Our research team at the MetroHealth Medical Center in Cleveland, OH, led by Dennis Bourbeau, PhD, is currently recruiting 1-5 study participants for a new research study. This study aims to improve urinary continence of individuals with spinal cord injury using electrical stimulation of the sacral spinal roots. This is part of a multi-site clinical trial led by Dr. Graham Creasey and listed on clinicaltrials.gov with reference number NCT02978638.
Electrical stimulation is administered using the Finetech Vocare Bladder System, which is an implantable sacral nerve stimulator for improving bladder and bowel function in individuals with spinal cord injury (SCI). It has been commercially available in Britain and other countries since 1982, and has been used in thousands of patients with SCI to improve bladder, bowel, and sexual function. It received FDA approval in 1998 under Humanitarian Device Exemption H980005 and H980008 for providing urination on demand and to aid in bowel evacuation.
Electrical stimulation to produce bladder contraction and improve bladder voiding after spinal cord injury has usually been combined with cutting of sensory nerves to reduce reflex contraction of the bladder, which improves continence. However, cutting these nerves has undesirable side effects. This study will not cut any sensory nerves. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury.
Using electrical stimulation of the sacral spinal roots to improve urinary continence of individuals with spinal cord injury
Dennis Bourbeau, PhD