Electrical Stimulation for Continence After Spinal Cord Injury

Technology
Bladder health/function
Online since 3 November 2021, updated 896 days ago

About this trial

This trial is recruiting individuals with chronic, complete spinal cord injuries to test a surgically implanted electrical stimulation device to control bladder function. This device (Finetech Vocare Bladder System) was approved by the FDA in 1998 to help with urination and bowel function. The main goal of this study is to see if this device can improve bladder control by electrically stimulating bladder contraction nerves rather than by permanently cutting them (cutting sensory nerves is the usual procedure done with Vocare implants; it has undesirable side effects). Participants’ bladder function will be compared (using bladder diaries) when the device is on and off.

Included participants

Gender
All
Age
≥ 22 years
Injury level
C5 - S5
  • Severity (AIS)?
  • AIS-A
    Time since injury
    ≥ 2 years
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C5-S5
    Additionally, participants must
    NOT have other implanted device, e.g. pacemaker

    What’s involved

    Type

    Technology

    Details

    Surgery to have the device implanted. Check-ups every 3 months. Final visit 12 months after trial begin. If the device is safe and successful after 12 months, the participant will have the option to keep the device inside them with regular clinic visits.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    General 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
    • 1 Sep 2014
    • Organisation
    • Palo Alto Veterans Institute for Research
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Sep 2014
    • Organisation
    • Palo Alto Veterans Institute for Research

    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