Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Status:
Completed
Trial end date:
2016-05-01
Target enrollment:
Participant gender:
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
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