVIATION 3.53 • n=5 Participants	9.8 units on a scale STANDARD_DEVIATION 3.63 • n=7 Participants	9.7 units on a scale STANDARD_DEVIATION 3.61 • n=5 Participants	9.7 units on a scale STANDARD_DEVIATION 3.63 • n=4 Participants	9.8 units on a scale STANDARD_DEVIATION 3.60 • n=21 Participants
IPSS storage score	9.0 units on a scale STANDARD_DEVIATION 2.42 • n=5 Participants	8.9 units on a scale STANDARD_DEVIATION 2.33 • n=7 Participants	8.6 units on a scale STANDARD_DEVIATION 2.39 • n=5 Participants	8.8 units on a scale STANDARD_DEVIATION 2.36 • n=4 Participants	8.8 units on a scale STANDARD_DEVIATION 2.38 • n=21 Participants
IPSS Quality of Life (QoL) score	4.1 units on a scale STANDARD_DEVIATION 1.12 • n=5 Participants	4.1 units on a scale STANDARD_DEVIATION 1.07 • n=7 Participants	4.0 units on a scale STANDARD_DEVIATION 1.15 • n=5 Participants	4.1 units on a scale STANDARD_DEVIATION 1.08 • n=4 Participants	4.1 units on a scale STANDARD_DEVIATION 1.11 • n=21 Participants
Total Urgency Frequency Score (TUFS) (previously known as Total Urgency Score ([TUS])	27.15 units on a scale STANDARD_DEVIATION 8.80 • n=5 Participants	27.85 units on a scale STANDARD_DEVIATION 9.02 • n=7 Participants	26.97 units on a scale STANDARD_DEVIATION 8.66 • n=5 Participants	26.39 units on a scale STANDARD_DEVIATION 8.34 • n=4 Participants	27.09 units on a scale STANDARD_DEVIATION 8.71 • n=21 Participants
Micturitions/24 hours	11.37 micturitions STANDARD_DEVIATION 2.52 • n=5 Participants	11.68 micturitions STANDARD_DEVIATION 2.86 • n=7 Participants	11.48 micturitions STANDARD_DEVIATION 2.61 • n=5 Participants	11.23 micturitions STANDARD_DEVIATION 2.56 • n=4 Participants	11.44 micturitions STANDARD_DEVIATION 2.64 • n=21 Participants
Volume voided/micturition	160.49 mL STANDARD_DEVIATION 47.24 • n=5 Participants	158.80 mL STANDARD_DEVIATION 47.21 • n=7 Participants	160.74 mL STANDARD_DEVIATION 47.60 • n=5 Participants	167.35 mL STANDARD_DEVIATION 50.32 • n=4 Participants	161.82 mL STANDARD_DEVIATION 48.14 • n=21 Participants
Urgency episodes/24 hours	5.47 urgency episodes STANDARD_DEVIATION 3.26 • n=5 Participants	5.51 urgency episodes STANDARD_DEVIATION 3.27 • n=7 Participants	5.28 urgency episodes STANDARD_DEVIATION 3.22 • n=5 Participants	5.18 urgency episodes STANDARD_DEVIATION 3.09 • n=4 Participants	5.36 urgency episodes STANDARD_DEVIATION 3.21 • n=21 Participants
Incontinence episodes/24 hours	1.79 incontinence episodes STANDARD_DEVIATION 2.27 • n=5 Participants	1.82 incontinence episodes STANDARD_DEVIATION 1.73 • n=7 Participants	1.70 incontinence episodes STANDARD_DEVIATION 1.74 • n=5 Participants	1.60 incontinence episodes STANDARD_DEVIATION 2.23 • n=4 Participants	1.73 incontinence episodes STANDARD_DEVIATION 2.03 • n=21 Participants
Urgency incontinence episodes/24 hours	1.62 urgency incontinence episodes STANDARD_DEVIATION 1.86 • n=5 Participants	1.90 urgency incontinence episodes STANDARD_DEVIATION 1.75 • n=7 Participants	1.71 urgency incontinence episodes STANDARD_DEVIATION 1.59 • n=5 Participants	1.60 urgency incontinence episodes STANDARD_DEVIATION 2.24 • n=4 Participants	1.70 urgency incontinence episodes STANDARD_DEVIATION 1.89 • n=21 Participants
Nocturia episodes/24 hours	2.41 nocturia episodes STANDARD_DEVIATION 1.31 • n=5 Participants	2.50 nocturia episodes STANDARD_DEVIATION 1.31 • n=7 Participants	2.37 nocturia episodes STANDARD_DEVIATION 1.19 • n=5 Participants	2.41 nocturia episodes STANDARD_DEVIATION 1.26 • n=4 Participants	2.42 nocturia episodes STANDARD_DEVIATION 1.27 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Full Analysis Set (FAS)-participants who received at least 1 dose of double-blind study drug and had either a total IPSS or TUS at baseline and at least 1 postbaseline total IPSS or TUS. Excluded 5 participants with invalid questionnaires. Last Observation Carried Forward (LOCF) imputation was used.

The International Prostate Symptom Score (IPSS) is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom. Total score can range from 0 to 35 (mildly symptomatic to severely symptomatic).

Outcome measures

Measure	Placebo n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Total International Prostate Symptom Score	-5.4 units on a scale Standard Error 0.41	-6.2 units on a scale Standard Error 0.42	-7.0 units on a scale Standard Error 0.41	-6.5 units on a scale Standard Error 0.42

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: FAS population. LOCF imputation was used.

The Patient Perception of the Intensity of Urgency Scale (PPIUS) is a validated scale completed as part of the micturition diary. For each micturition and/or incontinence episode, the participant rated the degree of associated urgency according to the following 5-point categorical scale: - 0. No urgency; - 1. Mild urgency; - 2. Moderate urgency; - 3. Severe urgency; - 4. Urgency incontinence TUFS was calculated as the sum of the PPIUS gradings from the 3-day diary divided by the number of days on which urgency grading was recorded. Higher scores indicate more severe urgency.

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=295 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=302 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	-4.4 units on a scale Standard Error 0.68	-6.7 units on a scale Standard Error 0.69	-8.1 units on a scale Standard Error 0.67	-7.6 units on a scale Standard Error 0.69

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.

A micturition is any voluntary urination, excluding episodes of incontinence only.The mean number of micturitions per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=317 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=295 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=302 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	-1.1 micturitions Standard Error 0.16	-1.7 micturitions Standard Error 0.16	-2.3 micturitions Standard Error 0.16	-1.9 micturitions Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.

A micturition is any voluntary urination, excluding episodes of incontinence only. The mean volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=317 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=295 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=302 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition	11.1 mL Standard Error 2.94	15.5 mL Standard Error 3.02	38.6 mL Standard Error 2.94	38.7 mL Standard Error 3.01

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment. LOCF imputation was used.

A micturition is any voluntary urination, excluding episodes of incontinence only. The maximum volume voided per micturition was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=317 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=295 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=302 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition	-5.9 mL Standard Error 6.43	-1.8 mL Standard Error 6.62	12.7 mL Standard Error 6.45	12.9 mL Standard Error 6.63

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.

An urgency episode is defined as an episode of strong desire to void accompanied by fear of leakage or pain. The mean number of urgency episodes with PPIUS grade 3 (Severe urgency) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=317 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=295 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=311 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=302 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours	-1.6 urgency episodes Standard Error 0.24	-2.5 urgency episodes Standard Error 0.25	-2.6 urgency episodes Standard Error 0.24	-2.8 urgency episodes Standard Error 0.25

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.

An urgency incontinence episode is defined as an episode with any involuntary leakage of urine accompanied by or immediately preceded by urgency. The mean number of urgency incontinence episodes with PPIUS grade 3 (Severe incontinence) or 4 (Urgency incontinence) per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=86 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=57 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=69 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=80 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours	-1.0 urgency incontinence episodes Standard Error 0.15	-1.4 urgency incontinence episodes Standard Error 0.18	-1.3 urgency incontinence episodes Standard Error 0.16	-1.1 urgency incontinence episodes Standard Error 0.16

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.

An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=89 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=66 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=77 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=86 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	0.1 incontinence episodes Standard Error 0.19	-0.2 incontinence episodes Standard Error 0.22	0.0 incontinence episodes Standard Error 0.20	0.1 incontinence episodes Standard Error 0.19

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.

A nocturia episode is defined as waking up at night to void (i.e., any voiding associated with sleep disturbance between the time the participant goes to bed with the intention to sleep until the time the patient gets up in the morning with the intention to stay awake). The mean number of nocturia episodes per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=282 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=256 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=275 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=271 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours	-0.3 nocturia episodes Standard Error 0.07	-0.4 nocturia episodes Standard Error 0.08	-0.5 nocturia episodes Standard Error 0.07	-0.4 nocturia episodes Standard Error 0.07

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.

The mean number of pads per 24 hours was calculated from data recorded by the participant in the micturition diary for the 3 days preceding each clinic visit.

Outcome measures

Measure	Placebo n=29 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=23 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=30 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=29 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours	-0.7 pads Standard Error 0.23	-0.8 pads Standard Error 0.27	-1.2 pads Standard Error 0.24	-1.2 pads Standard Error 0.24

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The voiding score is the sum of the responses to 4 voiding questions (incomplete emptying of the bladder, intermittency, weak stream, hesitancy) and ranges from 0 to 20 (mildly symptomatic to severely symptomatic).

Outcome measures

Measure	Placebo n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in IPSS Voiding Score	-3.0 units on a scale Standard Error 0.27	-3.3 units on a scale Standard Error 0.28	-3.7 units on a scale Standard Error 0.27	-3.2 units on a scale Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms based on answers to 7 questions concerning urinary symptoms. Each question is assigned points from 0 to 5 indicating increasing severity of the particular symptom. The storage symptom score is the sum of the responses to 3 storage questions (frequency, urgency and nocturia) and ranges from 0 to 15 (mildly symptomatic to severely symptomatic).

Outcome measures

Measure	Placebo n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in IPSS Storage Score	-2.4 units on a scale Standard Error 0.20	-2.9 units on a scale Standard Error 0.20	-3.5 units on a scale Standard Error 0.20	-3.3 units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The QoL assessment was a single question asking the participant how he would feel about tolerating his current level of symptoms for the rest of his life. The answers ranged from 0 to 6 (delighted to terrible).

Outcome measures

Measure	Placebo n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in IPSS QoL Score	-0.9 units on a scale Standard Error 0.11	-1.0 units on a scale Standard Error 0.11	-1.3 units on a scale Standard Error 0.11	-1.3 units on a scale Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The IPSS is a validated global questionnaire to assess the degree of urinary symptoms, based on answers to 7 questions concerning urinary symptoms: •Incomplete emptying of the bladder •Intermittency •Weak stream •Hesitancy •Frequency •Urgency •Nocturia Each question is assigned points from 0 to 5 indicating increasing severity of the symptom.

Outcome measures

Measure	Placebo n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Individual IPSS Scores Incomplete emptying of the bladder	-0.9 units on a scale Standard Error 1.54	-0.9 units on a scale Standard Error 1.52	-1.0 units on a scale Standard Error 1.63	-1.0 units on a scale Standard Error 1.48
Change From Baseline to End of Treatment in Individual IPSS Scores Frequency	-1.0 units on a scale Standard Error 1.36	-1.2 units on a scale Standard Error 1.42	-1.3 units on a scale Standard Error 1.49	-1.4 units on a scale Standard Error 1.41
Change From Baseline to End of Treatment in Individual IPSS Scores Intermittency	-0.9 units on a scale Standard Error 1.41	-0.8 units on a scale Standard Error 1.35	-1.0 units on a scale Standard Error 1.47	-0.7 units on a scale Standard Error 1.34
Change From Baseline to End of Treatment in Individual IPSS Scores Urgency	-1.2 units on a scale Standard Error 1.55	-1.3 units on a scale Standard Error 1.61	-1.4 units on a scale Standard Error 1.51	-1.6 units on a scale Standard Error 1.50
Change From Baseline to End of Treatment in Individual IPSS Scores Hesitancy	-0.5 units on a scale Standard Error 1.37	-0.7 units on a scale Standard Error 1.26	-0.8 units on a scale Standard Error 1.34	-0.7 units on a scale Standard Error 1.29
Change From Baseline to End of Treatment in Individual IPSS Scores Nocturia	-0.5 units on a scale Standard Error 1.23	-0.7 units on a scale Standard Error 1.08	-0.8 units on a scale Standard Error 1.08	-0.6 units on a scale Standard Error 1.15
Change From Baseline to End of Treatment in Individual IPSS Scores Weak stream	-1.1 units on a scale Standard Error 1.54	-1.3 units on a scale Standard Error 1.57	-1.3 units on a scale Standard Error 1.51	-1.3 units on a scale Standard Error 1.56

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

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

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Symptom Bother Score	-11.8 units on a scale Standard Error 1.26	-14.4 units on a scale Standard Error 1.28	-16.5 units on a scale Standard Error 1.26	-17.1 units on a scale Standard Error 1.28

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: - coping - concern - sleep - social interaction Coping score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Health Related QoL (HRQoL) Subscale: Coping Score	8.8 units on a scale Standard Error 1.24	11.0 units on a scale Standard Error 1.26	13.9 units on a scale Standard Error 1.24	13.4 units on a scale Standard Error 1.26

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Concern score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in HRQoL Subscale: Concern Score	7.5 units on a scale Standard Error 1.19	9.3 units on a scale Standard Error 1.21	12.0 units on a scale Standard Error 1.19	11.5 units on a scale Standard Error 1.21

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Sleep score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in HRQoL Subscale: Sleep Score	8.3 units on a scale Standard Error 1.31	8.8 units on a scale Standard Error 1.33	11.9 units on a scale Standard Error 1.31	10.0 units on a scale Standard Error 1.33

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Overactive Bladder Questionnaire (OAB-q) is a self-reported questionnaire with items relating to Symptom Bother and health-related quality of life (HRQoL). The HRQoL portion consists of an 25-item HRQoL subscale containing the following domains scored from 1 to 6: •coping •concern •sleep •social interaction Social score can range from 8 to 48 (none of the time to all of the time) and transformed to a scale from 0 to 100, with higher scores indicating better quality of life. A positive change from baseline indicates an improvement.

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in HRQoL Subscale: Social Score	3.8 units on a scale Standard Error 0.96	4.5 units on a scale Standard Error 0.97	6.2 units on a scale Standard Error 0.95	5.8 units on a scale Standard Error 0.97

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

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

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=312 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in HRQoL Subscale: Total Score	7.4 units on a scale Standard Error 1.06	8.8 units on a scale Standard Error 1.08	11.4 units on a scale Standard Error 1.06	10.7 units on a scale Standard Error 1.08

SECONDARY outcome

Timeframe: Week 12 (end of treatment)

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

A OAB-q responder was defined as a participant with an improvement from baseline in HRQoL subscale total score ≥ 10.

Outcome measures

Measure	Placebo n=314 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=294 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=310 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Percentage of Participants Who Were OAB-q Responders at End of Treatment	40.8 percentage of participants	42.9 percentage of participants	45.5 percentage of participants	47.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = confined to bed).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Mobility Score No problem -> Some problem	16 participants	13 participants	10 participants	13 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No problem -> Confined to bed	0 participants	1 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Some problem -> Some problem	40 participants	31 participants	35 participants	31 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Confined to bed -> No problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Confined to bed -> Confined to bed	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No data -> Some problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No problem -> No problem	240 participants	230 participants	255 participants	233 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No problem -> No data	3 participants	1 participants	1 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Some problem -> No problem	19 participants	21 participants	12 participants	19 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Some problem -> Confined to bed	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Some problem -> No data	0 participants	0 participants	0 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Confined to bed -> Some problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score Confined to bed -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No data -> No problem	0 participants	1 participants	0 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No data -> Confined to bed	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Mobility Score No data -> No data	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to wash/dress).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Self-care Score Unable to wash/ dress -> Some problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No data -> No problem	1 participants	1 participants	1 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No problem -> No problem	295 participants	273 participants	293 participants	286 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No problem -> Some problem	8 participants	8 participants	3 participants	4 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No problem -> Unable to wash/ dress	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No problem -> No Data	3 participants	1 participants	1 participants	4 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Some problem -> No problem	8 participants	6 participants	8 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Some problem -> Some problem	3 participants	8 participants	6 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Some problem -> Unable to wash/ dress	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Some problem -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Unable to wash/ dress -> No problem	0 participants	0 participants	1 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Unable to wash/ dress -> Unable to wash/ dress	0 participants	1 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score Unable to wash/ dress -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No data -> Some problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No data -> Unable to wash/ dress	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Self-care Score No data -> No data	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no problem, 2= some problems, 3 = unable to perform usual activities).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No problem -> Some problem	18 participants	13 participants	14 participants	18 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Some problem -> Unable to perform usual activities	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No data -> Some problem	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No data -> Unable to perform usual activities	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No data -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No problem -> Unable to perform usual activities	0 participants	1 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No problem -> No problem	254 participants	228 participants	248 participants	235 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No problem -> No data	3 participants	1 participants	1 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Some problem -> No problem	21 participants	22 participants	26 participants	27 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Some problem -> Some problem	22 participants	28 participants	22 participants	17 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Some problem -> No data	0 participants	0 participants	0 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Unable to perform usual activities -> No problem	0 participants	1 participants	2 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Unable to perform usual activities -> Some problem	0 participants	1 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Unable to perform usual activities -> same status	0 participants	1 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score Unable to perform usual activities -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Usual Activities Score No data -> No problem	0 participants	2 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= no pain, 2= moderate pain, 3 = extreme pain).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No pain -> No pain	162 participants	159 participants	153 participants	152 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No pain -> Extreme pain	2 participants	1 participants	1 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No pain -> No data	3 participants	0 participants	1 participants	2 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Moderate pain-> Moderate pain	73 participants	72 participants	72 participants	70 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Extreme pain -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No data -> No pain	0 participants	2 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No data -> Moderate pain	2 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No data -> Extreme pain	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No pain -> Moderate pain	14 participants	14 participants	19 participants	24 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Moderate pain-> No pain	55 participants	41 participants	61 participants	41 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Moderate pain-> Extreme pain	2 participants	2 participants	1 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Moderate pain-> No data	0 participants	2 participants	0 participants	2 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Extreme pain -> No pain	0 participants	1 participants	1 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Extreme pain -> Moderate pain	4 participants	2 participants	2 participants	4 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score Extreme pain -> Extreme pain	1 participants	2 participants	2 participants	2 participants
Change From Baseline to End of Treatment in EQ-5D Pain/Discomfort Score No data -> No data	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The European quality of life-5 dimensions (EQ-5D) is an international standardized non-disease specific instrument for describing and valuing health status. The EQ5D has 5 domains: - mobility - self-care - usual activity - pain/discomfort - anxiety/depression Each domain has 3 response levels (1= not anxious, 2= moderately anxious, 3 = extremely anxious).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Not anxious -> Not anxious	219 participants	213 participants	233 participants	214 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Not anxious -> Moderately anxious	16 participants	11 participants	16 participants	18 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Moderately anxious -> Moderately anxious	42 participants	43 participants	39 participants	34 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Extremely anxious -> Moderately anxious	0 participants	0 participants	1 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Not anxious -> Extremely anxious	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Not anxious -> No data	3 participants	0 participants	1 participants	3 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Moderately anxious -> Not anxious	34 participants	25 participants	27 participants	25 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Moderately anxious -> Extremely anxious	1 participants	2 participants	1 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Moderately anxious -> No data	0 participants	1 participants	0 participants	1 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Extremely anxious -> Not anxious	2 participants	0 participants	1 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Extremely anxious -> Extremely anxious	1 participants	2 participants	3 participants	2 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score Extremely anxious -> No data	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score No data -> Not anxious	0 participants	1 participants	1 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score No data -> Moderately anxious	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score No data -> Extremely anxious	0 participants	0 participants	0 participants	0 participants
Change From Baseline to End of Treatment in EQ-5D Anxiety/Depression Score No data -> No data	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

Visual Analogue Scale (VAS) is part of the EQ-5D questionnaire. The VAS is self-rated by the participant ranging from 0 to 100 (worst imaginable health state to best imaginable health state).

Outcome measures

Measure	Placebo n=315 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=311 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=297 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in EQ-5D Visual Analogue Scale (VAS) Score	4.0 units on a scale Standard Deviation 14.48	3.7 units on a scale Standard Deviation 12.69	5.5 units on a scale Standard Deviation 13.58	6.2 units on a scale Standard Deviation 15.52

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Very Much Improved	7 participants	14 participants	20 participants	23 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Much Improved	75 participants	85 participants	95 participants	105 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Minimally Improved	113 participants	99 participants	124 participants	105 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms No Change	86 participants	68 participants	46 participants	38 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Minimally Worse	12 participants	13 participants	2 participants	9 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Much Worse	5 participants	3 participants	0 participants	1 participants
Patient Global Impression Scale at End of Treatment: Overall Bladder Symptoms Very Much Worse	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Patient Global Impression (PGI) is a global questionnaire completed by the participant to assess both the change in the participants overall condition and the change in bladder symptoms since the start of the study. The questionnaire consists of 2 questions with 7 response levels ranging from 1 to 7 (very much improved to very much worse).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Patient Global Impression Scale at End of Treatment: General Health Very Much Improved	5 participants	9 participants	10 participants	7 participants
Patient Global Impression Scale at End of Treatment: General Health Much Improved	43 participants	58 participants	72 participants	75 participants
Patient Global Impression Scale at End of Treatment: General Health Minimally Improved	79 participants	77 participants	87 participants	94 participants
Patient Global Impression Scale at End of Treatment: General Health No Change	152 participants	126 participants	110 participants	94 participants
Patient Global Impression Scale at End of Treatment: General Health Minimally Worse	15 participants	9 participants	8 participants	10 participants
Patient Global Impression Scale at End of Treatment: General Health Much Worse	2 participants	3 participants	0 participants	1 participants
Patient Global Impression Scale at End of Treatment: General Health • Very Much Worse	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: FAS population with data available at both baseline and end of treatment and the exclusion of 5 participants with invalid questionnaires. LOCF imputation was used.

The Clinician Global Impression (CGI) is a questionnaire completed by the physician to assess change in the participants bladder symptoms since the start of the study. The questionnaire consists of 1 question with 7 response levels ranging from 1 to 7 (very much improved to very much worse).

Outcome measures

Measure	Placebo n=318 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=298 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=313 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=301 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Very Much Worse	0 participants	0 participants	0 participants	0 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Very Much Improved	9 participants	15 participants	22 participants	20 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Much Improved	95 participants	106 participants	117 participants	124 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Minimally Improved	111 participants	98 participants	97 participants	92 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms No Change	72 participants	54 participants	48 participants	37 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Minimally Worse	9 participants	5 participants	2 participants	3 participants
Clinician Global Impression Scale at End of Treatment: Overall Bladder Symptoms Much Worse	1 participants	1 participants	1 participants	4 participants

SECONDARY outcome

Timeframe: From first dose of double-blind study drug up to 14 days of last dose of double-blind study drug (up to 14 weeks)

Population: Safety Analysis Set (SAF) - consisted of participants who received at least one dose of double blind study drug and for whom any data was reported after intake of the first dose of study drug.

Safety is monitored by collecting AEs, which include abnormal laboratory parameters, vital signs or ECG data if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE (SAE) was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild (no disruption of normal daily activities), moderate (affected normal daily activities) or severe (inability to perform daily activities) and for causal relationship to study drug. A treatment-emergent adverse event (TEAE) was defined as an AE that occurred after administration of the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug.

Outcome measures

Measure	Placebo n=341 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=326 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=337 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=324 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Number of Participants With Adverse Events (AEs) Moderate TEAEs	25 participants	29 participants	27 participants	27 participants
Number of Participants With Adverse Events (AEs) Total TEAEs	87 participants	74 participants	99 participants	100 participants
Number of Participants With Adverse Events (AEs) Mild TEAEs	59 participants	42 participants	68 participants	68 participants
Number of Participants With Adverse Events (AEs) Severe TEAEs	3 participants	3 participants	4 participants	5 participants
Number of Participants With Adverse Events (AEs) Drug-related TEAEs	30 participants	27 participants	57 participants	65 participants
Number of Participants With Adverse Events (AEs) SAEs	3 participants	10 participants	5 participants	9 participants
Number of Participants With Adverse Events (AEs) Deaths	0 participants	1 participants	1 participants	0 participants
Number of Participants With Adverse Events (AEs) AEs Leading to Discontin	5 participants	9 participants	13 participants	10 participants
Number of Participants With Adverse Events (AEs) Drug-related AEs Leading to Discontin	3 participants	5 participants	9 participants	8 participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: SAF population with at least one baseline and one post-baseline PVR volume measured.

PVR volume is the volume of urine retained after voiding. PVR volume was assessed by ultrasonography or bladder scan.

Outcome measures

Measure	Placebo n=332 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=321 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=329 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=316 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Post Void Residual (PVR) Volume	-6.1 mL Standard Deviation 36.39	-5.0 mL Standard Deviation 38.22	3.8 mL Standard Deviation 45.39	12.3 mL Standard Deviation 46.61

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: SAF population with at least one baseline and one post-baseline micturition episode.

Qmax during a micturition (urination) was recorded using uroflowmetry.

Outcome measures

Measure	Placebo n=306 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=289 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=290 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Maximum Flow Rate (Qmax)	3.3 mL/s Standard Deviation 4.69	3.2 mL/s Standard Deviation 4.62	3.8 mL/s Standard Deviation 5.30	3.5 mL/s Standard Deviation 5.35

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: SAF population with at least one baseline and one post-baseline micturition episode.

Qmean during a micturition (urination) was recorded using uroflowmetry.

Outcome measures

Measure	Placebo n=306 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=288 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=290 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Change From Baseline to End of Treatment in Average Flow Rate (Qmean)	1.5 mL/s Standard Deviation 2.61	1.3 mL/s Standard Deviation 2.16	1.9 mL/s Standard Deviation 2.75	1.7 mL/s Standard Deviation 2.98

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: Pharmacokinetics Analysis Set (PKAS)- randomized participants who received at least 1 dose of double-blind study drug and had at least 1 quantifiable plasma concentration of tamsulosin OCAS and/or solifenacin. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=319 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Apparent Clearance (CL/F) of Tamsulosin Week 4 [N=263; 281; 274]	2.78 L/h Geometric Coefficient of Variation 84.8	2.61 L/h Geometric Coefficient of Variation 85.8	2.53 L/h Geometric Coefficient of Variation 79.3	—
Apparent Clearance (CL/F) of Tamsulosin Week 8 [N=255; 259; 248]	2.62 L/h Geometric Coefficient of Variation 79.0	2.41 L/h Geometric Coefficient of Variation 79.5	2.36 L/h Geometric Coefficient of Variation 93.3	—
Apparent Clearance (CL/F) of Tamsulosin Week 12 [N=163; 167; 166]	2.52 L/h Geometric Coefficient of Variation 85.3	2.40 L/h Geometric Coefficient of Variation 74.1	2.46 L/h Geometric Coefficient of Variation 85.9	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=319 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin Week 4 [N= 263; 281; 274]	7.38 ng/mL Geometric Coefficient of Variation 82.8	7.80 ng/mL Geometric Coefficient of Variation 94.3	8.00 ng/mL Geometric Coefficient of Variation 83.3	—
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin Week 8 [N= 255; 259; 248]	7.69 ng/mL Geometric Coefficient of Variation 71.2	8.32 ng/mL Geometric Coefficient of Variation 73.4	8.46 ng/mL Geometric Coefficient of Variation 84.9	—
Maximum Concentration at Steady State (Cmaxss) of Tamsulosin Week 12 [N= 163; 167; 166]	7.97 ng/mL Geometric Coefficient of Variation 68.6	8.38 ng/mL Geometric Coefficient of Variation 69.0	8.16 ng/mL Geometric Coefficient of Variation 82.7	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=319 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Minimum Concentration at Steady State (Cminss) of Tamsulosin Week 4 [N= 263; 281; 274]	4.19 ng/mL Geometric Coefficient of Variation 127.0	4.55 ng/mL Geometric Coefficient of Variation 146.0	4.75 ng/mL Geometric Coefficient of Variation 124.0	—
Minimum Concentration at Steady State (Cminss) of Tamsulosin Week 8 [N= 255; 259; 248]	4.63 ng/mL Geometric Coefficient of Variation 103.0	5.08 ng/mL Geometric Coefficient of Variation 106.0	5.19 ng/mL Geometric Coefficient of Variation 122.0	—
Minimum Concentration at Steady State (Cminss) of Tamsulosin Week 12 [N= 163; 167; 166]	4.84 ng/mL Geometric Coefficient of Variation 97.7	5.05 ng/mL Geometric Coefficient of Variation 96.2	4.94 ng/mL Geometric Coefficient of Variation 119.0	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=319 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin Week 4 [N= 263; 281; 274]	5.04 h Geometric Coefficient of Variation 4.1	5.06 h Geometric Coefficient of Variation 4.0	5.08 h Geometric Coefficient of Variation 3.6	—
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin Week 8 [N= 255; 259; 248]	5.09 h Geometric Coefficient of Variation 3.4	5.10 h Geometric Coefficient of Variation 3.3	5.11 h Geometric Coefficient of Variation 3.4	—
Time of Maximum Concentration at Steady State (Tmaxss) of Tamsulosin Week 12 [N= 163; 167; 166]	5.10 h Geometric Coefficient of Variation 3.6	5.09 h Geometric Coefficient of Variation 3.6	5.09 h Geometric Coefficient of Variation 3.3	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=305 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=319 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Area Under the Curve at Steady State (AUCss) of Tamsulosin Week 4 [N= 263; 281; 274]	144 ng.h/mL Geometric Coefficient of Variation 96.7	153 ng.h/mL Geometric Coefficient of Variation 111.0	158 ng.h/mL Geometric Coefficient of Variation 96.5	—
Area Under the Curve at Steady State (AUCss) of Tamsulosin Week 8 [N= 255; 259; 248]	153 ng.h/mL Geometric Coefficient of Variation 81.6	166 ng.h/mL Geometric Coefficient of Variation 84.0	169 ng.h/mL Geometric Coefficient of Variation 96.9	—
Area Under the Curve at Steady State (AUCss) of Tamsulosin Week 12 [N= 163; 167; 166]	159 ng.h/mL Geometric Coefficient of Variation 78.1	167 ng.h/mL Geometric Coefficient of Variation 77.4	162 ng.h/mL Geometric Coefficient of Variation 94.8	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=319 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
CL/F of Solifenacin Week 4 [N= 281;273]	6.88 L/h Geometric Coefficient of Variation 53.6	7.00 L/h Geometric Coefficient of Variation 70.7	—	—
CL/F of Solifenacin Week 8 [N= 258; 248]	6.72 L/h Geometric Coefficient of Variation 51.7	6.67 L/h Geometric Coefficient of Variation 61.3	—	—
CL/F of Solifenacin Week 12 [N= 166; 167]	6.94 L/h Geometric Coefficient of Variation 59.3	6.87 L/h Geometric Coefficient of Variation 74.1	—	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=319 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Cmaxss of Solifenacin Week 4 [N= 281; 273]	29.4 ng/mL Geometric Coefficient of Variation 44.8	43.4 ng/mL Geometric Coefficient of Variation 51.4	—	—
Cmaxss of Solifenacin Week 8 [N= 258; 248]	30.0 ng/mL Geometric Coefficient of Variation 48.0	45.3 ng/mL Geometric Coefficient of Variation 48.5	—	—
Cmaxss of Solifenacin Week 12 [N= 166; 167]	29.1 ng/mL Geometric Coefficient of Variation 49.6	44.1 ng/mL Geometric Coefficient of Variation 50.7	—	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=319 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Cminss of Solifenacin Week 4 [N= 281; 273]	24.5 ng/mL Geometric Coefficient of Variation 50.5	36.1 ng/mL Geometric Coefficient of Variation 57.8	—	—
Cminss of Solifenacin Week 8 [N= 258; 248]	25.2 ng/mL Geometric Coefficient of Variation 54.1	38.2 ng/mL Geometric Coefficient of Variation 54.3	—	—
Cminss of Solifenacin Week 12 [N= 166; 167]	24.4 ng/mL Geometric Coefficient of Variation 55.6	37.0 ng/mL Geometric Coefficient of Variation 56.8	—	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=319 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Tmaxss of Solifenacin Week 4 [N= 281; 273]	5.47 h Geometric Coefficient of Variation 1.41	5.47 h Geometric Coefficient of Variation 1.2	—	—
Tmaxss of Solifenacin Week 8 [N= 258; 248]	5.48 h Geometric Coefficient of Variation 0.9	5.48 h Geometric Coefficient of Variation 0.9	—	—
Tmaxss of Solifenacin Week 12 [N= 166; 167]	5.48 h Geometric Coefficient of Variation 0.9	5.48 h Geometric Coefficient of Variation 0.9	—	—

SECONDARY outcome

Timeframe: Week 4, Week 8 and Week 12 (collection time points: trough, 1-3 hours post dose, 4-5 hours post-dose and 7-10 hours post-dose)

Population: PKAS population. "N" indicates the number of participants with available data at each timepoint.

Outcome measures

Measure	Placebo n=319 Participants Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=307 Participants Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
AUCss of Solifenacin Week 4 [N= 281; 273]	657 ng.h/mL Geometric Coefficient of Variation 46.8	970 ng.h/mL Geometric Coefficient of Variation 53.7	—	—
AUCss of Solifenacin Week 8 [N= 258; 248]	673 ng.h/mL Geometric Coefficient of Variation 50.3	1020 ng.h/mL Geometric Coefficient of Variation 50.7	—	—
AUCss of Solifenacin Week 12 [N= 166; 167]	652 ng.h/mL Geometric Coefficient of Variation 51.8	988 ng.h/mL Geometric Coefficient of Variation 53.0	—	—

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

TOCAS 0.4 mg

Serious events: 10 serious events

Other events: 3 other events

Deaths: 0 deaths

FDC 0.4 mg/6 mg

Serious events: 5 serious events

Other events: 36 other events

Deaths: 0 deaths

FDC 0.4 mg/9 mg

Serious events: 9 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=341 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=326 participants at risk Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=337 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=324 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Nervous system disorders Cerebrovascular accident	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Surgical and medical procedures Hip arthroplasty	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Renal and urinary disorders Urinary retention	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.30% 1/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.93% 3/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Angina unstable	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.30% 1/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Coronary artery stenosis	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Sick sinus syndrome	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Angina pectoris	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Atrial fibrillation	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.61% 2/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Atrial flutter	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Myocardial infarction	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Cardiac disorders Tachycardia	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.30% 1/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Nervous system disorders Syncope	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Infections and infestations Bronchiectasis	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.30% 1/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Psychiatric disorders Depression	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.30% 1/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Eye disorders Cataract	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Gastrointestinal disorders Inguinal hernia	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Gastrointestinal disorders Intestinal ischaemia	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Hepatobiliary disorders Cholecystitis acute	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Hepatobiliary disorders Cholelithiasis	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Investigations Alanine aminotransferase increased	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Investigations Aspartate aminotransferase increased	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Investigations Blood alkaline phosphatase increased	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Investigations Gamma-glutamyltransferase increased	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Surgical and medical procedures Cataract operation	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Surgical and medical procedures Gallbladder operation	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Vascular disorders Hypertension	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Vascular disorders Varicose vein	0.00% 0/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.00% 0/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population

Other adverse events

Measure	Placebo n=341 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	TOCAS 0.4 mg n=326 participants at risk Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/6 mg n=337 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet	FDC 0.4 mg/9 mg n=324 participants at risk Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
Gastrointestinal disorders Constipation	0.29% 1/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.31% 1/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	3.6% 12/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	5.6% 18/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population
Gastrointestinal disorders Dry mouth	1.2% 4/341 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	0.61% 2/326 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	8.6% 29/337 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population	10.5% 34/324 • From the first dose of double-blind study drug until 14 days after the last dose of double-blind study drug, up to 14 weeks. SAF population

Additional Information

Medical Director, Global Medical Science

Astellas Pharma Europe B.V.

Email: Astellas.resultsdisclosure@astellas.com

Results disclosure agreements

• Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 3 months prior to publication for review and comment. Sponsor may delay the publication to seek patent protection.
• Publication restrictions are in place

Restriction type: OTHER