Fecobionics for Constipation

Recruiting at 1 trial location

Overseen By Hans Gregersen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The California Medical Innovations Institute, Inc.

Must not be taking: Anorectal drugs

Disqualifiers: Pregnancy, Abdominal surgery, Fecal incontinence, COVID-19, Cardiovascular disease, 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: 1

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called Fecobionics to better understand constipation, particularly when caused by pelvic floor dyssynergia, a coordination issue during bowel movements. The researchers aim to determine how this device can map bodily processes during defecation and predict the effectiveness of biofeedback therapy for these patients. Individuals experiencing obstructed defecation or dyssynergia and enrolled in biofeedback therapy may be suitable candidates for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research and potentially enhance treatment outcomes.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using drugs that affect anorectal function, you may be excluded from participating.

What prior data suggests that the Fecobionics device is safe for assessing anorectal function?

Research shows that Fecobionics is designed to study constipation by examining how the muscles around the rectum function during bowel movements. Currently, specific safety information for Fecobionics is unavailable. Since this trial is in the "Not Applicable" phase, it lacks established safety evidence.

Fecobionics is intended to assist with biofeedback therapy. Biofeedback is generally considered safe and has been used effectively for conditions like constipation, with few side effects reported in studies. This suggests that Fecobionics might also be well-tolerated, though this is not confirmed.

Without direct safety data for Fecobionics, staying informed and asking the trial team about potential risks or discomforts is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for constipation, like laxatives and fiber supplements, work by softening stool or stimulating bowel movements. But Fecobionics works differently by using a uniquely designed, swallowable device that mimics the natural movement of the intestines. This innovative approach allows researchers to gain insights into how the digestive system functions in real-time, potentially leading to more effective and personalized treatments. Researchers are excited because this method could provide a more accurate diagnosis and understanding of constipation, leading to targeted therapies that go beyond symptom relief.

What evidence suggests that Fecobionics is effective for constipation?

Research has shown that biofeedback therapy can alleviate symptoms of pelvic floor dyssynergia, a condition that can cause constipation. One study found that 90% of patients with this condition improved after receiving biofeedback treatment. In this trial, participants will use Fecobionics, a new tool that helps researchers understand how the pelvic floor muscles function during bowel movements. This tool aims to predict and track the effectiveness of biofeedback therapy. This method could enhance the understanding of constipation and lead to better treatments. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 21-75 with obstructed defecation/dyssynergia who are undergoing biofeedback therapy at UCSD or Scripps. They must consent to the study's tests. Excluded are those unwilling to consent, with COVID-19, severe heart disease, recent gut surgery, fecal incontinence, or women who are pregnant/breastfeeding.

Inclusion Criteria

I have difficulty with bowel movements and am enrolled in the BFT at UCSD or Scripps.

I am between 21 and 75 years old.

Subject must provide written informed consent.

Exclusion Criteria

I have had surgery in my abdomen or rectum area before.

I have been diagnosed with fecal incontinence and experience symptoms or take medications that affect my anorectal function.

Subjects not willing to consent and undergo the specified tests in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Fecobionics device is used to assess anorectal function before biofeedback therapy

1 week

1 visit (in-person)

Biofeedback Therapy

Participants undergo biofeedback therapy with monitoring using the Fecobionics device

12 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after biofeedback therapy

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Fecobionics

Trial Overview The trial is testing a new device called Fecobionics that maps out what happens during bowel movements in patients with dyssynergia. It aims to understand their anorectal function and predict how well they'll respond to biofeedback therapy.

How Is the Trial Designed?

Group I: Fecobionics Experimental Treatment 1 Intervention

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+

Scripps Clinic

Collaborator

Trials

15

Recruited

28,400+

Published Research Related to This Trial

A randomized controlled trial showed that training to contract abdominal muscles and relax the pelvic floor during defecation significantly improved symptoms of severe constipation in patients, regardless of whether biofeedback was used.

Both groups, one with visible electromyographic (EMG) feedback and one without, demonstrated a decrease in pelvic floor muscle activity during straining, suggesting that personal instruction alone can be an effective outpatient treatment for constipation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controlled randomised trial of visual biofeedback versus muscle training without a visual display for intractable constipation. Koutsomanis, D., Lennard-Jones, JE., Roy, AJ., et al.[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 biofeedback training program significantly reduced inappropriate pelvic floor muscle contractions in 15 subjects with chronic constipation, leading to a 69.9% decrease in the anismus index after an average of 3.1 weeks of treatment.

Patients experienced improved defecation frequency and ease, with lasting benefits observed for up to 6.2 months post-treatment, as shown by changes in anorectal angles during defecation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. Kawimbe, BM., Papachrysostomou, M., Binnie, NR., et al.[2019]

In a study of 109 patients with chronic pelvic floor dyssynergia (PFD), those receiving 5 weekly biofeedback sessions showed a significant improvement in symptoms, with 80% reporting major improvement compared to only 22% in the laxative group after 6 months.

The benefits of biofeedback were sustained for at least 2 years, making it a more effective long-term treatment option for PFD compared to continuous use of polyethylene glycol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. Chiarioni, G., Whitehead, WE., Pezza, V., et al.[2022]

Biofeedback is the preferred treatment for many common types of fecal incontinence and shows promise for treating constipation caused by pelvic floor muscle dysfunction, which affects up to 50% of chronic constipation patients.

Thermal biofeedback is effective as part of a comprehensive behavioral treatment for irritable bowel syndrome, and further research is exploring additional applications of biofeedback in gastrointestinal disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatment of gastrointestinal disorders. Whitehead, WE.[2019]

In a study of 92 patients undergoing biofeedback therapy (BT) for outlet constipation and fecal incontinence, 50.5% responded positively to the treatment, indicating its effectiveness.

Specific types of defecation disorders identified through high-resolution manometry (HRM) were predictive of BT success, with type IV and type II disorders showing significant associations with treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional high-resolution anorectal manometry can predict response to biofeedback therapy in defecation disorders. Andrianjafy, C., Luciano, L., Loundou, A., et al.[2020]

In a study of 130 patients undergoing biofeedback therapy (BFT) for chronic constipation (CC) and fecal incontinence (FI), the overall response rate was 76.2%, indicating that BFT is effective in clinical practice, similar to previous clinical trials.

Patients with fecal incontinence had a higher response rate (79.6%) and symptom improvement (67.3%) compared to those with chronic constipation and dyssynergic defecation, who had a lower response rate of 69.8% and only 45.3% showed symptomatic improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Biofeedback Therapy in Clinical Practice for the Management of Chronic Constipation and Fecal Incontinence. Parker, CH., Henry, S., Liu, LWC.[2023]

Pelvic floor biofeedback therapy is a safe and effective treatment for conditions like chronic constipation, urinary incontinence, fecal incontinence, and pelvic floor pain, particularly for patients without severe pelvic organ prolapse or neurogenic defects.

The therapy's success is enhanced when patients have good mental cognition and adhere to treatment, with training focusing on muscle targeting, coordination, and strength, and its effectiveness evaluated through various symptoms and patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. Ding, S.[2018]

In a case series conducted at a tertiary care center, 92% of patients with fecal incontinence and 80% of patients with constipation experienced significant improvement after undergoing electromyogram-guided biofeedback retraining of the pelvic floor.

Despite the high rates of improvement in symptoms, there were no significant changes in electromyographic values, suggesting that biofeedback may help manage symptoms through mechanisms other than direct changes in pelvic floor muscle activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback is effective therapy for fecal incontinence and constipation. Ko, CY., Tong, J., Lehman, RE., et al.[2022]

In a study involving 108 hospitalized children with constipation and fecal incontinence, a comprehensive treatment approach including nutritional, behavioral, and psychological therapies was implemented, showing effectiveness in managing these conditions.

For severe cases, biofeedback conditioning was introduced to enhance anorectal sensitivity and strengthen sphincter control, allowing patients to visualize muscle activity and improve their muscle efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapy of pediatric anorectal incontinence with special reference to biofeedback training]. Stallinger, H., Wurnig, P.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC341393/

Biofeedback for pelvic floor dysfunction in constipation - PMC One study of patients with pelvic floor dyssynergia reported that 90% of those treated by intra-anal electromyographic biofeedback improved compared with 60% of ...

2. 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 ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S209050681400058X

Efficacy of biofeedback-assisted pelvic floor muscle ... A Significant improvement was detected in 19 females (79.2%) in the intervention group compared to 7 females (31.8%) in the control group.

4. 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 ...

5. 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 ... Biofeedback training for fecal incontinence focuses on improving the ability to voluntarily contract the external anal sphincter and ...

6. 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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016508505022742

Biofeedback Is Superior to Laxatives for Normal Transit ... All biofeedback-treated patients reporting major improvement were able to relax the pelvic floor and defecate a 50-mL balloon at 6 and 12 months. Conclusions: ...

8. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/unique-intensive-curriculum-helps-patients-retrain-pelvic-floor-muscles/mac-20506013

Unique, intensive curriculum helps patients retrain pelvic ... The program's intensive curriculum involves retraining the pelvic floor muscles using biofeedback training and behavior modification.