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Home Biofeedback Therapy for Bowel and Bladder Control

This study is testing a new way to deliver biofeedback therapy at home for people experiencing fecal incontinence (accidental bowel leakage), dyssynergic defecation (difficulty emptying bowels), or urinary incontinence (accidental bladder leakage). Biofeedback helps you learn to control your body's functions. Currently, this therapy often requires many office visits and can be expensive. This study aims to see if using a wireless home biofeedback device with a phone app is as effective and safe as traditional office-based biofeedback. We are looking for 72 adults aged 18 and older who have these conditions. Success will be measured by how often you have complete bowel movements or how many episodes of fecal incontinence you experience over 6 and 12 weeks.

Study design
This is an interventional study planning to enroll 72 participants. It compares home biofeedback therapy to traditional office biofeedback therapy.
What's involved
If you have constipation and dyssynergic defecation, you will attend one training session and then practice home biofeedback exercises at least twice a day for six weeks, or receive weekly office biofeedback over six weeks.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored for 6 weeks (short-term) and 12 weeks (long-term) after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05771597

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

Recruiting
NAAges 18+Interventional
Augusta University
~72 participants
Updated 2023-03-16 on ClinicalTrials.gov
What's tested:Home Biofeedback therapyOffice biofeedback therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation
Measured over 6 weeks (short term)
+5 more outcomes measured

Conditions

Fecal Incontinence
Dyssynergic Defecation
Urinary Incontinence

Explore related trials

ConstipationDyssynergic DefecationFecal IncontinenceUrinary Incontinence

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • Satish Rao, MD, PhD · PRINCIPAL_INVESTIGATOR · Augusta University

Who to contact

Satish Rao, MD, PhD
[email protected]
706-721-2239
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Straining with 25% of bowel movements (BM)
Lumpy or hard stools (Form 1 of 2 on the Bristol Stool Scale) with 25% of BM
Sensation of incomplete evacuation with 25% of BM
Sensation of anorectal obstruction/blockage with 25% of BM
Manual maneuvers to facilitate defecation with 25% of BM
\< 3 Spontaneous bowel movements per week 3. Patients must demonstrate dyssynergic pattern of defecation (Types I-IV), during repeated attempts to defecate, and defined as a paradoxical increase in anal sphincter pressure (anal contraction), or less than 20% relaxation of the resting anal sphincter pressure, or inadequate propulsive forces during anorectal manometry.
Dyssynergic pattern of defecation on anorectal manometry plus one or more of the following criteria:
Inability to expel an artificial stool (50 mL water-filled balloon) within 1 minute.
Prolonged colonic transit time on wireless motility capsule (\>59 hours) or \>5 markers retained on a colonic transit study.
Inability to evacuate or ≥ 50% retention of barium during defecography.

What this trial measures

  • The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation6 weeks (short term)

    A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern

  • The number of complete spontaneous bowel movements (CSBM) per week for patients with dyssynergic defecation12 weeks (long term)

    A responder for dyssynergic defecation group is defined as as a subject who demonstrates both ≥ 1 complete spontaneous bowel movement/week and normalization of dyssynergic pattern

  • the number of fecal incontinence (FI) episodes for the FI group6 weeks (short term)

    A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes

  • the number of fecal incontinence (FI) episodes for the FI group12 weeks (long term)

    A responder for FI is defined as an individual reporting at least 50% reduction in weekly number of FI episodes

  • the number of Urinary Incontinence (UI) episodes for UI group6 weeks (short term)

    A responder for UI is defined as an individual reporting at least 50% reduction in weekly number of UI episodes

  • the number of Urinary Incontinence (UI) episodes for UI group12 weeks (long term)

    A responder for UI is defined as an individual reporting at least 50% reduction in weekly number of UI episodes