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

AIM 1: To determine the effect of sacral neuromodulation on urodynamic parameters following
acute spinal cord injury. The following outcomes will be evaluated by urodynamic assessment
at one year post-SCI: (1) maximum cystometric capacity, (2) bladder compliance, (3) presence
of detrusor overactivity, and (4) volume and pressure for first detrusor contraction.

AIM 2: To assess the impact of sacral neuromodulation on patient-reported quality of life
after acute spinal cord injury. Patient-reported QoL will be assessed using the SCI-QOL
bladder question bank and bladder/voiding diaries. Mean SCI-QOL score, daily number of
catheterizations, average catheterization volume, and episodes of incontinence per day will
be compared between groups at one year post-SCI.

AIM 3: To examine the impact of sacral neuromodulation on quantifiable clinical outcomes.
Patients will be followed longitudinally during the study period and assessed for the
following: (1) need for anti-cholinergic medications and/or onabotulinum toxin A treatment,
(2) number of symptomatic UTIs per year, (3) complications attributable to the device, (4)
need for revision of device or leads due to lead migration or failure, (5) development of
hydronephrosis.

Inclusion Criteria:

- Age > 18 years

- Ability to implant device less than 12 weeks post-SCI

- Presence of acute SCI at or above T12

- ASIA Scale A or B

- Expectation to perform 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