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A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in Subjects After Robotic Assisted Radical Prostatectomy


A Randomized, Double-Blind, Parallel, Placebo-Controlled, Phase 4, Multicenter Study to Assess Efficacy and Safety of VESIcare® (Solifenacin Succinate) to Improve Urinary Continence of Subjects After Robotic Assisted Radical Prostatectomy




The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment of VESIcare® versus placebo in subjects who are incontinent after Robotic Assisted Radical Prostatectomy. This study will also assess the effect of 12 weeks of treatment with VESIcare versus placebo on quality of life (QOL) as measured by questionnaires.

Study Status: Completed


Condition Intervention Phase
Urinary Incontinence Drug: solifenacin succinate
Drug: Placebo
Phase 4

Verified by Astellas Pharma Inc November, 2013

Sponsored by: Astellas Pharma Inc
Information provided by: Astellas Pharma Inc identifier: NCT01371994

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

Medical Director., Study Director

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