Transcutaneous Spinal Cord Stimulation With Bladder and Pelvic Floor Muscle Training

Rehabilitation
Bladder health/function
Online since 19 April 2023, updated 395 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injuries above the sacral level to test the effect of skin-surface (transcutaneous) spinal cord stimulation (SCS) in combination with pelvic floor muscle training (PFMT) on bladder function. If included, participants will undergo either: 1) 8 weeks of at home PFMT; or 2) 8 weeks of standard care without PFMT. All participants will then undergo one session of SCS. All participants will undergo testing of bladder, bowel, sexual function, pelvic floor function, urodynamics, and quality of life (via questionnaire) before the intervention and again at weeks 8 and 14 of the trial.

Included participants

Gender
All
Age
≥ 16 years
Injury level
C1 - L5
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-L5
    Additionally, participants must
    NOT have a cardiac pacemaker, bladder stimulator, or implanted baclofen pump
    NOT have previous bladder/sphincter surgical intervention
    Have urodynamic examination documentation of neurogenic detrussor overactivity

    What’s involved

    Type

    Rehabilitation

    Details

    - Participants will undergo either 1) 8-weeks of at home PFMT or 2) 8-weeks standard of care without PFMT. - Then all participants will undergo one SCS session. - All participants will undergo testing of bladder, bowel, sexual function, quality of life questionnaires, pelvic floor assessments and urodynamics before the intervention and at weeks 8 and 14 of the trial.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    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
    • 16 Mar 2022
    • Organisation
    • Royal National Orthopaedic Hospital NHS Trust
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 16 Mar 2022
    • Organisation
    • Royal National Orthopaedic Hospital NHS Trust

    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