Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
- Conditions
- IncontinenceSpinal Cord Injury, AcuteUrinary Tract InfectionsNeurogenic 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
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sacral neuromodulation PrimeAdvanced 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
Name Time Method Urodynamic determined maximum cystometric capacity 12 months Quality of Life differences measured by mean SCI-QoL 3, 6, 9, 12 months Number of urinary tract infections per year 12 months
- Secondary Outcome Measures
Name Time Method Urodynamics determined volume at first detrusor contraction 3, 12 months Number of daily catheterizations 3, 6, 9, 12 months Urodynamics determined bladder compliance 3, 12 months Presence of detrusor overactivity during urodynamics 3, 12 months Urodynamics determined detrusor pressure at first detrusor contraction 3, 12 months Average catheterization volume 3, 6, 9, 12 months Development of hydronephrosis continous, 12 months Need for onabotulinum toxin A injection continous, 12 months Hospitalizations continous, 12 months Urodynamics determined maximum cystometric capacity 3 months Urinary incontinence episodes per day 3, 6, 9, 12 months 24 hour pad weight test 3, 6, 9, 12 months Need for device revision continous, 12 months Need for device explanation continous, 12 months Urologic related surgeries continous, 12 months Need for anticholinergic medication continous, 12 months Death continuous, 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