Electrical Stimulation for Continence After Spinal Cord Injury (NCT02978638)
Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block After Spinal Cord Injury
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Palo Alto Veterans Institute for Research — Palo Alto, California
Age range: 22 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Palo Alto Veterans Institute for Research — Palo Alto, California
- Santa Clara Valley Medical Center — San Jose, California
- University of New Mexico — Albuquerque, New Mexico
- MetroHealth Medical Center — Cleveland, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Spinal Cord Injury
- AIH-induced Walking Recovery After Subacute SCI — Atlanta, Georgia
- C-Brace II Spinal Cord Injury — Chicago, Illinois
- Autonomic Effects of Stimulation in SCI — The Bronx, New York
- Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury — Syracuse, New York
- Implanted Myoelectric Control for Restoration of Hand Function in Spinal Cord Injury — Cleveland, Ohio
Explore by condition: All Spinal Cord Injury clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.