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Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03083366
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : May 15, 2019
University of Minnesota
University of Michigan
Information provided by (Responsible Party):
Jeremy Myers, University of Utah

Brief Summary:
In the first 3 months after spinal cord injury, patients will be randomized to receive and implantable sacral neuromodulator that will stimulate bilateral S3 nerve roots. These patients will be compared to those receiving standard neurogenic bladder care. Multiple primary and secondary endpoints will be compared based upon urodynamic parameters, quality of life measurements, and clinical outcomes.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury, Acute Neurogenic Bladder Incontinence Urinary Tract Infections Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN) Not Applicable

Detailed Description:

AIM 1: To determine the effect of sacral neuromodulation on urodynamic parameters following acute spinal cord injury. The following outcomes will be evaluated by urodynamic assessment at one year post-SCI: (1) maximum cystometric capacity, (2) bladder compliance, (3) presence of detrusor overactivity, and (4) volume and pressure for first detrusor contraction.

AIM 2: To assess the impact of sacral neuromodulation on patient-reported quality of life after acute spinal cord injury. Patient-reported QoL will be assessed using the SCI-QOL bladder question bank and bladder/voiding diaries. Mean SCI-QOL score, daily number of catheterizations, average catheterization volume, and episodes of incontinence per day will be compared between groups at one year post-SCI.

AIM 3: To examine the impact of sacral neuromodulation on quantifiable clinical outcomes. Patients will be followed longitudinally during the study period and assessed for the following: (1) need for anti-cholinergic medications and/or onabotulinum toxin A treatment, (2) number of symptomatic UTIs per year, (3) complications attributable to the device, (4) need for revision of device or leads due to lead migration or failure, (5) development of hydronephrosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized non-blinded study of sacral neuromodulation plus standard neurogenic bladder care versus standard neurogenic bladder care in patients with spinal cord injury
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sacral neuromodulation
Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Other Name: Sacral neuromodulation

No Intervention: Standard care
Patients will receive standard neurogenic bladder care.

Primary Outcome Measures :
  1. Urodynamic determined maximum cystometric capacity [ Time Frame: 12 months ]
  2. Quality of Life differences measured by mean SCI-QoL [ Time Frame: 3, 6, 9, 12 months ]
  3. Number of urinary tract infections per year [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Urodynamics determined maximum cystometric capacity [ Time Frame: 3 months ]
  2. Urodynamics determined bladder compliance [ Time Frame: 3, 12 months ]
  3. Presence of detrusor overactivity during urodynamics [ Time Frame: 3, 12 months ]
  4. Urodynamics determined volume at first detrusor contraction [ Time Frame: 3, 12 months ]
  5. Urodynamics determined detrusor pressure at first detrusor contraction [ Time Frame: 3, 12 months ]
  6. Number of daily catheterizations [ Time Frame: 3, 6, 9, 12 months ]
  7. Average catheterization volume [ Time Frame: 3, 6, 9, 12 months ]
  8. Urinary incontinence episodes per day [ Time Frame: 3, 6, 9, 12 months ]
  9. 24 hour pad weight test [ Time Frame: 3, 6, 9, 12 months ]
  10. Development of hydronephrosis [ Time Frame: continous, 12 months ]
  11. Need for anticholinergic medication [ Time Frame: continous, 12 months ]
  12. Need for onabotulinum toxin A injection [ Time Frame: continous, 12 months ]
  13. Need for device revision [ Time Frame: continous, 12 months ]
  14. Need for device explanation [ Time Frame: continous, 12 months ]
  15. Hospitalizations [ Time Frame: continous, 12 months ]
  16. Urologic related surgeries [ Time Frame: continous, 12 months ]
  17. Death [ Time Frame: continuous, 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age > 18 years
  • Ability to implant device less than 12 weeks post-SCI
  • Presence of acute SCI at or above T12
  • ASIA Scale A or B
  • Expectation to perform CIC personally or have caretaker perform CIC

Exclusion Criteria:

  • Inability to perform CIC
  • 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03083366

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Contact: Ashlea Wilkes, BA 801-213-2700
Contact: Elizabeth Lignell, BA 801-213-2700

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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Diana Covalschi, MS    734-763-7144   
Principal Investigator: John Stoffel, MD         
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kelly Ayd, BS    612-703-3111   
Principal Investigator: Sean P Elliott, MD, MS         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Ashlea Wilkes, BA    801-213-2700   
Contact: Elizabeth Lignell, BA    801-213-2700   
Principal Investigator: Jeremy B Myers, MD, FACS         
Sub-Investigator: Sara Lenherr, MD, MSc         
Sponsors and Collaborators
University of Utah
University of Minnesota
University of Michigan
  Study Documents (Full-Text)

Documents provided by Jeremy Myers, University of Utah:
Informed Consent Form  [PDF] July 17, 2018

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jeremy Myers, Associate Professor of Surgery, University of Utah Identifier: NCT03083366    
Other Study ID Numbers: 96153
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Jeremy Myers, University of Utah:
spinal cord injury
electrical stimulation
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Trauma, Nervous System
Urinary Tract Infections
Urinary Bladder, Neurogenic
Central Nervous System Diseases
Nervous System Diseases
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Signs and Symptoms