Utility of an Animated Bowel Biofeedback Training Routine to Improve Bowel Function in Individuals With SCI

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.

Conditions

• Spinal Cord Injury
• Constipation
• Fecal Incontinence
• Neurogenic Bowel

Interventions

BEHAVIORAL

Bowel Biofeedback

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.

BEHAVIORAL

Anorectal Manometry

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.

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center

  collaborator FED

• VA Office of Research and Development

  lead FED

Principal Investigators

• Mark A Korsten, MD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-07-01

Primary Completion

2017-06-30

Completion

2017-12-29

Countries

• United States

Study Locations