Restoration of Bladder and Bowel Function Using Electrical Stimulation and Block after Spinal Cord Injury
Technical Report,29 Sep 2015,28 Sep 2016
Palo Alto Veterans Institute for Research and Education Palo Alto United States
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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 Institutional Review Board and the Human Research Protection Organization. Investigational Device Exemption has been obtained from the Food and Drug Administration. Participant recruitment and screening has continued and six subjects have been enrolled and undergone urodynamic evaluation. Four of these have undergone neuromodulation by electrical stimulation via skin surface electrodes. Implantable Vocare stimulators for Stage 1 of the clinical trial have been obtained from the manufacturer.
- Medicine and Medical Research