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. ? ? ?

Agency
National Institute of Health (NIH)
Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43NS055393-01
Application #
7108237
Study Section
Special Emphasis Panel (ZRG1-BDCN-K (10))
Program Officer
Kleitman, Naomi
Project Start
2006-07-01
Project End
2008-06-30
Budget Start
2006-07-01
Budget End
2008-06-30
Support Year
1
Fiscal Year
2006
Total Cost
$126,581
Indirect Cost
Name
Ndi Medical, LLC
Department
Type
DUNS #
103621566
City
Cleveland
State
OH
Country
United States
Zip Code
44122
Kennelly, Michael J; Bennett, Maria E; Grill, Warren M et al. (2011) Electrical stimulation of the urethra evokes bladder contractions and emptying in spinal cord injury men: case studies. J Spinal Cord Med 34:315-21
Kennelly, Michael J; Arena, Kimberly C; Shaffer, Nell et al. (2010) Electrical stimulation of the urethra evokes bladder contractions in a woman with spinal cord injury. J Spinal Cord Med 33:261-5