At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 640 enrolled
Drug / intervention
solifenacin succinate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating solifenacin succinate and Placebo for Urinary Incontinence. Completed, enrolled 640 participants across 60 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Incontinence
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJun 2011
Enrollment StartAug 2011
Primary CompletionOct 2013
TodayJul 2026
First PostedJun 13, 2011
Enrollment StartAug 2, 2011
Primary CompletionOct 21, 2013
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 15.1 years ago
Interventions
solifenacin succinatedrug
oral
Placebodrug
oral