Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI
Completed · Not applicable
Conditions studied: Spinal Cord Injury, Constipation, Fecal Incontinence, Neurogenic Bowel
In brief
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.
Key facts
- Study ID
- NCT02406859
- Run by
- VA Office of Research and Development
- People needed
- 50
- Starts
- 2013-07-01
- Expected to finish
- 2017-12-29
- Last updated by the study team
- 2021-09-17
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic SCI (duration over 1 year)
- Able-bodied (no SCI)
You may not qualify if…
- Contraindication to bowel biofeedback
- Currently pregnant or trying to become pregnant
- Inability to provide informed consent
Where it is running
- James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States
Full record on ClinicalTrials.gov
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