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

• ClinicalTrials.gov Identifier: NCT05214378
• Recruitment Status: Enrolling by invitation
• First Posted: January 28, 2022
• Last Update Posted: July 20, 2022
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Device: Finetech-Brindley Sacral Anterior Roots Stimulation System	Early Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: High Frequency Sacral Root Stimulation to Improve Bladder and Bowel Emptying Following SCI
• Actual Study Start Date: July 1, 2022
• Estimated Primary Completion Date: May 1, 2024
• Estimated Study Completion Date: June 30, 2024

Arms and Interventions

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 Name: Vocare

Outcome Measures

Primary Outcome Measures :

1. urethral sphincter pressure [ Time Frame: 1 day ]
   expect to observe decrease or absence of urethral sphincter pressure in response to stimulation compared to pressure in absence of stimulation during bladder emptying

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

VA Office of Research and Development

Investigators

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

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT05214378
• Other Study ID Numbers: B4085-P
• First Posted: January 28, 2022
• Last Update Posted: July 20, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

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