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Trial record 9 of 16 for:    SCI | Spinal Cord Injuries | ( Map: Minnesota, United States )

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

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ClinicalTrials.gov Identifier: NCT03083366
Recruitment Status : Recruiting
First Posted : March 20, 2017
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
University of Michigan
Information provided by (Responsible Party):
Jeremy Myers, University of Utah

Tracking Information
First Submitted Date  ICMJE January 27, 2017
First Posted Date  ICMJE March 20, 2017
Last Update Posted Date May 15, 2019
Actual Study Start Date  ICMJE September 1, 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Urodynamic determined maximum cystometric capacity [ Time Frame: 12 months ]
  • Quality of Life differences measured by mean SCI-QoL [ Time Frame: 3, 6, 9, 12 months ]
  • Number of urinary tract infections per year [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03083366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2017)
  • Urodynamics determined maximum cystometric capacity [ Time Frame: 3 months ]
  • Urodynamics determined bladder compliance [ Time Frame: 3, 12 months ]
  • Presence of detrusor overactivity during urodynamics [ Time Frame: 3, 12 months ]
  • Urodynamics determined volume at first detrusor contraction [ Time Frame: 3, 12 months ]
  • Urodynamics determined detrusor pressure at first detrusor contraction [ Time Frame: 3, 12 months ]
  • Number of daily catheterizations [ Time Frame: 3, 6, 9, 12 months ]
  • Average catheterization volume [ Time Frame: 3, 6, 9, 12 months ]
  • Urinary incontinence episodes per day [ Time Frame: 3, 6, 9, 12 months ]
  • 24 hour pad weight test [ Time Frame: 3, 6, 9, 12 months ]
  • Development of hydronephrosis [ Time Frame: continous, 12 months ]
  • Need for anticholinergic medication [ Time Frame: continous, 12 months ]
  • Need for onabotulinum toxin A injection [ Time Frame: continous, 12 months ]
  • Need for device revision [ Time Frame: continous, 12 months ]
  • Need for device explanation [ Time Frame: continous, 12 months ]
  • Hospitalizations [ Time Frame: continous, 12 months ]
  • Urologic related surgeries [ Time Frame: continous, 12 months ]
  • Death [ Time Frame: continuous, 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury
Official Title  ICMJE The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Spinal Cord Injury, Acute
  • Neurogenic Bladder
  • Incontinence
  • Urinary Tract Infections
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Sacral neuromodulation
    Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
    Intervention: Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
  • No Intervention: Standard care
    Patients will receive standard neurogenic bladder care.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ashlea Wilkes, BA 801-213-2700 Ashlea.Wilkes@hsc.utah.edu
Contact: Elizabeth Lignell, BA 801-213-2700 Elizabeth.Lignell@hsc.utah.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03083366
Other Study ID Numbers  ICMJE 96153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jeremy Myers, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE
  • University of Minnesota - Clinical and Translational Science Institute
  • University of Michigan
Investigators  ICMJE Not Provided
PRS Account University of Utah
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP