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NCT01717456 · ClinicalTrials.gov registry record · NA
Educational-Medical-Behavioral Treatment of Fecal Incontinence
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT01717456: Clinical Trial NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01717456 is a NA study that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 31 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
NCT01717456, a NA study, was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of this study is to determine whether this treatment is effective when delivered by home health care nurses to frail elderly patients.
Primary Outcome
At the end of treatment, the FISI requires the patient to report the frequency of occurrence of 4 types of fecal incontinence (solid, liquid, mucus, and gas incontinence) in the past month. These four responses are multiplied by empirically derived patient weights and the values are added together. Range of scores is 0-61. Higher scores show more severe fecal incontinence.
Interventions
- OTHER Education
- DIETARY_SUPPLEMENT Fiber supplements
- DRUG Laxatives or anti-diarrheals
- BEHAVIORAL Pelvic floor muscle exercises
- BEHAVIORAL Tips on how to prevent fecal incontinence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-03 |
| Phase | NA |
Why NCT01717456 stopped before completion
NCT01717456 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 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 5 interventions - of which Education is the first listed.
NCT01717456 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01717456 about?
NCT01717456 is a clinical study titled "Educational-Medical-Behavioral Treatment of Fecal Incontinence". In previous studies at a university referral center the investigators demonstrated that a multicomponent conservative treatment for fecal incontinence was effective. The treatment combines patient education with medical management of diarrhea and constipation plus behavioral training. The purpose of...
What is the current status of trial NCT01717456?
This trial is currently terminated. It is a NA study. The enrollment target is 31 participants. The study started on 2013-01. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01717456?
The interventions under investigation include: Education (OTHER), Fiber supplements (DIETARY_SUPPLEMENT), Laxatives or anti-diarrheals (DRUG), Pelvic floor muscle exercises (BEHAVIORAL), Tips on how to prevent fecal incontinence (BEHAVIORAL).
Who is sponsoring clinical trial NCT01717456?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01717456's enrollment target sits among peer trials
31 1592nd of 2000 higher than 408 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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