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

Fecal Incontinence Clinical Trial

Official title: Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe): a Randomized Placebo Controlled Trial

Status Completed

Clinical Trial 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.

Clinical Trial Description

The goals of this trial are to compare the use of loperamide to oral placebo and to compare the use of anal sphincter exercise training with biofeedback to usual care (educational pamphlet) in the treatment of women suffering from fecal incontinence (FI). We will test the following null hypotheses:

1. there is no difference in outcomes between women randomized to loperamide and women randomized to oral placebo for treatment of FI;

2. there is no difference in outcomes between women randomized to anal sphincter exercises with biofeedback and women randomized to usual care (educational pamphlet) for FI treatment;

3. there is no difference between women randomized to both treatments together and women randomized to either FI treatment alone; and

4. there is no correlation between anal manometry measurements and digital anal squeeze strength or measures of FI severity and bother.

A supplemental study, Stool Metabolome and Microbiome in Women with Fecal Incontinence in CAPABLe, will evaluate the stool metabolome and microbiome in women with fecal incontinence and unaffected age matched controls. ;

Related Conditions & MeSH terms

• Fecal Incontinence

• NCT number: NCT02008565
• Study type: Interventional
• Source: NICHD Pelvic Floor Disorders Network
• Status: Completed
• Phase: Phase 3
• Start date: February 2014
• Completion date: May 2016