A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.

Phase 4

Completed

• Conditions: Urinary Incontinence
• Interventions: Drug: tamsulosin; Drug: solifenacin succinate; Drug: placebo

• Registration Number: NCT00333112
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.

Detailed Description

A 2 arm study ( 1 Active, 1 Placebo) to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 398

Inclusion Criteria

• Symptoms of Overactive Bladder (OAB)

Exclusion Criteria

• Current use of antimuscarinic therapy
• Evidence of a urinary tract infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
2	tamsulosin	-
1	solifenacin succinate	-
1	tamsulosin	-

Primary Outcome Measures

Name	Time	Method
Change in micturitions per 24 hours from baseline to end of treatment	18 weeks

Secondary Outcome Measures

Name	Time	Method
Change in urgency episodes per 24 hours from baseline to end of treatment	18 weeks