Fecobionics for Constipation

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

Trial Summary

What is the purpose of this trial?

Constipation affects 12-19% of Americans. Pelvic floor dyssynergia is considered to play an important role in constipation but the underlying mechanisms are not well understood in individual patients. The investigators have developed a novel device named Fecobionics that provide detailed mapping of physiological parameters during defecation. The aim of the study is to use Fecobionics to assess anorectal function in dyssynergia patients and monitor and predict the outcome of the biofeedback therapy.

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 data supports the effectiveness of the treatment Fecobionics, Biofeedback Training, and Pelvic Floor Muscle Training for constipation?

Research shows that biofeedback therapy, which is part of this treatment, is effective for managing constipation and fecal incontinence, with response rates between 70% and 80%. It helps improve muscle coordination and strength in the pelvic area, which can ease constipation. ^{1 2 3 4 5}

Is Fecobionics safe for treating constipation?

Biofeedback therapy, which includes techniques similar to Fecobionics, is generally considered safe for treating constipation and other pelvic floor disorders. Studies have shown it to be effective and safe, with improvements often lasting beyond the treatment period. ^{2 4 5 6 7}

How does the treatment Fecobionics for constipation differ from other treatments?

Fecobionics, which involves biofeedback and pelvic floor muscle training, is unique because it uses visual and verbal feedback to help patients improve muscle coordination and strength in the pelvic area, which is often more effective than laxatives for certain types of constipation. This approach helps patients learn to control their muscles better, leading to improved bowel movements. ^{4 5 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Scripps Clinic

Collaborator

Trials

15

Recruited

28,400+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Biofeedback is effective therapy for fecal incontinence and constipation. [2022]

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

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

3. Germany pubmed.ncbi.nlm.nih.gov

Three-dimensional high-resolution anorectal manometry can predict response to biofeedback therapy in defecation disorders. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of Biofeedback Therapy in Clinical Practice for the Management of Chronic Constipation and Fecal Incontinence. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Outlet obstruction constipation (anismus) managed by biofeedback. [2019]

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

Biofeedback treatment of gastrointestinal disorders. [2019]

7. China pubmed.ncbi.nlm.nih.gov

[Pelvic floor biofeedback therapy in pelvic floor diseases]. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Controlled randomised trial of visual biofeedback versus muscle training without a visual display for intractable constipation. [2019]

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

Biofeedback is superior to laxatives for normal transit constipation due to pelvic floor dyssynergia. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

[Therapy of pediatric anorectal incontinence with special reference to biofeedback training]. [2009]