MedPath

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
NameTimeMethod
Maximum Cystometric Capacity12 months

Maximum bladder capacity as measured by urodynamic study at 12 months

Quality of Life Differences Measured by Mean SCI-QoL12 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 Antibioticsfrom enrollment through the end of follow-up at 12 months
Secondary Outcome Measures
NameTimeMethod
Maximum Cystometric Capacity at 3 Months3 months

Maximum bladder capacity as measured by urodynamic study at 3 months

Bladder Compliance3, 12 months

Bladder compliance as measured by urodynamic study (UDS) at 3 and 12 months.

Presence of Detrusor Overactivity3, 12 months

Presence of detrusor overactivity as evaluated by urodynamic study (UDS) at 3 and 12 months.

Volume at First Detrusor Contraction3, 12 months

Bladder volume at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Pressure at First Detrusor Contraction3, 12 months

Bladder pressure at first detrusor contraction as measured by urodynamic study (UDS) at 3 and 12 months.

Daily Number of Catheterizations3, 6, 9, 12 months

Daily number of catheterizations as reported in the participant diary.

Average Catheterization Volume3, 6, 9, 12 months

Average catheterization volume as determined by participant diary.

Urinary Incontinence Episodes Per Day3, 6, 9, 12 months

Urinary incontinence episodes per day as determined by participant diary.

24 Hour Pad Weight Test3, 6, 9, 12 months

24 hour pad weight as determined by participant diary.

Development of Hydronephrosis12 months

Development of hydronephrosis during the study period as determined by ultrasound at 12 months.

Need for Anticholinergic Medicationfrom enrollment through the end of follow-up at 12 months
Need for Onabotulinum Toxin A Injectionfrom enrollment through the end of follow-up at 12 months
Need for Device Revisionfrom implant through the end of follow-up at 12 months
Device Explanationfrom implant through the end of follow-up at 12 months
Hospitalizationsfrom enrollment through the end of follow-up at 12 months
Urologic Related Surgeriesfrom enrollment through the end of follow-up at 12 months
Deathfrom 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
© Copyright 2025. All Rights Reserved by MedPath