Clinical Trial: Stimulation for Bowel Emptying

Study Status: NOT_YET_RECRUITING
Recruit Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL

Official Title: Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Brief Summary: 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.

Detailed Summary:
Sponsor: VA Office of Research and Development

Current Primary Outcome: 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.

Original Primary Outcome: 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.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: VA Office of Research and Development

Dates:
Date Received: October 05, 2023
Date Started: January 01, 2024
Date Completion: January 01, 2024
Last Updated: October 17, 2023
Last Verified: October 01, 2023