CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Bowel Biofeedback +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02406859
NCT02406859N/ACompleted

Bowel Biofeedback Training to Improve Bowel Function in Individuals With SCI

VA Office of Research and Development·interventional·Posted Apr 2, 2015·Updated Sep 17, 2021

In Brief

A clinical study evaluating Bowel Biofeedback and Anorectal Manometry for Spinal Cord Injury and 3 related conditions. Completed, enrolled 50 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2, 2015
Enrollment StartJul 1, 2013
Primary CompletionJun 30, 2017
Study CompletionDec 29, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.3 years ago

Interventions

Bowel Biofeedbackbehavioral

Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks.

Anorectal Manometrybehavioral

Subjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training.