The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Utah
- Enrollment
- 5
- Locations
- 4
- Primary Endpoint
- Maximum Cystometric Capacity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
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
Outcomes
Primary Outcomes
Maximum Cystometric Capacity
Time Frame: 12 months
Maximum bladder capacity as measured by urodynamic study at 12 months
Quality of Life Differences Measured by Mean SCI-QoL
Time Frame: 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
Time Frame: from enrollment through the end of follow-up at 12 months
Secondary Outcomes
- Maximum Cystometric Capacity at 3 Months(3 months)
- Bladder Compliance(3, 12 months)
- Presence of Detrusor Overactivity(3, 12 months)
- Pressure at First Detrusor Contraction(3, 12 months)
- Volume at First Detrusor Contraction(3, 12 months)
- Daily Number of Catheterizations(3, 6, 9, 12 months)
- Average Catheterization Volume(3, 6, 9, 12 months)
- Urinary Incontinence Episodes Per Day(3, 6, 9, 12 months)
- 24 Hour Pad Weight Test(3, 6, 9, 12 months)
- Development of Hydronephrosis(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)
Investigators
Jeremy Myers
Associate Professor of Surgery
University of Utah