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 function using electrical stimulation and block after spinal cord injury in human subjects. Regulatory compliance has been maintained with the Institutional Review Boards and the Human Research Protection Office and Investigational Device Exemption has been maintained with the Food and Drug Administration. Nine subjects have been enrolled and four responded to neuromodulation by electrical stimulation via skin surface electrodes. 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. Three clinical sites are now open, in California, New Mexico and Ohio; recruitment is continuing and has identified several more potential subjects who will be evaluated this year, COVID permitting.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2023
- Accession Number
- AD1220638
Entities
People
- Graham Creasey