Electrical Stimulation for Continence After Spinal Cord Injury

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.

Conditions

• Spinal Cord Injury
• Neurogenic Bladder
• Incontinence

Interventions

DEVICE

Finetech Vocare Bladder System

Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.

Sponsors & Collaborators

• VA Palo Alto Health Care System

  collaborator FED

• Stanford University

  collaborator OTHER

• Case Western Reserve University

  collaborator OTHER

• Santa Clara Valley Medical Center

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• Palo Alto Veterans Institute for Research

  lead OTHER

Principal Investigators

• Graham H. Creasey, MD · Palo Alto Veterans Institute for Research

• Reza Ehsanian, MD PhD · University of New Mexico

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2025-08-28

Completion

2025-09-28

FDA Device

Yes

Countries

• United States

Study Locations