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NCT03216291 · ClinicalTrials.gov registry record · NA
Home Versus Office Biofeedback Therapy for Fecal Incontinence
A NA study, sponsored by Augusta University.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
NCT03216291: Completed NA study, sponsored by Augusta University.
NCT03216291 is a NA study that has completed, run by Augusta University. The registered enrollment target is 33 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03216291, a NA study, has completed, sponsored by Augusta University.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
Study Summary
Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with Fecal Incontinence. It is not easily available to the vast majority of patients in the community with this problem. It is therefore imperative that a more pragmatic therapeutic approach that can be administered easily in the community ought to be developed. However, whether a treatment program that is based on home-training can be just as useful as office-based training has not been evaluated. The purpose of this study is to assess whether having patients train their pelvic floor muscles at home is as effective as in-office biofeedback training.
Primary Outcome
Assess the change in the No of FI episodes between baseline week and end of study week and compare between the two treatment groups. Responder is defined as a patient with greater than 50% reduction in FI episodes after treatment when compared to baseline. Responder rates will compared between the two treatment groups.
Interventions
- BEHAVIORAL biofeedback therapy
- DEVICE Home Biofeedback therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2015-10 |
| Est. Completion | 2019-09-30 |
| Phase | NA |
What the finished NCT03216291 record still lists
NCT03216291 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which biofeedback therapy is the first listed.
NCT03216291 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03216291 about?
NCT03216291 is a clinical study titled "Home Versus Office Biofeedback Therapy for Fecal Incontinence". Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with Fecal Incontinence. It is not easily available to the vast majority of patients in the community with this problem. It is therefore imperative that a more pragmatic therapeutic approach th...
What is the current status of trial NCT03216291?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2015-10. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT03216291?
The interventions under investigation include: biofeedback therapy (BEHAVIORAL), Home Biofeedback therapy (DEVICE).
Who is sponsoring clinical trial NCT03216291?
This trial is sponsored by Augusta University, which has 106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03216291's enrollment target sits among peer trials
33 1574th of 2000 higher than 423 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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