A Multicenter, Prospective, Non-randomized Study on Pathophysiology, Diagnosis, and Biofeedback Therapy in Fecal Incontinence (FI) Using Fecobionics (NORMAL and ABNORMAL-FI)
The California Medical Innovations Institute, Inc.
Summary
The objective is to determine the length-tension properties of the anal sphincters using Fecobionics in normal subjects and FI patients during anal distension and during simulated evacuation. Fecobionics has the consistency and shape of normal stool and can record pressures, cross-sectional area, orientation and viscoelastic properties of the anorectum and can map the geometric profiles during evacuation, and thereby provides multi-dimensional measurements of pressures, deformability, and topographic changes. 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 (BET and FECOM) 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 normal subjects. A major novelty is that Fecobionics measures pressures in axial direction; i.e., in the flow direction.
Description
Defecatory disorders affect 25% of the population and the incidence is rising. These diseases pose a major health care burden and are poorly recognized and treated. The need for better diagnostics and therapeutics is substantial. Defecatory disorders including constipation and fecal incontinence are associated with diet, aging and a variety of underlying factors and diseases. Current diagnostic tests such as the balloon expulsion test (BET), high-resolution anorectal manometry (HRM), defecography, and dynamic pelvic MRI are indirect surrogates for the act of defecation, and provide incomplete…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Subject must provide written informed consent; 2. Willing and able to undergo required study tests, surveys, and procedures; 3. Age \> 18 years of age. Exclusion Criteria: 1. Female who is pregnant; 2. Prior anorectal surgery; 3. Prior bowel resection; 4. History of chronic constipation; 5. In the opinion of the investigator, the subject is not a suitable candidate for the study.
Interventions
- DeviceFecobionics
Fecobionics is a novel device to be inserted through the anal canal into rectum for studying defecation. Anorectal manometry, balloon expulsion test, and anal ultrasonography will be used as reference.
Locations (2)
- California Medical Innovations InstituteSan Diego, California
- Augusta University Medical CenterAugusta, Georgia