Overactive Bladder Clinical Trial
Official title:
A Multi-center, Randomized, Placebo-controlled Clinical Trial Comparing Fesoterodine to Placebo in Women Diagnosed With Urge Urinary Incontinence by the 3 Incontinence Questions (3IQ). Followed by a Multi-center Open Label Clinical Cohort Study of Long-term Effects of Treatment With Fesoterodine.
Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a
three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of
fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in
the US. All participants who complete the 12-week randomized trial will be offered
open-label fesoterodine for an additional 9 months.
The hypothesis of the randomized controlled trial is that among women diagnosed with urge
incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean
number of urge incontinence episodes per day.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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