Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)

NCT02008565 ↗

Phase 3 Completed 300 enrolled NICHD Pelvic Floor Disorders Network Duke University · collab Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab National Institutes of Health (NIH) · collab RTI International · collab The Cleveland Clinic · collab University of Alabama at Birmingham · collab University of California, San Diego · collab University of New Mexico · collab University of Pennsylvania · collab University of Pittsburgh · collab Women and Infants Hospital of Rhode Island · collab

RandomizedFactorialQuadruple-blindTreatment

Summary

The study is a multi-center, randomized, placebo controlled trial with participants randomized into one of four groups: 1. placebo/usual care (educational pamphlet) 2. loperamide/usual care (educational pamphlet) 3. placebo/anal exercises with biofeedback 4. loperamide/anal exercises with biofeedback The primary outcome, change from baseline in St. Marks (Vaizey) Score at 24 weeks, will be compared between treatment groups using linear regression.

Timeline

Start: 2014-02
Primary completion: 2016-05
Completion: 2016-05

Publications

Jelovsek JE, Markland AD, Whitehead WE, Barber MD, Newman DK, Rogers RG, Dyer K, Visco AG, Sutkin G, Zyczynski HM, Carper B, Meikle SF, Sung VW, Gantz MG; National Institute of Child Health and Human Development Pelvic Floor Disorders Network. Controlling faecal incontinence in women by performing anal exercises with biofeedback or loperamide: a randomised clinical trial. Lancet Gastroenterol Hepatol. 2019 Sep;4(9):698-710. doi: 10.1016/S2468-1253(19)30193-1. Epub 2019 Jul 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Loperamide	Small molecule	2 mg	Oral

Indications

No indication recorded.