Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury
- Conditions
- IncontinenceSpinal Cord Injury, AcuteUrinary Tract InfectionsNeurogenic Bladder
- 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
- 5
- Age > 18 years
- Ability to implant device less than 12 weeks post-spinal cord injury (SCI)
- Presence of acute SCI at or above T12
- American Spinal Injury Association (ASIA) Scale A or B
- Expectation to perform clean intermittent catheterization (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
- Primary Outcome Measures
Name Time Method Maximum Cystometric Capacity 12 months Maximum bladder capacity as measured by urodynamic study at 12 months
Quality of Life Differences Measured by Mean SCI-QoL 12 months Participant-reported quality of life as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) bladder question banks at 12 months. Scores range from 64-320 with a lower score indicating greater satisfaction with quality of life.
Number of Urinary Tract Infections Requiring Antibiotics from enrollment through the end of follow-up at 12 months
- Secondary Outcome Measures
Name Time Method Maximum Cystometric Capacity at 3 Months 3 months Maximum bladder capacity as measured by urodynamic study at 3 months
Bladder Compliance 3, 12 months Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.
Presence of Detrusor Overactivity 3, 12 months Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.
Volume at First Detrusor Contraction 3, 12 months Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.
Pressure at First Detrusor Contraction 3, 12 months Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.
Daily Number of Catheterizations 3, 6, 9, 12 months Daily number of catheterizations as reported in the participant diary.
Average Catheterization Volume 3, 6, 9, 12 months Average catheterization volume as determined by participant diary.
Urinary Incontinence Episodes Per Day 3, 6, 9, 12 months Urinary incontinence episodes per day as determined by participant diary.
24 Hour Pad Weight Test 3, 6, 9, 12 months 24 hour pad weight as determined by participant diary.
Development of Hydronephrosis 12 months Development of hydronephrosis during the study period as determined by ultrasound at 12 months.
Need for Anticholinergic Medication from enrollment through the end of follow-up at 12 months Need for Onabotulinum Toxin A Injection from enrollment through the end of follow-up at 12 months Need for Device Revision from implant through the end of follow-up at 12 months Device Explanation from implant through the end of follow-up at 12 months Hospitalizations from enrollment through the end of follow-up at 12 months Urologic Related Surgeries from enrollment through the end of follow-up at 12 months Death from enrollment through the end of follow-up at 12 months
Related Research Topics
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Trial Locations
- Locations (2)
Rancho Los Amigos National Rehabilitation Center
🇺🇸Downey, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Rancho Los Amigos National Rehabilitation Center🇺🇸Downey, California, United States