At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe): a Randomized Placebo Controlled Trial
In Brief
A Phase 3 clinical trial evaluating Loperamide, Placebo, and 2 other interventions for Fecal Incontinence. Completed, enrolled 300 participants across 9 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.