Stimulation for Bowel Emptying

NCT06078176 | Recruiting

• 1 other identifier: B4529-R
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bowel Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (1)

Bowel emptying

EXPERIMENTAL

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.

Other: Electrical Rectal Stimulation

Interventions

Electrical Rectal Stimulation OTHER

Electrical 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.

Bowel emptying

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Cleveland Functional Electrical Stimulation Center: collaborator

Study Sites (1)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

RECRUITING

Study Officials

• Cesar Colasante-Garrido, MD

  Syracuse VA Medical Center, Syracuse, NY

  PRINCIPAL INVESTIGATOR

• Dennis Bourbeau, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cesar Colasante-Garrido, MD

CONTACT

(315) 325-4400; cesar.colasante@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2023
• First Posted: October 11, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)