Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence — Bioanatoner  

Urinary Incontinence Clinical Trial

Official title: Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence: Randomized Study

Status Recruiting

Clinical Trial Summary

Biofeedback therapy is an effective treatment for the management of patients with dyssynergic defecation and constipation, urinary incontinence (UI), and fecal incontinence (FI). It is labor-intensive, costly, requires multiple office or hospital visits, is not easily available to the vast majority of patients in the community, and is not covered by many insurance companies.

The purpose of this study is to

1. Evaluate home biofeedback therapy for patients with either constipation and dyssynergic defecation or urinary leakage or stool leakage by assessing the efficacy and safety of a wireless anorectal biofeedback device, and a cellphone app-based and voice guided home biofeedback training system

2. To compare the efficacy and safety of home biofeedback therapy system with the standard of care, office biofeedback therapy

3. To assess the cost-effectiveness of home biofeedback therapy.

Clinical Trial Description

Biofeedback therapy is an effective treatment for the management of patients with constipation and dyssynergic defecation, urinary incontinence, and fecal incontinence, problems that affect 25% of the population in USA. However, it is labor-intensive, costly, requires multiple office or hospital visits, is not widely available to the vast majority of patients in the community, and is not covered by many insurance companies. It is therefore imperative that a more pragmatic biofeedback treatment program that can be administered at home ought to be developed. Our previous studies have shown that home biofeedback training can be just as useful as office-based training, both for constipation with dyssynergia and fecal incontinence. These studies were however performed with older technology that included placement of anal probes connected to hand-held monitors with a liquid crystal display of flashing lights indicating changes in anal pressures. However, these methods are cumbersome and not user-friendly. Further, there is no commercially available home biofeedback system for dyssynergic defecation.

The advent of newer digital technology using cellphone app-based applications, with real time animations and pictorial displays of anorectal anatomical changes than the traditional liquid crystal display (LCD) lights and computer monitors, if adopted, could immensely improve our ability to provide biofeedback training. Also, the interactive images of the human anatomy that are both dynamic and change in real time during the biofeedback maneuvers can prove to be a significant advance over line tracings showing pressure or electromyogram (EMG) changes that many patients find it difficult to comprehend. These animated real time images could enable the patient to visualize and directly connect with their anal or rectal or pelvic floor muscle dysfunction that is causing their bowel or urinary problem. Also, the use of Bluetooth technology will enable wireless transmission of the pressure changes from inside the body to a cellphone display system, avoiding the hassles of connecting a probe with a hand-held device, to view changes. Further, the ability to provide voice guided instructions using the cellphone application (APP) will provide a structured treatment program on how to perform biofeedback training at home that mirrors the office biofeedback training. A 3 sensor electronic anorectal probe with a balloon will be placed in the rectum for assessment of anal and rectal pressures, and this will communicate wirelessly with the cellphone app. This new home biofeedback system could significantly improve our current method of performing biofeedback training.

Our specific aims are: 1) To test the feasibility, efficacy and safety of a wireless anorectal probe, and a cellphone app-based and Bluetooth interfaced, voice guided home biofeedback training system. 2) To compare the efficacy and safety of home biofeedback therapy with the standard of care office biofeedback therapy for the treatment of patients with dyssynergic constipation, fecal incontinence, and urinary incontinence; 3) To examine and compare the cost-effectiveness of home biofeedback therapy with office biofeedback therapy, in each of the 3 patient cohorts.

Our overall hypothesis is that Home Biofeedback Therapy (HBT) is non-inferior to Office-Biofeedback Therapy (OBT), but is more user friendly, easy to administer, and cost effective for the management of patients with constipation and dyssynergic defecation, fecal incontinence and urinary incontinence. ;

Related Conditions & MeSH terms

• Enuresis
• Fecal Incontinence
• Urinary Incontinence

• NCT number: NCT05771597
• Study type: Interventional
• Source: Augusta University
• Contact: Satish Rao, MD, PhD
• Phone: 706-721-2239
• Email: srao@augusta.edu
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Completion date: December 31, 2026