Peripheral Nerve Stimulation for Bladder Emptying

Period of Performance: 07/01/2006 - 06/30/2008

$127K

Phase 1 SBIR

Recipient Firm

NDI Medical, LLC
Cleveland, OH 44122
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): Over 200,000 Americans with spinal cord injury (SCI), who cannot voluntarily control their lower urinary tract, have health problems and a decreased quality of life. Presently, one product using electrical stimulation applied to the sacral nerve roots to restore bladder emptying (VOCARE, Finetech Medical, UK) is commercially available, but it is not widely accepted among the potential patient population because it involves an invasive surgical procedure and requires permanently severing afferent nerves. The long-term goal of this project is to develop and commercialize a less invasive alternative neurostimulation product that does not require nerve transection. The specific aim of this Phase I proposal is to demonstrate the feasibility of eliciting bladder contractions to expel stored urine by electrical stimulation of urethral afferent pathways in the pudendal nerve (PN) in persons with SCI. The hypothesis is that PN afferent stimulation will activate a spinal reflex enabling bladder emptying with low residual volumes without requiring the transection of afferent nerves. This hypothesis will be tested in humans with SCI by stimulating PN afferents with a minimally invasive catheter-electrode technique and measuring 1) bladder pressure evoked by stimulation and 2) bladder volume before and after stimulation. At the conclusion of this Phase I project, we will have determined the feasibility of emptying the bladder by electrical stimulation of the PN afferents in persons with SCI.