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

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NICHD Pelvic Floor Disorders Network
• Collaborators: Duke University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH); RTI International; The Cleveland Clinic; University of Alabama at Birmingham; University of California, San Diego; University of New Mexico; University of Pennsylvania; University of Pittsburgh; Women and Infants Hospital of Rhode Island
• Treatments: Antidiarrheals; Loperamide

Criteria

Inclusion Criteria:

• Age ≥18 years

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

Exclusion Criteria:

• Stool consistency over the last 3 months that includes items 1 or 7 based on the Bristol 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 the hymen who are currently using a pessary are eligible

• Incontinence only to flatus

• Has taken any loperamide (Imodium®) or diphenoxylate plus atropine (Lomotil®) in the last 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 with biofeedback

• Previously received and failed treatment of fecal incontinence using supervised anal sphincter 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 study follow-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