We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 9 for:    surescan

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03083366
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
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. Read our disclaimer for details.
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
University of Michigan
Information provided by (Responsible Party):
Jeremy Myers, University of Utah
  Purpose
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 Intervention
Spinal Cord Injury, Acute Neurogenic Bladder Incontinence Urinary Tract Infections Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jeremy Myers, University of Utah:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Actual Study Start Date: September 1, 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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.


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


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
University of Minnesota - Clinical and Translational Science Institute
University of Michigan
  More Information

Responsible Party: Jeremy Myers, Associate Professor of Surgery, University of Utah
ClinicalTrials.gov Identifier: NCT03083366     History of Changes
Other Study ID Numbers: 96153
First Submitted: January 27, 2017
First Posted: March 20, 2017
Last Update Posted: March 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeremy Myers, University of Utah:
spinal cord injury
Neurogenic
bladder
electrical stimulation
neuromodulation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Urinary Tract Infections
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Infection
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Signs and Symptoms