Feasibility of Triggered Sacral Neuromodulation for Neurogenic Bladder

Technology
General health
Online since 3 February 2022, updated 837 days ago

About this trial

This trial is enrolling individuals with chronic spinal cord injuries and bladder dysfunction, to test the feasibility of a technique that electrically stimulates nerves in the lower spinal cord (sacral nerves). Researchers want to see if this stimulation affects bladder function (bladder capacity, filling pressure, and contractions). If included, participants will have a small wireless sensor (UroMonitor) temporarily inserted into their bladder to measure bladder pressure and this pressure data will be transmitted to an external radio. A skin-surface electrical stimulator will then automatically turn on sacral nerve stimulation based on the pressure information from the UroMonitor. The stimulation will either be applied for: 1) up to eight hours at three timepoints over a two-week period; or 2) in a continuous fashion for two weeks. Final testing will be performed after 2 weeks.

Included participants

Gender
All
Age
≥ 18 years
Injury level
Level not specified
Time since injury
≥ 6 months
Healthy volunteers
No
Level not specified
Additionally, participants must
have a diagnosis of urinary tract dysfunction
tolerate lying prone for at least 1 hour
NOT have a history of sacral neuromodulation or current sacral neuromodulation leads or implants

What’s involved

Type

Technology

Details

- a small wireless sensor (UroMonitor) will be temporarily inserted into the participant's bladder to measure bladder pressure, which will be transmitted to an external radio - a skin-surface electrical stimulator (ASCU) will automatically determine when to turn on sacral nerve stimulation based on the pressure information from the UroMonitor - the stimulation will either be applied for 1) up to eight hours at three timepoints over a two-week period or 2) in a continuous fashion for two weeks - final testing will be performed after 2 weeks.

Potential benefits

Main benefits

General health

Additional benefits

Bladder health/function

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
  • 3 Oct 2022
  • Organisation
  • VA Office of Research and Development
  • Trial recruitment status
  • Recruiting
  • Trial start date
  • 3 Oct 2022
  • Organisation
  • VA Office of Research and Development

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