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Electrical Stimulation for Continence After Spinal Cord Injury
Sponsor: Palo Alto Veterans Institute for Research
Summary
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.
Official title: Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2014-09
Completion Date
2025-09-28
Last Updated
2025-08-03
Healthy Volunteers
No
Interventions
Finetech Vocare Bladder System
Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.
Locations (4)
Palo Alto Veterans Institute for Research
Palo Alto, California, United States
Santa Clara Valley Medical Center
San Jose, California, United States
University of New Mexico
Albuquerque, New Mexico, United States
MetroHealth Medical Center
Cleveland, Ohio, United States