Trial to Evaluate Fecobionics in Healthy Subjects and Patients

Study Overview
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Brief Summary
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Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as much as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal. The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. It exceeds previous attempts to make artificial stool for evaluation of defecation and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only.

Detailed Description
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Fecal continence is maintained by several mechanisms including anatomical factors, anorectal sensation, rectal compliance, stool consistency, anal muscle strength, mobility, and psychological factors. The homeostatic balance is easily disturbed by functional or structural anorectal disturbances that may coexist. Common anorectal disorders are fecal incontinence, functional anorectal pain, and functional defecation disorders. These conditions greatly affect life quality for the patients. Current technologies for anorectal functional assessment studies have limitations and often overlap is found between patient groups with lack of correlation between measurements and symptoms. Defecation physiology has been studied for many years but the mechanics and mechanosensation of defecation are still not well understood. Fecobionics combines several existing tests to provide novel insight into anorectal function. The purpose for the development of Fecobionics was to overcome the technological controversies and disagreement between various tests and unphysiological test conditions. The aim was to imitate defecation as close as possible to the natural process. Fecobionics was developed to simulate stool and to provide the driving pressure and resulting deformations of stool along with a measure of an objective anorectal angle during defecation in a single examination. Fecobionics makes it possible to describe objectively, without disturbing the defecation process, the opening characteristics and pressure signatures during initial entry into the relaxing anal canal as well as other parameters The overall goal is to provide mechanistic understanding of defecation in health and defecatory disorders. Fecobionics exceeds previous attempts to make artificial stool for evaluation of defecation and integrates other technologies as well. It was designed to have a consistency and deformability of Type 4 (range type 3-5) on the Bristol stool form scale. The range from types 3-5 is found in 70% of healthy subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction. It is anticipated that Fecobionics will shed light on the neurophysiology of defecation in health and disease, including understanding the effect of biofeedback and neuromodulatory effect of SNS. It will be of great value to provide endpoints in normal subjects that in future studies can be objective measures for monitoring treatment efficacy. The present protocol is on normal subjects only, i.e. studying mechanisms of defecation.

Official Title
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Neurophysiological Mechanism in Sacral Neuromodulation in Patients Suffering From Fecal Incontinence

Conditions
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Normal Subjects, Fecal Incontinence

Intervention / Treatment
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* Device: Fecobionics


Participation Criteria
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Eligibility Criteria
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For Normal Subjects (in California Medical Innovations Institute): Inclusion Criteria: Subject must provide written informed consent; Age 18 years and of age of legal consent; Normal defecation pattern; Within normal range for fecal incontinence severity index (FISI) and Wexner Constipation Scoring System (CSS) scores. Exclusion Criteria: Female, who is pregnant or lactating; Prior abdominal surgery; Diagnosis of fecal incontinence, constipation or anorectal pain. For Patients with Fecal Incontinence (in University of California, San Diego): Inclusion Criteria: Subject must provide written informed consent; Age 18 years and of age of legal consent; Diagnosed Fecal Incontinence and scheduled for sacral neuromodulation treatment Exclusion Criteria: Female, who is pregnant or lactating; Prior abdominal surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 studies<br>Single-arm study | Device: Fecobionics<br>* Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration-based device expulsion parameters | Expulsion Duration - The time it takes to defecate Fecobionics | 1 year | 
| Pressure-based device expulsion parameters | Pressure difference between front and rear of Fecobionics device - A measure of anal sphincter relaxation and key to the determination of defecation phases. Pressure profiles | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical-based expulsion parameters Endpoints | Mechanical Tension of Fecobionics Device (Pressure multiplied with radius). | 1 year | 
| Device orientation and bending-based expulsion parameters | orientation of the device (degrees) and bending angle (degrees, a proxy of the anorectal angle during defecation) | 1 year | 
| Shape-based expulsion parameters | bag shape during defecation. Topographic characteristics of Fecobionics. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anorectal, Fecobionics, defecation, bionics