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

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

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

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

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