Individuals with a complete spinal cord injury (AIS grade A) of at least 2 years’ duration with neurological level (ISNCSCI level) below C4 may qualify for enrollment in this study. Additional inclusion criteria include intact bladder reflexes, such as detrusor hyper-reflexia and detrusor-sphincter dyssynergia (DSD: uncoordinated contraction of bladder and external urethral sphincter). Individuals typically require medications (e.g. oxybutynin) and catheters to manage these issues. We will review results from recent urodynamics examinations or conduct new examinations to confirm that an individual has these bladder reflexes and qualifies for the implant.
Exclusion criteria include absence of reflex contractions of the bladder; absence of reflex contractions of the external urethral sphincter; external sphincterotomy, urethral stricture or previous urethral or sphincter or bladder or prostate surgery; history of pelvic fracture; individuals on anticoagulants or with coagulation disorders; immunosuppressed individuals; active or recurrent pressure ulcers, particularly in sacral, ischial or trochanteric areas; active untreated infection; active implanted medical device such as cardiac pacemaker or defibrillator; progressive spinal cord injury; pregnancy; mechanical ventilator dependency; any other significant co-morbidity or illness that would preclude their participation or increase the risk to them of participating in the study; and inability or unwillingness to follow study protocol or give informed consent.
If you or someone you know is interested in this study or for more information, please contact Dennis Bourbeau ([email protected]) or Kimberly Schach ([email protected]).