Electrical Stimulation for Continence After Spinal Cord Injury

This study aims to improve continence and voiding of patients with spinal cord injury using electrical stimulation. The Finetech Vocare Bladder System is an implantable sacral nerve stimulator for improving bladder and bowel function in patients 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 nerve. This study is testing the use of the stimulator for inhibiting bladder contraction by stimulating sensory nerves to improve continence after spinal cord injury, and for blocking sphincter contraction to improve voiding.

NCT Number	NCT02978638
Lead Sponsor	Palo Alto Veterans Institute for Research Collaborators: VA Palo Alto Health Care System, Stanford University, Case Western Reserve University, Santa Clara Valley Medical Center, University of New Mexico
Conditions	Spinal Cord Injury, Neurogenic Bladder, Incontinence
Enrollment	10 participants
Start Date	2014-09
Primary Completion	2025-08-28 (estimated)
Study Completion	2025-09-28 (estimated)
Updated on ClinicalTrials.gov	2025-08-03