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

Not Applicable
Terminated
Conditions
Incontinence
Spinal Cord Injury, Acute
Urinary Tract Infections
Neurogenic Bladder
Interventions
Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
Registration Number
NCT03083366
Lead Sponsor
University of Utah
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
4
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
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Sacral neuromodulationPrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)Bilateral sacral neuromodulation will start within 3 months of spinal cord injury, as well as standard neurogenic bladder care.
Primary Outcome Measures
NameTimeMethod
Urodynamic determined maximum cystometric capacity12 months
Quality of Life differences measured by mean SCI-QoL3, 6, 9, 12 months
Number of urinary tract infections per year12 months
Secondary Outcome Measures
NameTimeMethod
Urodynamics determined volume at first detrusor contraction3, 12 months
Number of daily catheterizations3, 6, 9, 12 months
Urodynamics determined bladder compliance3, 12 months
Presence of detrusor overactivity during urodynamics3, 12 months
Urodynamics determined detrusor pressure at first detrusor contraction3, 12 months
Average catheterization volume3, 6, 9, 12 months
Development of hydronephrosiscontinous, 12 months
Need for onabotulinum toxin A injectioncontinous, 12 months
Hospitalizationscontinous, 12 months
Urodynamics determined maximum cystometric capacity3 months
Urinary incontinence episodes per day3, 6, 9, 12 months
24 hour pad weight test3, 6, 9, 12 months
Need for device revisioncontinous, 12 months
Need for device explanationcontinous, 12 months
Urologic related surgeriescontinous, 12 months
Need for anticholinergic medicationcontinous, 12 months
Deathcontinuous, 12 months

Trial Locations

Locations (2)

Rancho Los Amigos National Rehabilitation Center

🇺🇸

Downey, California, United States

University of Utah

🇺🇸

Salt Lake City, Utah, United States

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