Ambulatory Closed-loop Stimulation for Bladder Control
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
Traumatic
What’s involved
Type
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/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
- Ended
- Trial start date
- 1 Mar 2021
- Organisation
- MetroHealth Medical Center
- Trial recruitment status
- Ended
- Trial start date
- 1 Mar 2021
- Organisation
- MetroHealth Medical Center
About this trial
Included participants
What’s involved
Potential benefits
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