Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block after Spinal Cord Injury

Abstract

The purpose of the project is to evaluate the restoration of bladder and bowel function using electrical stimulation and block after spinal cord injury in human subjects. Regulatory compliance has been maintained from the Stanford Institutional Review Board and the Human Research Protection Organization. Investigational Device Exemption has been maintained with the Food and Drug Administration. Nine subjects have been enrolled and undergone urodynamic evaluation, six of these have undergone neuromodulation by electrical stimulation via skin surface electrodes and four responded to this neuromodulation. Two did not wish to proceed with surgical implantation of a bladder stimulator, one is considering implantation and one has undergone implantation. In this subject the implant has been successful in restoring micturition without catheterization and continence without medication or rhizotomy for the first time in 41 years. Two additional sites have been added to the trial and recruitment is continuing.

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Document Details

Document Type
Technical Report
Publication Date
Oct 01, 2019
Accession Number
AD1093994

Entities

People

  • Graham Creasey

Organizations

  • Stanford University

Tags

DTIC Thesaurus Topics

  • Biomedical Engineering
  • Biomedical Research
  • Catheterization
  • Clinical Trials
  • Department Of Defense
  • Electrodes
  • Engineering
  • Engineers
  • Health Care
  • Health Services
  • Implantation
  • Institutional Review Board
  • Spinal Cord
  • Spinal Injuries
  • Surgery
  • Test And Evaluation
  • Urinary Tract Physiological Phenomena

Fields of Study

  • Medicine

Readers

  • Clinical Trial Research.
  • Neuroscience
  • Neurotrauma and Rehabilitation Medicine.

Technology Areas

  • Biotechnology