A Study to Assess Efficacy and Safety With VESIcare® to Improve Urinary Continence in 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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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 time from the date of first dose to the date of urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Urinary continence will be defined as the first of three consecutive 24 hour days which subject uses 0 pads, or a pad for security which remains completely dry, during the 12 week study
- Proportion of subjects who gain urinary continence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline to each month in average daily pad usage [ Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in quality of life (QOL) [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]QOL as measured by the American Urology Association Symptom Score (AUASS)
- Change from baseline in quality of life (QOL) [ Time Frame: Bsaeleine and 12 weeks ] [ Designated as safety issue: No ]QOL as measured by the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF)
- Change from baseline to end of study on work productivity [ Time Frame: Baseline and 12 weeks ] [ Designated as safety issue: No ]Work productivity will be measured by the Work Productivity and Activity Impairment Questionnaire (WPAI)
- Time from baseline to first day of returning to work [ Time Frame: Baseline and up to 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
|Experimental: solifenacin succinate||
Drug: solifenacin succinate
|Placebo Comparator: Placebo||
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.
Subjects will complete an electronic daily pad use diary during the study duration. Subjects will also be asked to complete several questionnaires during the study.
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|Study Director:||Medical Director||Astellas Pharma Global Development|