Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Intervention: Loperamide; Placebo; Anal exercises with biofeedback; Usual Care
Intervention description: Participants randomized to the loperamide group will begin with 2mg of loperamide/day. The participant will be administered the Patient Global Symptom Control rating scale (PGSC) to determine dose escalation. Participants who report inadequate control of stool leakage on the PGSC will be instructed to increase the daily dose of loperamide by 2 mg up to a maximum of 8 mg per day (1-4 capsules). Bothersome adverse events and resulting dose reduction will be based exclusively on the result of the Patient Global Tolerability Scale (PGTS). The daily dose will be decreased by 2mg to a minimum of 2mg every other day. If a PGSC score indicates inadequate control of stool leakage combined with a PGTS score indicating bothersome side effects, the participant will discontinue the study medication.; Participants randomized to the placebo arm will begin the a dose of one capsule per day and will be dose increased or dose decreased using the same algorithm described for the loperamide arm.; Participants will receive a formal anal exercises training program that can be easily applied in an office setting with minimal participant burden. Participants will attend six anal exercises with biofeedback sessions with trained personnel over a 12-week period for the 24-week study. Sessions will include introduction, standard patient education, and exercises using anal manometry-assisted biofeedback introducing concepts such as shaping, generalization and termination. The protocol uses strength and sensory training including urge resistance training. During the final twelve weeks, participants will perform anal exercises on their own. The sessions with interventionists will occur every other week for 12 weeks (total 6 supervised sessions).; Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases.
Intervention MeSH terms: Loperamide; Antidiarrheals
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fecal incontinence; Loperamide; anal exercises; biofeedback

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 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