About this trial
The investigators are testing the effect of electrical stimulation of the rectum on colonic motility. Most individuals with spinal cord injury develop neurogenic bowel dysfunction, which includes slowed colonic motility, which means that stools take longer than normal to pass through the colon. This slowed movement may result in chronic constipation and difficulty emptying the bowels. Individuals typically (without or without caregiver assistance) insert a gloved finger into the rectum and gently stretch it to improve colonic motility for a brief period to empty the bowels. The investigators hypothesize that electrically stimulating the rectum, instead of mechanically stretching it, will produce the same beneficial effect of improving colonic motility. Therefore, this study will compare the two methods. If electrical stimulation effectively improves colonic motility, then the investigator shall develop the approach as a therapeutic intervention in future studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suprasacral spinal cord injury
Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
Bowel routine requires at least 30 minutes or at least 3 cycles of digital rectal stimulation
Neurologically stable
Disqualifiers
Active sepsis
Open pressure sores on or around pelvis
Significant colon trauma or colostomy
Crohn's disease
Trial design
Single group
Treatments tested in this trial
Electrical Rectal Stimulation
Other interventionElectrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility and facilitate bowel emptying. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.
Treatment groups
Trial outcomes
Primary outcomes
Time required to complete bowel emptying
Two interventions will be tested, including the clinical standard of digital rectal stimulation and a novel approach using electrical stimulation of rectal sensory afferents, to determine the effect on colonic pressure. We will compare the time required for the participant to complete their bowel emptying routine between a control period with digital rectal stimulation and a treatment period with electrical rectal stimulation.
Sponsors and contacts
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VA Office of Research and Development
Lead sponsor
Cleveland Functional Electrical Stimulation Center
Collaborator