What side effects are associated with this type of intervention?

Biofeedback, which involves training and strengthening pelvic floor muscles, is generally considered safe but may cause temporary discomfort or soreness in the pelvic region. Injection of Solesta, a bulking agent used to improve anal sphincter function, can lead to side effects such as pain at the injection site, minor bleeding, and in rare cases, infection or allergic reactions. Both treatments aim to reduce the frequency of fecal incontinence episodes, but individual responses and side effects may vary.

What prior FDA approvals exist?

The FDA has approved several treatments for bowel incontinence that align with the methods being studied in the trial. Biofeedback, which involves training and strengthening pelvic floor muscles, is a recognized non-invasive therapy for improving bowel control. Solesta, an injectable bulking agent, has been approved by the FDA to improve anal sphincter function by increasing tissue bulk in the anal canal, thereby reducing incontinence episodes. These treatments aim to enhance the structural and functional integrity of the anal sphincter and pelvic floor muscles, providing patients with better control over bowel movements.

What other types of research exist?

Promising novel alternatives for bowel incontinence treatment in 2024 include sacral nerve stimulation (SNS), which has shown efficacy in patients not responding to other treatments. Additionally, advancements in neuromodulation techniques and regenerative medicine, such as stem cell therapy, are emerging as potential options. These treatments aim to improve bowel control by targeting the underlying neural and muscular mechanisms.

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Biofeedback + Injection for Bowel Incontinence

N/A

Waitlist Available

Led By William Whitehead, PhD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Less than 75% reduction in the number of FI episodes after 4 weeks of conservative treatment

Age 18 years or older

Must not have

History of pelvic radiation within the previous 12 months or presence of active radiation proctitis

Patients with Parkinson's disease, multiple sclerosis, severe diabetic neuropathy documented by electromyography (EMG), and neurodegenerative disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site for those receiving Solesta injections or muscle strain from biofeedback exercises. There could also be risks associated with not responding to treatment leading to continued episodes of incontinence.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have Parkinson's, multiple sclerosis, severe diabetic neuropathy, or a neurodegenerative disorder.

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I have experienced significant pain in my anal area in the last 6 months.

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I have had specific pelvic or anal surgeries or issues with synthetic grafts recently.

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I do not have 4 or more very loose bowel movements per day for 4 or more days a week.

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My imaging tests show a significant separation in my internal anal sphincter.

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I have a spinal cord injury or spina bifida.

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I have not had serious anal or rectal problems in the last 6 months.

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I have an intestinal stoma.

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I have been diagnosed with inflammatory bowel disease.

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I am currently on immunotherapy or chemotherapy.

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I have severe rectal prolapse or advanced hemorrhoids.

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I am willing to stop taking unapproved medications or supplements that affect my stool consistency for the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Participants with Specified Adverse Events at Month 3 Follow-Up

Treatment Costs at Month 3 Follow-Up

Treatment Response Defined as a 75% or Greater Change in Number of Average Weekly FI Episodes at Month 3 Follow-Up Compared to Baseline

Secondary study objectives

Change in Psychological Distress as Assessed Using the 7-item Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

Change in Psychological Distress as Assessed Using the 8-item PROMIS Depression Scale

Change in Psychological Distress as Assessed Using the 8-item PROMIS Self-Efficacy Symptom Management Scale

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Biofeedback (BIO)Active Control1 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 Control1 Intervention

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Biofeedback and the injection of bulking agents like Solesta are common treatments for bowel incontinence. Biofeedback focuses on training and strengthening the pelvic floor muscles, improving muscle control and coordination to reduce incontinence episodes. The injection of bulking agents such as Solesta adds volume to the anal sphincter, enhancing its ability to close more effectively and prevent leakage. These treatments are crucial for bowel incontinence patients as they address the underlying muscle and structural issues, providing non-surgical options to improve their quality of life.

[Biofeedback in faecal incontinence].