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

Technology
Bowel health
Online since 27 June 2023, updated 238 days ago

About this trial

Bowel function following SCI is a high priority for individuals living with SCI. This trial is enrolling individuals with chronic spinal cord injury at the cervical or thoracic level to test the effect of genital nerve stimulation (GNS) on the activity of the anus and rectum, to assess bowel function. If selected, participants will receive GNS applied briefly to determine if they qualify for the study. If qualified, participants will then receive: 1) active electrical stimulation applied to the genital nerve with surface electrodes; and 2) sham stimulation in a random order. Participants will also undergo ano-rectal manometry (ARM) to test anal and rectal function in response to the stimulation.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T12
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T12
    Additionally, participants must
    NOT have cardiac pacemaker other implanted FES device

    What’s involved

    Type

    Technology

    Details

    - One or two study visits (for a total of about 7.5 hours) - In visit 1, participants will receive GNS applied briefly to determine if they qualify for the study. - In visit 2, participants will receive 1) active electrical stimulation applied to the genital nerve with surface electrodes and 2) sham stimulation in a random order. - Ano-rectal manometry (ARM) to test how the anus and rectum are functioning in response to the stimulation

    Potential benefits

    Main benefits

    Bowel health

    Additional benefits

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 21 Mar 2023
    • Organisation
    • MetroHealth Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 21 Mar 2023
    • Organisation
    • MetroHealth Medical Center

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more