Trial · NCT01018511

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

NCT01018511, Phase 3, Completed, Astellas Pharma Europe B.V.; results first posted 2015-12-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms. Trials, record NCT01018511. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01018511

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Solifenacin Succinate and Tamsulosin Hydrochloride OCAS in Males With Lower Urinary Tract Symptoms
NCT number: NCT01018511
Status: Completed
Phases: Phase 3
Enrollment: 1,334 participants, actual
Lead sponsor: Astellas Pharma Europe B.V.
Conditions: Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Interventions: Placebo tamsulosin hydrochloride OCAS 0.4 mg, Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg, Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg, tamsulosin hydrochloride OCAS 0.4 mg, tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/6 mg), tamsulosin hydrochloride/solifenacin succinate fixed dose combination (0.4 mg/9 mg)
First posted: 2009-11-23
Last updated: 2024-12-03
Other registries' IDs: eudract:2008-001211-37
Results first posted: 2015-12-17
Limitations and caveats: Company makes no warranties or representations of any kind as to the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose, and shall not be liable for any damages.

Source ClinicalTrials.gov

Registered outcomes44

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to End of Treatment in Total International Prostate Symptom Score	Baseline and Week 12	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).
Primary	Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours	Baseline and Week 12	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.
Secondary	Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours	Baseline and Week 12	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.

1 to 10 of 44Source ClinicalTrials.gov

See all 44 registered outcomes

Outcomes44

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to End of Treatment in Total International Prostate Symptom Score	Baseline and Week 12	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.	units on a scale	LEAST_SQUARES_MEAN
PRIMARY	Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	Baseline and Week 12	FAS population. LOCF imputation was used.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	Baseline and Week 12	FAS population with data available at both baseline and end of treatment. LOCF imputation was used.	micturitions	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Voided Volume Per Micturition	Baseline and Week 12	FAS population with data available at both baseline and end of treatment. LOCF imputation was used.	mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Maximum Volume Voided Per Micturition	Baseline and Week 12	FAS population with data available at both baseline and end of treatment. LOCF imputation was used.	mL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Urgency Episodes (PPIUS Grade 3 or 4) Per 24 Hours	Baseline and Week 12	FAS population and at least 1 urgency episode at baseline. LOCF imputation was used.	urgency episodes	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours	Baseline and Week 12	FAS population and at least 1 urgency incontinence episode at baseline. LOCF imputation was used.	urgency incontinence episodes	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours	Baseline and Week 12	FAS population and at least 1 incontinence episode at baseline. LOCF imputation was used.	incontinence episodes	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Nocturia Episodes Per 24 Hours	Baseline and Week 12	FAS population and at least 1 nocturia episode at baseline. LOCF imputation was used.	nocturia episodes	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to End of Treatment in Mean Number of Pads Used Per 24 Hours	Baseline and Week 12	FAS population and at least 1 use of a pad at baseline. LOCF imputation was used.	pads	LEAST_SQUARES_MEAN

1 to 10 of 44Source ClinicalTrials.gov

See all 44 outcomes

Results by group639

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to End of Treatment in Total International Prostate Symptom Score	Placebo	-5.4	Standard Error 0.41	units on a scale
Change From Baseline to End of Treatment in Total International Prostate Symptom Score	TOCAS 0.4 mg	-6.2	Standard Error 0.42	units on a scale
Change From Baseline to End of Treatment in Total International Prostate Symptom Score	FDC 0.4 mg/6 mg	-7.0	Standard Error 0.41	units on a scale
Change From Baseline to End of Treatment in Total International Prostate Symptom Score	FDC 0.4 mg/9 mg	-6.5	Standard Error 0.42	units on a scale
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	Placebo	-4.4	Standard Error 0.68	units on a scale
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	TOCAS 0.4 mg	-6.7	Standard Error 0.69	units on a scale
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	FDC 0.4 mg/6 mg	-8.1	Standard Error 0.67	units on a scale
Change From Baseline to End of Treatment in Total Urgency Frequency Score (TUFS, Previously Known as Total Urgency Score [TUS])	FDC 0.4 mg/9 mg	-7.6	Standard Error 0.69	units on a scale
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	Placebo	-1.1	Standard Error 0.16	micturitions
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours	TOCAS 0.4 mg	-1.7	Standard Error 0.16	micturitions

1 to 10 of 639Source ClinicalTrials.gov

See all 639 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	341
Overall Study	STARTED	TOCAS 0.4 mg	327
Overall Study	STARTED	FDC 0.4 mg/6 mg	339
Overall Study	STARTED	FDC 0.4 mg/9 mg	327
Overall Study	Randomized and Treated	Placebo	341
Overall Study	Randomized and Treated	TOCAS 0.4 mg	326
Overall Study	Randomized and Treated	FDC 0.4 mg/6 mg	338
Overall Study	Randomized and Treated	FDC 0.4 mg/9 mg	324
Overall Study	COMPLETED	Placebo	315
Overall Study	COMPLETED	TOCAS 0.4 mg	295

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Constipation	Gastrointestinal disorders	Placebo	1	341
other	Constipation	Gastrointestinal disorders	TOCAS 0.4 mg	1	326
other	Constipation	Gastrointestinal disorders	FDC 0.4 mg/6 mg	12	337
other	Constipation	Gastrointestinal disorders	FDC 0.4 mg/9 mg	18	324
other	Dry mouth	Gastrointestinal disorders	Placebo	4	341
other	Dry mouth	Gastrointestinal disorders	TOCAS 0.4 mg	2	326
other	Dry mouth	Gastrointestinal disorders	FDC 0.4 mg/6 mg	29	337
other	Dry mouth	Gastrointestinal disorders	FDC 0.4 mg/9 mg	34	324
serious	Urinary retention	Renal and urinary disorders	Placebo	1	341
serious	Urinary retention	Renal and urinary disorders	TOCAS 0.4 mg	1	326

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	TOCAS 0.4 mg
Total, all-cause mortality	FDC 0.4 mg/6 mg
Total, all-cause mortality	FDC 0.4 mg/9 mg
Total, other adverse events	Placebo	5	341
Total, other adverse events	TOCAS 0.4 mg	3	326
Total, other adverse events	FDC 0.4 mg/6 mg	36	337
Total, other adverse events	FDC 0.4 mg/9 mg	43	324
Total, serious adverse events	Placebo	3	341
Total, serious adverse events	TOCAS 0.4 mg	10	326

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23932438	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01018511

GET https://conductscience.org/api/trials/v1/NCT01018511/registered?page=2

API reference For AI assistants