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ACTIVE NOT RECRUITING
NCT02978638
NA

Electrical Stimulation for Continence After Spinal Cord Injury

Sponsor: Palo Alto Veterans Institute for Research

View on ClinicalTrials.gov

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

DEVICE

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