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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Change from baseline to end of study measured by the American Urology Association Symptom Score Questionnaire (AUASS).
baseline and 12 weeks
Sanjay Mehta, M.D.
Century Cancer Centers
United States: Food and Drug Administration
|Century Cancer Center||Greenwood Village, Colorado 80111|
|Century Cancer Center||Houston, Texas 77025|