Stimulation for Colonic Motility

Neurogenic Bowel Dysfunction Clinical Trial

Official title:

Afferent Stimulation to Evoke Recto-colonic Reflex for Colonic Motility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02641483
• Other study ID #: B1962-W
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2022
• Source: VA Office of Research and Development
• Contact: n/a
• 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: Completed
• Enrollment: 2
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed neurogenic bowel dysfunction and using digital rectal stimulation

• Neurologically stable

• Skeletally mature

• Suprasacral spinal cord injury, stroke, or multiple sclerosis

• At least 6 months post neurological injury or disease diagnosis

Exclusion Criteria:

• Active sepsis

• Open pressure sores on or around pelvis

• Significant colon trauma or colostomy

• 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. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.

Locations

Country	Name	City	State
United States	Louis Stokes VA Medical Center, Cleveland, OH	Cleveland	Ohio
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	Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control)	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. Typically several bouts of digital rectal stimulation are required to achieve complete bowel emptying. We will compare the number of bouts of digital rectal stimulation (control) with electrical rectal stimulation (treatment) required to achieve complete bowel emptying.	1 month