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

NICHD Pelvic Floor Disorders Network

Status and phase: Completed; Phase 3

Conditions: Fecal Incontinence

Treatments: Behavioral: Usual Care; Behavioral: Anal exercises with biofeedback; Drug: Loperamide; Drug: Placebo

Study type: Interventional

Funder types: Other; NETWORK; NIH

Identifiers

NCT02008565

1U10HD069013 (U.S. NIH Grant/Contract)

1U10HD069025 (U.S. NIH Grant/Contract)

2U10HD041267 (U.S. NIH Grant/Contract)

2U10HD054214 (U.S. NIH Grant/Contract)

2U10HD041261 (U.S. NIH Grant/Contract)

1U10HD069010 (U.S. NIH Grant/Contract)

1U01HD069031 (U.S. NIH Grant/Contract)

2U10HD054215 (U.S. NIH Grant/Contract)

1U10HD069006 (U.S. NIH Grant/Contract)

PFDN- 18PO1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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300 participants in 4 patient groups, including a placebo group

Placebo - Exercise plus Biofeedback

Placebo Comparator group

Description:

Placebo and biofeedback intervention. Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.

Treatment:

Behavioral: Anal exercises with biofeedback

Drug: Placebo

Loperamide - Exercise plus Biofeedback

Experimental group

Description:

Loperamide and biofeedback intervention. Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Anal exercises with biofeedback intervention is a total of six sessions with trained personnel occurring every 2 weeks over a 12-week period. Sessions are held at the following study visits: baseline, 2, 4, 6, 9, and 12 week visits.

Treatment:

Behavioral: Anal exercises with biofeedback

Drug: Loperamide

Placebo - Education Only

Placebo Comparator group

Description:

Placebo and education (usual care). Placebo doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet.

Treatment:

Drug: Placebo

Behavioral: Usual Care

Loperamide - Education Only

Experimental group

Description:

Loperamide and education (usual care). Loperamide doses range from 2mg every other day to 8mg per day. Capsules are taken by mouth once a day for 24 weeks. Participants receive education and a NIDDK Bowel Control Educational pamphlet.

Treatment:

Drug: Loperamide

Behavioral: Usual Care