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
- 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
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