Stimulation for Bowel Emptying

Last updated: May 6, 2025
Sponsor: VA Office of Research and Development
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Gastrointestinal Diseases And Disorders

Fecal Incontinence

Treatment

Electrical Rectal Stimulation

Clinical Study ID

NCT06078176
B4529-R
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 rectalstimulation

  • Neurologically stable

  • At least 18 years old

  • At least 12 months post neurological injury or disease diagnosis

Exclusion

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

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Electrical Rectal Stimulation
Phase:
Study Start date:
May 01, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Syracuse VA Medical Center, Syracuse, NY

    Syracuse, New York 13210-2716
    United States

    Active - Recruiting

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio 44106-1702
    United States

    Site Not Available

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