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High Frequency SARS for Neurogenic Bladder and Bowel Emptying

NCT05214378 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

Finetech-Brindley Sacral Anterior Roots Stimulation System

Electrodes implanted on sacral roots connected to implanted induction coil. External controller box administers stimulation via induction through skin to electrodes. Stimulation activates nerves to modulate bladder, bowel, and sexual functions.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Dennis Bourbeau, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2024-06-01
Completion
2024-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05214378 on ClinicalTrials.gov