Fecobionics in Biofeedback Therapy in Dyssynergia Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fecobionics to Monitor and Predict Biofeedback Therapy in Dyssynergia Patients

Conditions
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Dyssynergia, Constipation

Intervention / Treatment
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* Device: Fecobionics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must provide written informed consent. Age between 21-75 years. Subjects must fulfill the criteria for obstructed defecation/dyssynergia and enter the BFT at UCSD or Scripps. Exclusion Criteria: Female who is pregnant or lactating. Prior abdominal or anorectal surgery or bowel resection. Diagnosis of fecal incontinence, any anorectal symptoms and drug use that affect anorectal function. Confirmed or suspected COVID-19 infection. Severe cardiovascular disease. Subjects not willing to consent and undergo the specified tests in this study. Other exclusions, that in the opinion of the investigator, the volunteer is not a suitable subject for the study.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fecobionics<br> | Device: Fecobionics<br>* Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry and balloon expulsion test may be used as reference. Anorectal manometry and balloon expulsive test are standard methods for anorectal functional measurement.<br>* Other names: Balloon expulsive test;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expulsion Duration | The time it takes to defecate Fecobionics | 1.5 year | 
| Pressure Difference between front and rear ends of Fecobionics | 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. | 1.5 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fecobionics, Biofeedback therapy, Defecation