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

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

Outcome

Missed primary endpoint

registry analysis (superiority test); Loperamide - Exercise Plus Biofeedback vs Placebo - Exercise Plus Biofeedback; p = 0.092; Mixed Models Analysis; note: significance assessed at type 1 error alpha=0.05 NCT02008565 ↗

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

Indications

No indication recorded.