Below the Belt: Non-invasive Neuromodulation to Treat Bladder, Bowel, and Sexual Dysfunction Following Spinal Cord Injury

Technology
Bladder health/function
Online since 5 November 2021, updated 925 days ago

About this trial

This trial is recruiting individuals with chronic spinal cord injuries to test the effect of skin surface electrical stimulation (transcutaneous spinal cord stimulation: TSCS) on bladder, bowel, and sexual function, as well as on blood pressure (i.e. autonomic function). Earlier studies showed that spinal cord stimulation with an implanted stimulator promoted recovery in these functions; this trial involves no surgery. Participants will be evaluated over 6 weeks, and then will receive one of two interventions for another 6 weeks: 1) moderate TSCS (2 days/week for 12 intervention sessions); or 2) intensive (5 days/week for 30 intervention sessions). In the 12 weeks after the intervention, there will be another 4 follow-up visits, for a total participation time of 25 weeks.

Included participants

Gender
All
Age
18 - 65 years
Injury level
C1 - T6
  • Severity (AIS)?
  • AIS-A
    AIS-B
    Time since injury
    ≥ 1 year
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-T6
    Additionally, participants must
    be a resident of British Columbia, Canada with active provincial medical services plan.
    have a history of bladder dysfunction and, bowel or sexual dysfunction.

    What’s involved

    Type

    Technology

    Details

    The participant will be screened and evaluated over 6 visits over 6 weeks, and then will receive the intervention over another 6 weeks. The intervention will be either 1) moderate TCSCS (2 days/week for 12 intervention sessions) or 2) intense TCSCS (5 days/week for 30 intervention sessions). In the 12 weeks after finishing the intervention, there will be another 4 follow-up visits. Overall, the total duration of participation is 25 weeks.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    Bowel health

    General health

    Mental health and psychosocial factors

    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
    • 2 May 2022
    • Organisation
    • University of British Columbia
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 2 May 2022
    • Organisation
    • University of British Columbia

    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