NCT01777217

VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

A Pilot Study to Assess the Safety and Efficacy of Solifenacin (VESIcare) for Improving Urinary and Bladder Functions in Patients Undergoing Radiation Therapy of the Prostate

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Advanced Research Network · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if Vesicare (Solifenacin succinate) is effective in treating over-active bladder symptoms during radiation therapy of the prostate.

Detailed description

This is a randomized double blind placebo controlled flexible dose 12 week study. Following screening, subjects will receive their first dose of study medication following completion of AUASS questionnaire on the first day of radiation treatment (baseline) and will continue for twelve weeks. Subjects will be started on 5 mg of study medication. The AUASS will be completed at baseline, weeks 4, 8 and 12. A 16 week visit conducted over a phone interview.

Conditions

• Over-Active Bladder

Interventions

Type	Name	Description
DRUG	Solifenacin succinate	IGRT with VESIcare
DRUG	Placebo	IGRT with placebo

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-01-28
• Last updated: 2015-01-16
• Results posted: 2015-01-16

Locations

1 site across 1 country: United States