Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Not Applicable

Recruiting

• Conditions: Constipation; Dyssynergia
• Interventions: Device: Fecobionics

• Registration Number: NCT05807321
• Lead Sponsor: The California Medical Innovations Institute, Inc.

Brief Summary

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.

Detailed Description

This study aims to monitor and predict biofeedback therapy based on mechanism-based and highly integrated data using a new medical device. This study is specifically for patients with dyssynergia before, during, and after biofeedback therapy. The balloon-like Fecobionics device (10 cm long and 1 cm in diameter) will be inserted into the participant's rectum and will record data before and during the expulsion of the device. The participant will be asked to do different motions like cough, squeeze, or push during the procedure. The novel data obtained in this study may help the investigators to identify the patients who will benefit or not benefit from biofeedback therapy before the therapy is done. This will determine the effectiveness of treatments for anorectal disorders.

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-04-11
• Study Start: 2023-10-03
• Status Verified: 2024-12
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-14
• Primary Completion: 2027-01-01
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Subject must provide written informed consent.
2. Age between 21-75 years.
3. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps.

Exclusion Criteria

1. Female who is pregnant or lactating.
2. Prior abdominal or anorectal surgery or bowel resection.
3. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function.
4. Confirmed or suspected COVID-19 infection.
5. Severe cardiovascular disease.
6. Subjects not willing to consent and undergo the specified tests in this study.
7. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fecobionics	Fecobionics	-

Primary Outcome Measures

Name	Time	Method
Expulsion Duration	1.5 year	The time it takes to defecate Fecobionics
Pressure Difference between front and rear ends of Fecobionics	1.5 year	A measure of anal sphincter pressure, the driving rectal pressure, and the difference between these two pressures. This is the key to the determination of defecation phases.

Secondary Outcome Measures

Name	Time	Method
Mechanical Tension of Fecobionics	1.5 year	To reflect anorectal function, the mechanical tension will be computed. The tension is equal to anorectal radius multiply pressure.
Expulsion Velocity	1.5 year	Measured from the time difference between multiple sensor data
Cross-sectional area	1.5 year	Computed by diameter
Anorectal angle	1.5 year	Anorectal angle is an important parameter for defecation

Trial Locations

Locations (1)

California Medical Innovations Institute; 🇺🇸 San Diego, California, United States