What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include biofeedback, medications like loperamide, and behavioral therapies. Biofeedback, which helps patients improve control over their pelvic floor muscles, generally has no significant side effects. Medications such as loperamide can cause constipation, abdominal pain, and bloating. Behavioral therapies, including dietary changes and pelvic floor exercises, are typically safe but may require time and commitment to see results. Overall, these treatments are well-tolerated, with constipation being the most frequently reported side effect.

What prior FDA approvals exist?

FDA-approved treatments for bowel incontinence have primarily focused on medications and devices that manage symptoms rather than simulating stool for diagnostic purposes. Common treatments include antidiarrheal agents like loperamide, bile acid sequestrants, and various forms of biofeedback therapy. While Fecobionics represents a novel approach by simulating stool to measure anorectal function, there are no prior FDA-approved treatments that use a similar method for diagnosing or treating bowel incontinence.

What other types of research exist?

Promising novel alternatives to Fecobionics for bowel incontinence patients include high-resolution anorectal manometry (HRM) and the artificial sphincter system with biofeedback function. HRM provides detailed pressure profiles and minimizes motion artifacts, while the artificial sphincter system simulates human sphincter function and is in advanced stages of development.

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Behavioural Intervention

Fecobionics for Bowel Incontinence

N/A

Recruiting

Led By Hans Gregersen, MD, PhD

Research Sponsored by The California Medical Innovations Institute, Inc.

Eligibility Criteria Checklist

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

Must have

Age > 18 years of age

Be older than 18 years old

Must not have

Prior anorectal surgery

Prior bowel resection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 year

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a device called Fecobionics, which mimics normal stool, to measure internal pressures and movements in the rectum and anus. It targets patients with fecal incontinence to better understand muscle function during defecation. The goal is to improve diagnosis and treatment by providing detailed insights into how these muscles work. Fecobionics is a simulated stool device developed to replace several current tests of anorectal function and has been used in both animal and human studies to assess defecation patterns.

Who is the study for?

This trial is for individuals aged 18 to 75 who experience bowel incontinence or are healthy volunteers. Participants must be willing and able to complete study procedures and provide consent. It's not suitable for those with chronic constipation, prior bowel resections, anorectal surgery, or pregnant women.

What is being tested?

The trial tests a device called Fecobionics which mimics natural stool to measure the function of the anal sphincters during defecation. It aims to provide a realistic simulation of bowel movements and gather data on pressure, orientation, and viscoelastic properties of the anorectum.

What are the potential side effects?

As Fecobionics is a diagnostic tool rather than medication, traditional side effects like those seen with drugs may not apply. However, discomfort or potential injury from insertion could occur.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

Exclusion Criteria

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

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I have had surgery in the anal or rectal area before.

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I have had surgery to remove part of my intestines.

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I am currently pregnant.

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I have a long-term issue with constipation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Front-rear pressure difference (in cmH2O) will be measured

Secondary study objectives

Anorectal angle (in degree) will be measured

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fecobionics studyExperimental Treatment1 Intervention

Fecobionics

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fecobionics

2021

N/A

~50

0 / 5Eligibility 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

The most common treatments for bowel incontinence include biofeedback therapy and novel technologies like Fecobionics. Biofeedback therapy helps patients learn to control their pelvic floor muscles and improve anorectal function through sensory retraining and muscle relaxation techniques. Fecobionics, a novel device, simulates stool to measure pressures, deformability, and topographic changes in the anorectum, providing detailed insights into defecatory mechanics. Understanding these mechanisms is crucial for bowel incontinence patients as it allows for personalized treatment plans that target specific dysfunctions, thereby improving symptom management and quality of life.

The role of biofeedback in the treatment of gastrointestinal disorders.Theoretical Tools to Analyze Anorectal Mechanophysiological Data Generated by the Fecobionics Device.Novel Bionics Assessment of Anorectal Mechanosensory Physiology.