Ambulatory Closed-loop Stimulation for Bladder Control

Technology
Bladder health
Online since 28 August 2023, updated 23 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injuries to test the effect of non-invasive electrical stimulation applied to the genital area to inhibit bladder contractions. Bladder spasms are detected with an automated wireless sensor called UroMonitor, which activates a device to deliver genital nerve stimulation. This stimulation has been shown previously to relax the bladder, allow for increased capacity, and reduce incontinence. If included, participants will undergo: 1) a consent visit; 2) a urodynamic screening visit; and 3) a day-long visit with insertion of UroMonitor into the bladder and application of electrodes to the appropriate areas of the genitals. The system will be tested during the third visit and then removed.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S1
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Healthy volunteers
    No
    C1-S1
    Additionally, participants must
    have bladder spasms (neurogenic detrusor overactivity) confirmed by urodynamic study

    What’s involved

    Type

    Technology

    Details

    - a screening visit during which a urine sample will be taken, - a 4-hour urodynamic screening visit, which includes a catheter bing inserted into the bladder and another in the rectum (up to 6 times, with and without stimulation), and - a 8-hour visit during which the UroMonitor sensor will be insert into the bladder through the urethra to measure pressure and transcutaneous electrical nerve stimulation (TENS) will be applied to the genital nerve via surface electrodes put on the top of the penis (males) or near the clitoris (females). - The UroMonitor sensor will be retrieved via a suture that remains in the urethra. - Final testing will be performed after 2 weeks.

    Potential benefits

    Main benefits

    Bladder health

    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 Mar 2021
    • Organisation
    • MetroHealth Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 1 Mar 2021
    • Organisation
    • MetroHealth Medical Center

    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