Stimulation for Bowel Emptying

Neurogenic Bowel Dysfunction Clinical Trial

Official title:

Electrical Rectal Stimulation to Promote Bowel Emptying After Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06078176
• Other study ID #: B4529-R
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2024
• Source: VA Office of Research and Development
• Contact: Cesar Colasante-Garrido, MD
• Phone: (315) 325-4400
• Email: cesar.colasante[@]va.go
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intestinal Diseases
• Neurogenic Bowel
• Neurogenic Bowel Dysfunction

Intervention

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.

Locations

Country	Name	City	State
United States	Syracuse VA Medical Center, Syracuse, NY	Syracuse	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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