Biofeedback + Injection for Bowel Incontinence
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new treatments for individuals with severe bowel incontinence, characterized by frequent accidents or leakage. Participants will initially undergo a four-week program involving education and exercises to determine if it reduces these episodes. If not, they will receive one of two treatments: biofeedback (a technique to improve muscle control) or an injection to strengthen the rectal area. The trial aims to identify which approach more effectively reduces incontinence and enhances quality of life. It seeks participants who have experienced bowel incontinence for six months or more and have at least two episodes per week, despite trying some self-care methods. As an unphased trial, this study provides a unique opportunity to contribute to developing new solutions for bowel incontinence.
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).
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that biofeedback yields positive results for treating fecal incontinence, with over 70% of patients experiencing short-term improvement. This indicates that biofeedback is generally well-tolerated, although results can vary.
Research on injections using bulking agents like Solesta has shown them to be safe and effective in reducing symptoms of fecal incontinence. These injections are minimally invasive and typically cause only minor side effects, such as slight discomfort or swelling at the injection site.
Both biofeedback and injection treatments have good safety records. Extensive studies have generally considered them safe for people, with few serious side effects reported.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for bowel incontinence, which often include medications and surgery, this trial combines biofeedback and an injection technique to offer a potentially more immediate and less invasive solution. Biofeedback is unique because it trains patients to gain better control over their bowel function through guided exercises, while the injection uses a bulking agent to physically support rectal walls, reducing leaks. Researchers are excited because this dual approach could provide quicker and more sustainable relief by addressing both the muscular and structural aspects of the condition.
What evidence suggests that this trial's treatments could be effective for bowel incontinence?
Research has shown that biofeedback, which participants in this trial may receive, can effectively treat fecal incontinence (FI). Many patients who try biofeedback experience lasting improvements in their symptoms. For example, one study found that 88.9% of patients continued to feel better over the long term. In contrast, another treatment option in this trial involves injections with bulking agents like Solesta. These injections have helped people who haven't had success with standard treatments. The bulking agent works by making the rectum opening smaller, which can help reduce incontinence episodes.14678
Who Is on the Research Team?
Adil Bharucha, MBBS, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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