Stimulation for Bowel Emptying

Not Applicable

Recruiting

• Conditions: Neurogenic Bowel Dysfunction

• Registration Number: NCT06078176
• 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: 2023-10-05
• Study First Submitted QC: 2023-10-05
• Study First Posted: 2023-10-11
• Study Start: 2024-05-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• 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
• At least 18 years old
• At least 12 months post neurological injury or disease diagnosis

Exclusion Criteria

• Active sepsis
• Open pressure sores on or around pelvis
• Significant colon trauma or colostomy
• Crohn's disease
• Colonic obstruction or gastrointestinal surgery within last 3 months
• Significant history of autonomic dysreflexia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Time required to complete bowel emptying	12 weeks	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.

Trial Locations

Locations (1)

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