Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID05626816

Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Led by MetroHealth Medical Center · Updated on 2025-12-02

52

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

MetroHealth Medical Center

Lead Sponsor

V

VA of Northeast Ohio Health System

Collaborating Sponsor

AI-Summary

What this Trial Is About

Bowel problems, including fecal incontinence, are common and challenging for people living with spinal cord injury (SCI). This research evaluates the effects of genital nerve stimulation (GNS) using non-invasive electrodes on the function of the anus and rectum in individuals with SCI. The study aims to understand how GNS may influence bowel control by measuring anorectal manometry (ARM) outcomes and collecting detailed medical and bowel function information to predict who might benefit from this approach. Participants will undergo two possible visits. The first visit involves screening, informed consent, and brief GNS to determine nerve responsiveness. Those who respond will be invited for a second visit involving ARM testing with and without GNS using a specific protocol (no stimulation, stimulation, no stimulation repeated). This includes insertion of a catheter and electrode placement to record anorectal reflexes and function. The study randomizes participants to receive either sham or effective stimulation first to balance order effects. During participation, individuals will provide bowel program history, complete surveys about bowel function and quality of life, and undergo neurological and clinical exams. Researchers will measure ARM outcomes such as rectal wall tension, anal sphincter function, and reflex activity up to three weeks after enrollment. Transportation and lodging support are available to reduce barriers. The total time commitment is about 7.5 hours across one or two visits.

CONDITIONS

Brief Title

Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Traumatic spinal cord injury
  • At least 6 months since injury
  • Age 18 years or older
  • Neurological injury level T12 or above with AIS grade A-D
  • Positive response to genital nerve stimulation during screening
  • Able to understand and provide informed consent
Not Eligible

You will not qualify if you...

  • Currently enrolled in another functional electrical stimulation research trial
  • Female who is pregnant or planning pregnancy during the trial
  • Presence of cardiac pacemaker, implanted defibrillator, or other implanted FES device that may interact with genital nerve stimulation
  • Medical complications that could interfere with study participation as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) including informed consent, initial screening exams, and brief genital nerve stimulation to determine nerve response.

Treatment

Duration - 1 day

Participants undergo genital nerve stimulation and anorectal manometry testing to assess bowel function with and without stimulation using the London classification protocol.

1 visit (in-person) for instrumentation and testing procedures including bowel program preparation the night before.

Trial Site Locations

Total: 1 location

1

MetroHealth Medical System Old Brooklyn Campus

Cleveland, Ohio, United States, 44109

Actively Recruiting

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Research Team

M

Mayson Moore

R

Rob Hoey, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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