Biofeedback + Injection for Bowel Incontinence

Recruiting at 5 trial locations

Overseen By Marie Gantz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Immunotherapy, Chemotherapy

Disqualifiers: Dementia, Pregnancy, Spinal cord injury, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

275 Participants Needed

What You Need to Know Before You Apply

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.

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).

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. ^{1 2 3 4 5}

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. ^{1 3 4 6 7}

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

I have been diagnosed with fecal incontinence for 6 months or more.

I qualify for dextranomer treatment except for a minor internal anal sphincter defect.

My conservative treatment for FI didn't reduce episodes by 75% after 4 weeks.

Exclusion Criteria

I have had pelvic radiation in the last year or have active inflammation of the rectum due to radiation.

Patients who cannot expel the rectal balloon during the balloon expulsion test and who have constipation most of the time

Anatomic limitations to placement of dextranomer injections

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Daily symptom diary

Enhanced Medical Management (EMM)

Participants receive education, pelvic floor exercises, and use of non-prescription drugs to normalize stool consistency

4 weeks

1 visit (in-person)

Randomized Treatment

Participants are randomized to either Biofeedback (BIO) or Injection (INJ) treatment

6 weeks

5-6 visits (in-person) for BIO, 2 visits (in-person) for INJ

Combination Therapy

Participants who do not achieve a 75% reduction in FI frequency may choose an additional treatment

Up to 24 months

Long-term Follow-up

Participants are monitored for safety, efficacy, and quality of life outcomes

24 months

Follow-up assessments at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Biofeedback
• Injection

Trial Overview The FIT Study is testing the effectiveness of Biofeedback versus Injection of Solesta after initial Enhanced Medical Management fails to reduce fecal incontinence by 75%. Patients who don't improve sufficiently will be randomized into one of these treatments and followed up for efficacy, safety, and cost over a total period of 24 months.

How Is the Trial Designed?

Group I: Biofeedback (BIO) Active Control 1 Intervention

Participants will receive biofeedback intervention during five (5) required weekly 1-hour sessions. A 6th treatment session will be made available for participants if it is shown through anorectal manometry that they are having trouble understanding directions given during the first five sessions.

Group II: Injection (INJ) Active Control 1 Intervention

Bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

RTI International

Collaborator

Trials

201

Recruited

942,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Colon and Rectal Surgery Associates, Ltd.

Collaborator

Trials

3

Recruited

500+

Augusta University

Collaborator

Trials

219

Recruited

85,900+

Published Research Related to This Trial

In a study of 75 participants with fecal incontinence, supplementary home-based biofeedback using a Peritron perineometer significantly improved quality of life, particularly in younger individuals, compared to standard biofeedback alone.

While overall clinical improvements were limited, younger participants showed notable enhancements in continence and quality of life, indicating that home biofeedback can be a beneficial self-management tool for this demographic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. Bartlett, L., Sloots, K., Nowak, M., et al.[2015]

Biofeedback treatment for urinary incontinence is a low-risk and effective management option for certain patients, highlighting its therapeutic potential.

The described biofeedback technique uses external anal sphincter electromyography to provide clear visual and audio feedback, making it adaptable to individual patient needs and easily understandable for those with voiding dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback therapy technique for treatment of urinary incontinence. O'Donnell, PD., Doyle, R.[2019]

Home biofeedback therapy (HBT) for fecal incontinence (FI) is as effective as office biofeedback therapy (OBT), showing significant reductions in weekly FI episodes after 6 weeks of treatment.

HBT not only improved FI symptoms but also enhanced quality of life and anal sphincter pressures, making it a safe and accessible alternative to traditional office-based therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence. Xiang, X., Sharma, A., Patcharatrakul, T., et al.[2022]

Biofeedback therapy has become an effective treatment option for constipation and fecal incontinence, utilizing operant conditioning techniques to help patients regain control over their bowel functions.

The success of biofeedback therapy relies heavily on the motivation of both patients and instructors, leading to significant improvements in patients' quality of life and sustained benefits over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Biofeedback therapy for constipation and fecal incontinence]. Ciochină, AD., Drug, VL.[2011]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Supplementary home biofeedback improves quality of life in younger patients with fecal incontinence. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

Biofeedback therapy technique for treatment of urinary incontinence. [2019]

3. Argentina pubmed.ncbi.nlm.nih.gov

[Biofeedback: a simple and efficient method in the treatment of fecal incontinence]. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of home biofeedback therapy versus office biofeedback therapy for fecal incontinence. [2022]

5. Romania pubmed.ncbi.nlm.nih.gov

[Biofeedback therapy for constipation and fecal incontinence]. [2011]

6. United States pubmed.ncbi.nlm.nih.gov

Biofeedback in the management of partial anal incontinence. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Sphincter training or anal injections of dextranomer for treatment of anal incontinence: a randomized trial. [2016]