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NCT05771597 · ClinicalTrials.gov registry record · NA
Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence
A NA study of Urinary Incontinence and Fecal Incontinence, sponsored by Augusta University.
- Recruiting
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT05771597: Recruiting NA study of Urinary Incontinence and Fecal Incontinence, sponsored by Augusta University.
NCT05771597 is a NA study of Urinary Incontinence and Fecal Incontinence that is actively recruiting participants, run by Augusta University. The registered enrollment target is 72 participants, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05771597, a NA study of Urinary Incontinence and Fecal Incontinence, is actively recruiting participants, sponsored by Augusta University.
- RECRUITING
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Home Biofeedback therapy
- OTHER Office biofeedback therapy
Study Locations (1)
Georgia
- Augusta University - Augusta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2026-12-31 |
| Phase | NA |
What NCT05771597 shows while recruiting
NCT05771597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 261-participant average among 48 other Urinary Incontinence trials with a reported enrollment target (72% lower).
The record links to 3 conditions, with Urinary Incontinence appearing as the primary indexed condition, and to 2 interventions - of which Home Biofeedback therapy is the first listed.
NCT05771597 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05771597 about?
NCT05771597 is a clinical study titled "Home Biofeedback Therapy for Dyssynergic Defecation, Fecal Incontinence and Urinary Incontinence". 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 ...
What is the current status of trial NCT05771597?
This trial is currently recruiting. It is a NA study. The enrollment target is 72 participants. The study started on 2023-03-27. Estimated completion is 2026-12-31.
What conditions does trial NCT05771597 study?
This clinical trial studies the following conditions: Urinary Incontinence, Fecal Incontinence, Dyssynergic Defecation.
What interventions are being tested in trial NCT05771597?
The interventions under investigation include: Home Biofeedback therapy (OTHER), Office biofeedback therapy (OTHER).
Who is sponsoring clinical trial NCT05771597?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05771597 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05771597's enrollment target sits among peer trials
72 28th of 48 higher than 21 of 48 other Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Urinary Incontinence trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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