NCT02641483

Stimulation for Colonic Motility

Completed NA Results posted Last updated 21 September 2023

What this trial tests

NA trial testing Electrical Rectal Stimulation in Neurogenic Bowel Dysfunction in 2 participants. Completed in 31 December 2021.

Timeline

1 January 2019

Primary endpoint
31 December 2021

31 December 2021

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	2
Start date	1 January 2019
Primary completion	31 December 2021
Estimated completion	31 December 2021
Sites	2 locations across United States

Drugs / interventions tested

• Electrical Rectal Stimulation

Conditions studied

• Neurogenic Bowel Dysfunction — all drugs for Neurogenic Bowel Dysfunction →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Neurogenic Bowel Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Compare Changes in Number of Interventions Used to Complete Bowel Routine, Including Electrical Rectal Stimulation (Treatment) Versus Mechanical Rectal Distension (Control) Primary · 1 month

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.

Control

Group	Value	95% CI
Colonic Motility	4	4 – 5

Intervention

Group	Value	95% CI
Colonic Motility	1	1 – 3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.