Fecobionics for Bowel Incontinence

Recruiting at 1 trial location

Overseen By Satish Rao, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The California Medical Innovations Institute, Inc.

Disqualifiers: Pregnancy, Anorectal surgery, Bowel resection, Constipation, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

155 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is biofeedback therapy safe for treating bowel incontinence?

Biofeedback therapy, which includes exercises and training to improve bowel control, is generally considered safe for treating bowel incontinence. Studies have shown it can be effective and safe, but more research is needed to establish standard protocols. ^{1 2 3 4 5}

How is the Fecobionics treatment for bowel incontinence different from other treatments?

Fecobionics is unique because it allows patients to perform biofeedback training at home using a device that records and stores anal pressure exercises, reducing the need for hospital visits and improving patient compliance. This home-based approach offers a convenient alternative to traditional biofeedback therapies that require frequent clinical supervision. ^{1 3 4 5 6}

What data supports the effectiveness of the treatment Fecobionics, Biofeedback Training, Pelvic Floor Muscle Training for Bowel Incontinence?

Research shows that biofeedback, a part of this treatment, can improve symptoms in 65-75% of patients with fecal incontinence. Additionally, combining biofeedback with pelvic floor muscle training has been shown to improve outcomes in similar conditions like stress urinary incontinence. ^{1 3 4 7 8}

Who Is on the Research Team?

Hans Gregersen, MD, PhD

Principal Investigator

California Medical Innovations Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject must provide written informed consent

Willing and able to undergo required study tests, surveys, and procedures

I am older than 18 years.

Exclusion Criteria

In the opinion of the investigator, the subject is not a suitable candidate for the study.

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

I have had surgery to remove part of my intestines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fecobionics Evaluation

Participants undergo evaluation using the Fecobionics device to measure pressures, cross-sectional area, orientation, and viscoelastic properties of the anorectum.

6-8 weeks

3 visits (in-person)

Biofeedback Training

Participants receive biofeedback training based on Fecobionics data to improve anorectal function.

8 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fecobionics

Trial Overview 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.

How Is the Trial Designed?

Group I: Fecobionics study Experimental Treatment 1 Intervention

Fecobionics

Fecobionics is already approved in United States, European Union for the following indications:

Approved in United States as Biofeedback Therapy for:

• Constipation
• Fecal Incontinence

Approved in European Union as Biofeedback Therapy for:

• Constipation
• Fecal Incontinence

Who Is Running the Clinical Trial?

The California Medical Innovations Institute, Inc.

Lead Sponsor

Trials

4

Recruited

790+

Augusta University Medical Center

Collaborator

Trials

2

Recruited

1,600+

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 is recommended as a first-line treatment for mild to moderate fecal incontinence, showing symptom elimination in up to 50% of patients and symptom reduction in up to 66%, although the studies reviewed had methodological issues.

Recent findings suggest that the interaction between patients and therapists, along with patient coping strategies, may play a more significant role in improving continence than the specific exercises or physiological feedback provided, highlighting the need for better-designed studies to explore these factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral management of fecal incontinence in adults. Norton, C.[2019]

In a pilot study involving 40 women with stress urinary incontinence, adding biofeedback to pelvic floor muscle training significantly improved muscle function and reduced urinary symptoms compared to a control group.

The biofeedback group showed marked improvements in pelvic floor muscle power, endurance, and fast contractions, along with a reduction in nocturnal urinary frequency and effort urine loss, enhancing overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect the adding of biofeedback to the training of the pelvic floor muscles to treatment of stress urinary incontinence]. Fitz, FF., Resende, AP., Stüpp, L., et al.[2019]

In a study of 24 patients with solid-stool fecal incontinence, 71% showed significant improvement after 3-4 biofeedback sessions, with many maintaining these improvements for up to 12 months.

The success of biofeedback training was more closely linked to improvements in sensory perception rather than muscle strength, indicating that enhancing rectal awareness is crucial for effective treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory retraining is key to biofeedback therapy for formed stool fecal incontinence. Chiarioni, G., Bassotti, G., Stanganini, S., et al.[2009]

A new home-based biofeedback device for fecal incontinence was tested in a pilot study with ten patients, showing significant improvements in anal continence both clinically and through manometric measurements.

This device may enhance patient compliance and reduce the need for hospital visits during treatment, offering a promising alternative to traditional biofeedback therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Controlled Biofeedback Device for the Treatment of Fecal Incontinence: A Pilot Study. Damin, DC., Hommerding, F., Schirmer, D., et al.[2018]

Biofeedback therapy is an effective treatment for defecatory disorders, showing response rates of approximately 70-80% for dyssynergic defecation and 76% for fecal incontinence in randomized controlled trials, indicating its efficacy in improving pelvic floor muscle coordination and rectal sensation.

This therapy is safe and can lead to lasting improvements even after the treatment ends, but further research is needed to establish standardized protocols for its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technique of functional and motility test: how to perform biofeedback for constipation and fecal incontinence. Lee, HJ., Jung, KW., Myung, SJ.[2021]

A pilot study involving 40 patients with fecal incontinence showed that biofeedback training using the ACTICORE1 device is non-inferior to traditional Kegel exercises in improving fecal incontinence severity after 16 weeks.

Both training methods resulted in significant improvements in fecal incontinence, indicating that ACTICORE1 could be a viable digital health alternative for pelvic floor training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of biofeedback pelvic floor training with ACTICORE1 on fecal incontinence A prospective multicentric cohort pilot study. Paasch, C., Bruckert, L., Soeder, S., et al.[2022]

In a study involving 50 children and adolescents with severe fecal incontinence, biofeedback training effectively helped 47 participants achieve voluntary bowel movements.

Out of these, 30 children completely eliminated soiling accidents during follow-up periods of six months to three years, demonstrating the efficacy of this intervention for improving anal sphincter control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback: a new modality in the management of children with fecal soiling. Olness, K., McParland, FA., Piper, J.[2019]

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

Behavioral management of fecal incontinence in adults. [2019]

3. Brazil pubmed.ncbi.nlm.nih.gov

[Effect the adding of biofeedback to the training of the pelvic floor muscles to treatment of stress urinary incontinence]. [2019]

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

Sensory retraining is key to biofeedback therapy for formed stool fecal incontinence. [2009]

5. Germany pubmed.ncbi.nlm.nih.gov

Patient-Controlled Biofeedback Device for the Treatment of Fecal Incontinence: A Pilot Study. [2018]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Technique of functional and motility test: how to perform biofeedback for constipation and fecal incontinence. [2021]

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

The effect of biofeedback pelvic floor training with ACTICORE1 on fecal incontinence A prospective multicentric cohort pilot study. [2022]

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

Biofeedback: a new modality in the management of children with fecal soiling. [2019]