We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03083366
Previous Study | Return to List | Next Study

Sacral Nerve Stimulation in Improving Bladder Function 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.
 
ClinicalTrials.gov Identifier: NCT03083366
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : November 11, 2021
Sponsor:
Collaborators:
University of Michigan
Wake Forest University Health Sciences
Rancho Research Institute, Inc.
Information provided by (Responsible Party):
Jeremy Myers, University of Utah

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to see what effects sacral neuromodulation has on bladder function and quality of life in patients with acute spinal cord injury. Within 12-weeks of injury, participants will either receive an implanted nerve stimulator (like a pace-maker for the bladder) or standard care for neurogenic bladder. Patients will be assigned to one of these groups at random and followed for one year. The hypothesis is that early stimulation of the nerves will help prevent the development of neurogenic bladder.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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: Prevention
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 : August 7, 2019
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT03083366


Contacts
Layout table for location contacts
Contact: Karena McDonald, RN 801-213-2780 Karena.McDonald@hsc.utah.edu
Contact: Elizabeth Lignell, BA 801-213-2780 Elizabeth.Lignell@hsc.utah.edu

Locations
Layout table for location information
United States, California
Rancho Los Amigos National Rehabilitation Center Recruiting
Downey, California, United States, 90242
Contact: Sandra Avina-Arrizon, MSPM    562-385-7048    SAvina@ranchoresearch.org   
Principal Investigator: David Ginsberg, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Diana Covalschi, MS    734-763-7144    dcovalsc@med.umich.edu   
Principal Investigator: John Stoffel, MD         
United States, North Carolina
Carolinas Rehabilitation Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Robbin Clark, BSN    704-355-7466    Robbin.Clark@atriumhealth.org   
Principal Investigator: Michael Kennelly, MD         
United States, Utah
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Karena McDonald, BA    801-213-2780    Karena.McDonald@hsc.utah.edu   
Contact: Elizabeth Lignell, BA    801-213-2780    Elizabeth.Lignell@hsc.utah.edu   
Principal Investigator: Jeremy B Myers, MD, FACS         
Sub-Investigator: Sara Lenherr, MD, MSc         
Sponsors and Collaborators
University of Utah
University of Michigan
Wake Forest University Health Sciences
Rancho Research Institute, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Jeremy B Myers, MD University of Utah
  Study Documents (Full-Text)

Documents provided by Jeremy Myers, University of Utah:
Study Protocol and Statistical Analysis Plan  [PDF] December 21, 2018
Informed Consent Form  [PDF] July 17, 2018

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Jeremy Myers, Associate Professor of Surgery, University of Utah
ClinicalTrials.gov Identifier: NCT03083366    
Other Study ID Numbers: 96153
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Neurogenic
bladder
electrical stimulation
neuromodulation
Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Tract Infections
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
 Nervous System Diseases
Trauma, Nervous System
Infections
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases