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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
8
IGRT with VESIcare
IGRT with placebo
Century Cancer Center
Houston, Texas, United States
Change From Baseline to End of Study Measured by the American Urology Association Symptom Score Questionnaire (AUASS).
The AUASS score range is 1-7 (mild), 8-19 (moderate) and 20-35 (severe). The AUASS asks 7 questions scored 0-5, the scores are summed for the total score.
Time frame: baseline and 16 weeks
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