Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
NCT ID: NCT03083366
Last Updated: 2025-06-10
Study Results
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View full resultsBasic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2019-08-07
2023-04-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Sacral neuromodulation
Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Standard care
Patients will receive standard neurogenic bladder care.
No interventions assigned to this group
Interventions
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PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to implant device less than 12 weeks post-spinal cord injury (SCI)
* Presence of acute SCI at or above T12
* American Spinal Injury Association (ASIA) Scale A or B
* Expectation to perform clean intermittent catheterization (CIC) personally or have caretaker perform CIC
Exclusion Criteria
* Pre-existing SCI
* Pre-existing progressive neurological disorder
* Autonomic dysreflexia
* Prior sacral back surgery
* Posterior pelvic fracture with distortion of the sacroiliac joint
* Prior urethral sphincter or bladder dysfunction
* Chronic urinary tract infections prior to SCI
* Pregnancy at the time of enrollment
* Presence of coagulation disorder or need for anticoagulation that they cannot be stopped temporarily for procedure
* Any significant co-morbidity or illness that would preclude their participation or increase the risk to them having a surgical procedure
* Active untreated infection
* Traumatic injury to the genitourinary system
* Prior pelvic radiation, bladder cancer or other surgical procedure to the bladder that would effect baseline bladder physiology
18 Years
ALL
No
Sponsors
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Rancho Research Institute, Inc.
OTHER
University of Utah
OTHER
Responsible Party
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Jeremy Myers
Associate Professor of Surgery
Principal Investigators
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Jeremy B Myers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Rancho Los Amigos National Rehabilitation Center
Downey, California, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Redshaw JD, Lenherr SM, Elliott SP, Stoffel JT, Rosenbluth JP, Presson AP, Myers JB; Neurogenic Bladder Research Group (NBRG.org). Protocol for a randomized clinical trial investigating early sacral nerve stimulation as an adjunct to standard neurogenic bladder management following acute spinal cord injury. BMC Urol. 2018 Aug 29;18(1):72. doi: 10.1186/s12894-018-0383-y.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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96153
Identifier Type: -
Identifier Source: org_study_id
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