drugset / Trial / NCT00862745
Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
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
Publications
- Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
- Warsi QA, Huang AJ, Hess R, Arya LA, Richter HE, Bradley CS, Rogers RG, Myers DL, Johnson KC, Winkelman WD, Gregory WT, Kraus SR, Schembri M, Brown JS, Stone KL, Subak LL. Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness. Obstet Gynecol. 2018 Feb;131(2):204-211. doi: 10.1097/AOG.0000000000002443.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fesoterodine | Other / unclassified | 4 mg | Oral |
| Subject | Fesoterodine | Other / unclassified | 8 mg | Oral |