Trial to Evaluate Fecobionics in Healthy Subjects and Patients
Condition: Normal Subjects; Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Fecobionics
Intervention type(s): Device
Intervention description(s): Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: anorectal; Fecobionics; defecation; bionics