Recovery of Bladder and Sexual Function After Human Spinal Cord Injury

Technology
Bladder health
Online since 8 November 2021, updated 883 days ago

About this trial

This is a trial to test the effect of a technique for stimulating the spinal cord with an implanted electrode placed next to the spinal cord (epidural stimulation) on bladder, bowel, and cardiovascular function after spinal cord injury. If included, participants with prior implantation of the spinal cord epidural stimulation device (Medtronic scES array) will undergo epidural stimulation and have assessments including monitoring of blood pressure and heart rate responses to bladder filling, bowel stimulation during anal pressure measurements, and bowel evacuation for 6 months. Eligible participants who have not had prior implantation of the scES device will have the same blood pressure and heart rate response assessments (without epidural stimulation) for 6 months.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 month
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    Participants that will receive epidural stimulation must:
    have a prior implantation of a Medtronic spinal cord epidural stimulation array
    use intermittent catheterization for bladder emptying.

    What’s involved

    Type

    Technology

    Details

    Participants with prior implantation of the scES device will undergo epidural stimulation with assessments including bladder filling, bowel stimulation, blood pressure and heart rate monitoring. Participants without prior implantation of the scES device will undergo the same assessments without stimulation.

    Potential benefits

    Main benefits

    Bladder health

    Additional benefits

    Bowel health

    General health

    Sexual health

    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
    • 4 Jan 2021
    • Organisation
    • University of Louisville
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 4 Jan 2021
    • Organisation
    • University of Louisville

    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