NCT01371994

A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The study duration includes a 14-day treatment free wash-out period. The maximum total study duration is 15 weeks (2-3 week screening/washout period and a 12 week treatment period). The Baseline, Week 4, and Week 8 visits will be telephone contact visits. Participants will complete an electronic daily pad use diary during the study duration. Participants will also be asked to complete several questionnaires during the study.

Conditions

• Urinary Incontinence

Interventions

Type	Name	Description
DRUG	solifenacin succinate	oral
DRUG	Placebo	oral

Timeline

• Start date: 2011-08-02
• Primary completion: 2013-10-21
• Completion: 2013-10-21
• First posted: 2011-06-13
• Last updated: 2024-11-21
• Results posted: 2014-10-09

Locations

60 sites across 2 countries: United States, Canada