High Frequency SARS for Neurogenic Bladder and Bowel Emptying

NCT05214378 | Completed Early Phase 1 Results FDA Device

• 1 other identifier: B4085-P
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Urethral Sphincter Pressure

  urethral sphincter pressure measured in response to presence of stimulation (treatment) compared to pressure in absence of stimulation

  1 day

Study Arms (1)

Treatment Arm

EXPERIMENTAL

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

Interventions

Finetech-Brindley Sacral Anterior Roots Stimulation System DEVICE

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.

Also known as: Vocare

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Syracuse VA Medical Center, Syracuse, NY

Syracuse, New York, 13210-2716, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dennis Bourbeau
• Organization: Cleveland Department of Veterans Affairs

dennis.bourbeau@va.gov

216-791-3800

Study Officials

• Dennis Bourbeau, PhD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Testing alternative stimulation patter in a set of individuals who are already implanted with device. Study participants will act as their own controls comparing outcomes with and without the intervention.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: January 28, 2022
• Study Start: July 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: July 31, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)