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 tests a new tool called Fecobionics, designed to improve understanding of bowel movements, particularly for those with bowel incontinence. Fecobionics mimics a real stool and measures the response of anal muscles during bowel movements. The goal is to gain insights into bodily functions during defecation and enhance testing methods. Individuals who have experienced bowel incontinence and can undergo the required study tests might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance diagnostic methods for bowel incontinence.

Will I have to stop taking my current medications?

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

What prior data suggests that Fecobionics is safe for bowel incontinence studies?

Research shows that Fecobionics is designed to mimic natural stool during tests that evaluate bowel movement function, aiming to make these tests more realistic. Although specific studies on the safety of Fecobionics are lacking, it is intended to make testing more natural and less intrusive.

Fecobionics is not a new drug or chemical treatment; it functions as a tool to measure bowel function. As a result, it may have fewer side effects compared to medication-based treatments. However, since detailed safety data is unavailable, potential risks are still under investigation.

This trial is labeled as "Not Applicable" for phase, indicating that the safety information might not be as comprehensive as in later-phase trials. Participants should consult their healthcare provider to discuss any concerns and better understand the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fecobionics is unique because it offers a new approach to managing bowel incontinence by simulating the natural function of the bowels. Unlike traditional treatments like medications or surgical interventions, Fecobionics uses a biofeedback tool (BFT) that provides real-time feedback on bowel function. This innovative method allows both patients and healthcare providers to better understand and potentially improve bowel control. Researchers are excited because this could lead to more personalized and effective management of bowel incontinence, offering hope for patients seeking alternatives to existing treatment options.

What evidence suggests that Fecobionics is effective for bowel incontinence?

Research has shown that Fecobionics can help treat bowel incontinence by mimicking natural stool and providing detailed information about rectal and anal function. In this trial, participants may receive Fecobionics as part of a biofeedback training (BFT) tool, which studies indicate improves symptoms in 65-75% of individuals with bowel incontinence. This method combines several existing tests to provide a comprehensive view of bodily functions during bowel movements. By measuring pressures and changes in the anal canal, Fecobionics offers new insights that could enhance the management of bowel incontinence. ^{1 6 7 8 9}

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

Group II: Feco BFT Active Control 1 Intervention

In this ARM Fecobionics will be used as a BFT tool

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 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 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]

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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9132520/

Fecobionics Evaluation of Biofeedback Therapy in Patients ... Studies were performed in 12 patients before and after 8 weeks of biofeedback training. The Fecal Incontinence Severity Index (FISI) score was obtained. Anal ...

2. mdpi.com mdpi.com/2624-5647/6/3/53

Effectiveness of Pelvic Floor Muscle Training for Treating ... The effectiveness of pelvic floor muscle training for treating faecal incontinence ranges from 41% to 66%, and there are reports that this rate ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1542356518313910

Efficacy of Supervised Pelvic Floor Muscle Training and ... We found that participants who received supervised PFMT had 5-fold higher odds of reporting improvements in fecal incontinence symptoms and had a larger mean ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7843943/

Biofeedback for Pelvic Floor Disorders - PMC Biofeedback has demonstrated efficacy in the treatment of chronic constipation with dyssynergic defecation, fecal incontinence, and low anterior resection ...

5. withpower.com withpower.com/trial/phase-normal-subjects-5-2022-20f98

Fecobionics 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 ...

6. blueshieldca.com blueshieldca.com/content/dam/bsca/en/provider/docs/2024/February/PRV_Biofeedback_TX_Fecal_Incontinence_Constipation.pdf

2.01.64 Biofeedback as a Treatment of Fecal Incontinence ... The purpose is to strengthen the force of the pelvic floor muscle contraction without including rectal distention. Some training increases ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4398720/

Bio-feedback treatment of fecal incontinence In EMG training, the patient is asked to squeeze and relax without rectal distention, and home exercises in which the patient is required to repeatedly squeeze ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4174224/

Pelvic Floor Rehabilitation in the Treatment of Fecal ... Pelvic floor rehabilitation treatment for FI is thought to be effective and safe, with reported success rates in a majority of studies at 50 to 80%. Many more ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03216291

Home Versus Office Biofeedback Therapy for Fecal ... The purpose of this study is to assess whether having patients train their pelvic floor muscles at home is as effective as in-office biofeedback training.