drugset / Trial / NCT00862745

Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)

NCT00862745

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2009-01
Primary completion
2010-05
Completion
2011-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fesoterodine Other / unclassified 4 mg Oral
Subject Fesoterodine Other / unclassified 8 mg Oral

Indications