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Study on Preliminary Safety and Efficacy of Epidural Electrical Stimulation to Manage Lower Urinary Tract Dysfunction After Spinal Cord Injury

Surgery
Bladder health/function
Online since 21 May 2025, updated 203 days ago
Curated trial

About this trial

This feasibility trial is enrolling 3 participants with sub-acute (>6 months) or chronic spinal cord injury to test the effect of epidural spinal stimulation (eSS) on bladder health. eSS is an invasive technique that uses implanted electrodes placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. If included, participants will undergo surgical implantation of the WaveWriter Alpha™ system to improve bladder function. Final assessment of safety will be performed after 10 months.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T11
  • Severity (AIS)?
    • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T11
    Additionally, participants must
    NOT have or need a suprapubic catheter or bladder indwelling catheter
    NOT have an intrathecal baclofen pump
    NOT have a pacemakers for cardiac conditions

    What’s involved

    Type

    Surgery

    Details

    - Participants will undergo surgical implantation of the WaveWriter Alpha™ system for epidural spinal stimulation (eSS). - eSS is an invasive technique that uses an implanted electrode placed next to the spinal cord to deliver electrical stimulation aimed at modifying spinal cord function. - Final assessment of safety will be performed after 10 months.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    Arm/hand function

    General health

    Sensory function

    Spasticity

    Standing/walking/mobility

    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
    • 10 Mar 2025
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    View on clinicaltrials.gov
    for more details
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 10 Mar 2025
    • Organisation
    • Ecole Polytechnique Fédérale de Lausanne
    View on clinicaltrials.gov
    for more details

    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

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