Sacral Nerve Stimulation in Improving Bladder Function After Acute Traumatic Spinal Cord Injury

The Effectiveness of Early Sacral Nerve Stimulation in Improving Bladder- Related Complications and Quality of Life After Acute Traumatic Spinal Cord Injury

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.

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