Stimulation for Bowel Emptying

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

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.

Study Overview

• Status: Recruiting
• Conditions: Neurogenic Bowel Dysfunction
• Intervention / Treatment: Other: Electrical Rectal Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar Colasante-Garrido, MD; Phone Number: (315) 325-4400; Email: cesar.colasante@va.gov

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13210-2716
      • Recruiting
      • Syracuse VA Medical Center, Syracuse, NY
      • Contact: Cesar Colasante-Garrido, MD; Phone Number: 315-325-4400; Email: cesar.colasante@va.gov
      • Principal Investigator: Cesar Colasante-Garrido, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bowel emptying; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: Cleveland Functional Electrical Stimulation Center
• Investigators: Principal Investigator: Dennis Bourbeau, PhD, Louis Stokes VA Medical Center, Cleveland, OH; Principal Investigator: Cesar Colasante-Garrido, MD, Syracuse VA Medical Center, Syracuse, NY

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Intestinal Diseases; Neurogenic Bowel
• Other Study ID Numbers: B4529-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No