Early Phase 1
N=4
High Frequency SARS for Neurogenic Bladder and Bowel Emptying
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT05214378 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Urethral Sphincter Pressure — 50 cmH2O
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Finetech-Brindley Sacral Anterior Roots Stimulation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urethral Sphincter Pressure |
50 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Uses a SARS System for bladder management
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
Exclusion Criteria
- Active sepsis
- Open pressure sores on or around pelvis
- Bleeding diathesis
- Significant urethral trauma, erosion, or stricture
Data sourced from ClinicalTrials.gov (NCT05214378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.