An implantable neuroprosthesis for restoring bladder and bowel control to patients with spinal cord injuries: A multicenter trial

Objective: To evaluate the safety and efficacy of an implanted neuroprosthesis for management of the neurogenic bladder and bowel in individuals with spinal cord injury (SCI). Design: Prospective study comparing bladder and bowel control before and at 3, 6, and 12 months after implantation of the neuroprosthesis. Setting: Six US hospitals specializing in treatment of SCI. Patients: Twenty-three neurologically stable patients with complete suprasacral SCIs. Intervention: Implantation of an externally controlled neuroprosthesis for stimulating the sacral nerves and posterior sacral rhizotomy. Main Outcome Measures: Ability to urinate more than 200mL on demand and a resulting postvoid residual volume of less than 50mL. Results: At 1-year follow-up, 18 of 21 patients could urinate more than 200mL with the neuroprosthesis, and 15 of 21 had postvoid volumes less than 50mL (median, 15mL). Urinary tract infection, catheter use, reflex incontinence, anticholinergic drug use, and autonomic dysreflexia were substantially reduced. At 1-year follow-up, 15 of 17 patients reduced the time spent with bowel management. Conclusions: Neural stimulation and posterior rhizotomy is a safe and effective method of bladder and bowel management after suprasacral SCI.