High Frequency SARS for Neurogenic Bladder and Bowel Emptying (SARS600)
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|ClinicalTrials.gov Identifier: NCT05214378|
Recruitment Status : Enrolling by invitation
First Posted : January 28, 2022
Last Update Posted : July 20, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Device: Finetech-Brindley Sacral Anterior Roots Stimulation System||Early Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|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)|
|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|
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
- 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
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Uses a SARS System for bladder management
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
- Active sepsis
- Open pressure sores on or around pelvis
- Bleeding diathesis
- Significant urethral trauma, erosion, or stricture
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214378
|United States, Ohio|
|Louis Stokes VA Medical Center, Cleveland, OH|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Dennis Bourbeau, PhD||Louis Stokes VA Medical Center, Cleveland, OH|
|Responsible Party:||VA Office of Research and Development|
|Other Study ID Numbers:||
|First Posted:||January 28, 2022 Key Record Dates|
|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|
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries