High Frequency SARS for Neurogenic Bladder and Bowel Emptying

Completed · Early Phase 1

Conditions studied: Spinal Cord Injury

In brief

The purpose of this study is to determine if bladder emptying can be achieved using stimulation of the sacral roots at certain frequencies. Neurogenic bladder dysfunction occurs after spinal cord injury (SCI). It is a problem that often includes detrusor-sphincter-dyssynergia (DSD), which results in difficulty emptying the bladder due to reflex urethral sphincter contractions during bladder emptying. Individuals with DSD typically require a catheter to empty their bladder. Some people have received an implanted device that stimulates the spinal nerves that connect to the bladder to empty the bladder without a catheter. However, this procedure usually also includes cutting nerves to stop unwanted reflexes. For this study, the investigators are testing a new stimulation pattern to determine if it can help achieve bladder emptying without having to cut nerves. Individuals with SCI who have received an implanted sacral root stimulation device are being asked to participate in this research to test the effectiveness of electrical stimulation to relax the urethral sphincter and promote bladder emptying.

Key facts

Study ID

NCT05214378

Run by

VA Office of Research and Development

People needed

4

Starts

2022-07-01

Expected to finish

2024-07-31

Last updated by the study team

2025-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Uses a SARS System for bladder management
• Suprasacral SCI
• Neurologically stable
• Skeletally mature

You may not qualify if…

• Active sepsis
• Open pressure sores on or around pelvis
• Bleeding diathesis
• Significant urethral trauma, erosion, or stricture

Where it is running

• Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.