Table 1.

Study inclusion and exclusion criteria

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

Medically stable to discharge to a rehab setting

Exclusion criteria

Inability to perform CIC or have caregiver perform it

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 connot 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