High Frequency SARS for Neurogenic Bladder and Bowel Emptying (SARS600)

August 7, 2025 updated by: VA Office of Research and Development

High Frequency Sacral Root Stimulation to Improve Bladder and Bowel Emptying Following SCI

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Spinal cord injury (SCI) leads to neurogenic bladder dysfunctions, and often includes difficulty with emptying the bladder due to detrusor-sphincter dyssynergia (DSD). Current bladder management strategies include catheterization, pharmaceuticals, and/or surgery, but these interventions insufficiently meet individuals' needs. The neurogenic bladder can be emptied using sacral anterior root stimulation (SARS) with electrodes implanted on the sacral nerves to produce bladder contractions. However, this emptying can be impeded by reflex contractions of the urethral sphincter. The sacral sensory roots are typically transected (rhizotomy) to reduce these reflex contractions, but this rhizotomy also impairs desirable reflexes (e.g. sexual function) and sacral sensation if present. Experiments in animals have shown that sacral root stimulation at 600 Hz can inhibit urethral sphincter activity, which has the potential. This approach could be used in lieu of the rhizotomy to improve bladder emptying efficiency.

Objective: The objective of this study is to test the feasibility and potential effectiveness of 600 Hz sacral root stimulation to limit urethral sphincter activity in individuals with neurogenic bladder dysfunction. The investigators hypothesize that sacral root stimulation at 600 Hz will result in lower urethral sphincter pressures compared to pressures in response to stimulation at the lower frequencies that are typically used for SARS.

Study Design: In this feasibility study, the investigators will enroll 8 participants, male or female, who have SCI and who already use implanted sacral root anterior stimulation to manage their bladder. Participants will act as their own controls. Stimulus waveforms for urethral sphincter inhibition will be tested in the clinical laboratory in a single session. The investigators will not need to conduct new surgeries or implant procedures. The primary outcome measure is urethral sphincter pressure, and additional outcome measures include bladder pressure, rectal pressure, and bladder volume as measured in clinically standard urodynamics examination.

Clinical Impact: This approach could help restore bladder function by reducing urethral sphincter activity that impedes bladder emptying for individuals with SCI. The investigators could improve approaches for promoting bladder emptying by eliminating the need for sacral posterior rhizotomy.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210-2716
        • Syracuse VA Medical Center, Syracuse, NY
    • Ohio
      • Cleveland, Ohio, United States, 44106-1702
        • Louis Stokes VA Medical Center, Cleveland, OH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.
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.
Other Names:
  • Vocare

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urethral Sphincter Pressure
Time Frame: 1 day
urethral sphincter pressure measured in response to presence of stimulation (treatment) compared to pressure in absence of stimulation
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Dennis Bourbeau, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

June 1, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

January 21, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 7, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B4085-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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