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NCT02406859 · ClinicalTrials.gov registry record · NA
Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT02406859: Completed NA study, sponsored by VA Office of Research and Development.
NCT02406859 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02406859, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study Summary
An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged stool retention), difficulty with evacuation (difficultly moving bowels), fecal incontinence (problems retaining stool until it is appropriate to move the bowels). Most of the current medications and treatment options address problems of constipation and difficulty with evacuation, but there are few options for individuals who suffer from incontinency. In this study, the investigators propose to study, in detail, anorectal muscle function in individuals with spinal injury - the investigators will do so using new technology called high resolution manometry - which will present the investigator with a 3 dimensional representation of the pressure profile of the anorectal muscles as the subject attempts different maneuvers. A subgroup with representatives of all levels and completeness of injury and anorectal muscle function will be enrolled to participate in six weeks of biofeedback training to see if their bowel function can be improved. During these six weeks, the subjects will be asked to visit the laboratory twice a week in order to be trained by the research team on how to improve their anorectal strength and function in response to visual cues. After the six weeks, another manometry study will be performed. Subjects will then be sent home and asked to perform a series of home exercises for another 6 weeks, after which they will asked to return for a third and final manometry study.
Primary Outcome
We aim to assess the following baseline motility characteristics: maximum sphincter pressure (resting and squeezing pressure), mean sphincter pressure, residual anal and intrarectal pressure (high pressure zone), and recto-anal pressure differential (difference of intrarectal and residual anal pressures) in persons with chronic spinal cord injury (SCI) and able bodied (AB) subjects.
Interventions
- BEHAVIORAL Bowel Biofeedback
- BEHAVIORAL Anorectal Manometry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-07-01 |
| Est. Completion | 2017-12-29 |
| Phase | NA |
What the finished NCT02406859 record still lists
NCT02406859 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Bowel Biofeedback is the first listed.
NCT02406859 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02406859 about?
NCT02406859 is a clinical study titled "Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI". An injury to the spinal cord results in a number of secondary medical problems, including the inability to voluntarily control the bowels. Depending on the severity and location of the injury, remaining bowel function differs, and can include any combination of the following: constipation (prolonged...
What is the current status of trial NCT02406859?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2013-07-01. Estimated completion is 2017-12-29.
What interventions are being tested in trial NCT02406859?
The interventions under investigation include: Bowel Biofeedback (BEHAVIORAL), Anorectal Manometry (BEHAVIORAL).
Who is sponsoring clinical trial NCT02406859?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02406859's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 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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