Stimulation for Colonic Motility

Not Applicable

Completed

• Conditions: Neurogenic Bowel Dysfunction
• Interventions: Other: Electrical Rectal Stimulation

• Registration Number: NCT02641483
• Lead Sponsor: VA Office of Research and Development

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-12-22
• Study First Submitted QC: 2015-12-22
• Study First Posted: 2015-12-29
• Study Start: 2019-01-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2022-11
• Results First Submitted: 2022-11-09
• Results First Submitted QC: 2022-11-09
• Last Update Submitted: 2022-11-09
• Results First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation
• Neurologically stable
• Skeletally mature
• Suprasacral spinal cord injury, stroke, or multiple sclerosis
• At least 6 months post neurological injury or disease diagnosis

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Exclusion Criteria

• Active sepsis
• Open pressure sores on or around pelvis
• Significant colon trauma or colostomy
• History of autonomic dysreflexia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colonic Motility	Electrical Rectal Stimulation	Study participants will act as their own controls, first providing data using their usual digital rectal stimulation intervention for bowel care, then providing data using electrical stimulation for bowel care.

Primary Outcome Measures

Name	Time	Method
Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)	1 month	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. Typically several bouts of digital rectal stimulation are required to achieve complete bowel emptying. We will compare the number of bouts of digital rectal stimulation (control) with electrical rectal stimulation (treatment) required to achieve complete bowel emptying.

Trial Locations

Locations (2)

Syracuse VA Medical Center, Syracuse, NY; 🇺🇸 Syracuse, New York, United States

Louis Stokes VA Medical Center, Cleveland, OH; 🇺🇸 Cleveland, Ohio, United States