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Early Phase 1 N=4 Treatment

High Frequency SARS for Neurogenic Bladder and Bowel Emptying

Spinal Cord Injury

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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