Biofeedback + Injection for Bowel Incontinence
Trial Summary
Will I have to stop taking my current medications?
Participants must stop using over-the-counter medications, herbal supplements, or prescribed medications for modifying stool consistency, unless they are on the approved list (loperamide, laxatives, fiber supplements, and Questran).
What data supports the effectiveness of the treatment Biofeedback + Injection for Bowel Incontinence?
Research shows that biofeedback, a technique that helps patients gain control over certain bodily functions, is effective in treating fecal incontinence by improving patients' quality of life and enabling them to manage their condition better. It has been successfully used for both fecal and urinary incontinence, suggesting its potential benefit in bowel incontinence treatment.12345
How does the Biofeedback + Injection treatment for bowel incontinence differ from other treatments?
This treatment combines biofeedback, which helps patients learn to control their bowel muscles, with injections that add bulk to the anal canal, potentially offering a more comprehensive approach than using either method alone. Biofeedback is a non-invasive technique that can be done at home, while the injection provides a physical change to support continence.12467
What is the purpose of this trial?
This trial is for patients with severe fecal incontinence who haven't responded to initial treatments. It compares two methods: muscle training and a treatment that adds bulk to the rectum. The goal is to see which method better reduces incontinence episodes.
Research Team
Adil Bharucha, MBBS, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
Adults with severe fecal incontinence, experiencing more than two episodes per week despite 4 weeks of conservative treatment. Participants must be able to walk independently and have had a physician's diagnosis for at least six months. Exclusions include significant anal pain or injuries, certain anatomic limitations, allergies to specific products, pregnancy plans within two years, and various medical conditions like inflammatory bowel disease or neurological disorders.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Enhanced Medical Management (EMM)
Participants receive education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency
Randomized Treatment
Participants are randomized to either Biofeedback (BIO) or Injection (INJ) treatment
Combination Therapy
Participants who do not achieve a 75% reduction in FI frequency may choose an additional treatment
Long-term Follow-up
Participants are monitored for safety, efficacy, and quality of life outcomes
Treatment Details
Interventions
- Biofeedback
- Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
University of Michigan
Collaborator
University of Alabama at Birmingham
Collaborator
RTI International
Collaborator
University of North Carolina, Chapel Hill
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Colon and Rectal Surgery Associates, Ltd.
Collaborator
Augusta University
Collaborator