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Solifenacin for Incontinence After Robotic Assisted Radical Prostatectomy
NCT01371994Phase 4
Key facts
- Status
- Completed
- Start
- Aug 2011
- Primary completion
- Oct 2013
- Countries
- 2
- Sponsor
- Astellas Pharma
- Modality
- Orthosteric Ligands
- Drugs
- solifenacin
- Conditions
- urinary incontinence (UI)
01
Overview
Phase 4, randomised, double-blind trial in urinary incontinence (UI) comparing Solifenacin succinate with Placebo (2 arms). Primary endpoint: Time From First Dose to Urinary Continence at 12 weeks. Started Aug 2011; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Solifenacin succinate
5 mg once daily, potentially increased to 10 mg at Week 4
Placebo
Matching placebo once daily
03
Who it enrols
Men diagnosed with prostate cancer treated by Robotic Assisted Radical Prostatectomy who have urinary incontinence (2-10 pads/day) and are voiding spontaneously.
04
Endpoints
Primary
Time From First Dose to Urinary Continence
Secondary
Percentage of Participants Who Gain Continence During 12-week Treatment Period
Change From Baseline in Average Daily Pad Usage
Change From Baseline in American Urology Association Symptom Score
Change From Baseline in International Consultation on Incontinence Questionnaire Short Form QOL Score
Change From Baseline in Work Productivity and Activity Impairment
05
Results
Not all primary endpoints met
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