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

Last updated: October 22, 2018
Sponsor: NICHD Pelvic Floor Disorders Network
Overall Status: Completed

Phase

3

Condition

Rectal Disorders

Bowel Dysfunction

Fecal Incontinence

Treatment

N/A

Clinical Study ID

NCT02008565
PFDN- 18PO1
1U01HD069031
1U10HD069006
2U10HD054214
2U10HD041261
1U10HD069013
1U10HD069025
2U10HD041267
1U10HD069010
2U10HD054215
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥18 years

  • Fecal incontinence defined as any uncontrolled loss of liquid or solid fecal materialthat occurs at least monthly over the last 3 months that is bothersome enough todesire treatment

Exclusion

Exclusion Criteria:

  • Stool consistency over the last 3 months that includes items 1 or 7 based on theBristol Stool form scale

  • Current or past diagnosis of colorectal or anal malignancy

  • Diagnosis of inflammatory bowel disease

  • Current or history of rectovaginal fistula or cloacal defect

  • Rectal prolapse (mucosal or full thickness)

  • Prior removal or diversion of any portion of colon or rectum

  • Prior pelvic floor or abdominal radiation

  • Refusal or inability to provide written consent

  • Inability to conduct telephone interviews conducted in English or Spanish

  • Fecal impaction by exam

  • Untreated pelvic organ prolapse beyond the hymen; Patients with prolapse beyond thehymen who are currently using a pessary are eligible

  • Incontinence only to flatus

  • Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in thelast 30 days

  • Previously received and failed treatment of fecal incontinence using loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) over the last 3 months

  • Current supervised anal sphincter exercise/pelvic floor muscle training withbiofeedback

  • Previously received and failed treatment of fecal incontinence using supervised analsphincter exercise/pelvic floor muscle training with biofeedback

  • Previous allergy or intolerance to loperamide

  • Pregnant, nursing, or planning to become pregnant before the end of the studyfollow-up period.

  • Childbirth within the last 3 months

  • Currently taking anti-retroviral drugs

  • Neurological disorders known to affect continence, including spinal cord injury,advanced multiple sclerosis or Parkinson's disease and debilitating stroke

  • Known diagnosis of hepatic impairment

  • Chronic abdominal pain in the absence of diarrhea

Study Design

Total Participants: 300
Study Start date:
February 01, 2014
Estimated Completion Date:
May 31, 2016

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • University of California at San Diego

    La Jolla, California 92037-0974
    United States

    Site Not Available

  • Kaiser San Diego

    San Diego, California 92110
    United States

    Site Not Available

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27707
    United States

    Site Not Available

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19118
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Brown/Women and Infants Hospital of Rhode Island

    Providence, Rhode Island 02903
    United States

    Site Not Available

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