Incontinence is a significant medical problem effecting over 13 million Americans that is not adequately addressed by current treatment options. The rapid growth in the aging demographic suggests that this market will see significant growth in the near and long terms. Electrical stimulation to treat incontinence has been tested and proven effective in both animal models and humans. However the methods of delivery are problematic and have led to sub-optimal performance and slow adoption of the treatment NDI. Medical has developed a new approach to electrical stimulation for control of urge incontinence that will have greater efficacy and a simpler method of delivery. The long-term goal is to develop and commercialize an innovative, proprietary neural prosthesis to control urinary incontinence by inhibiting the bladder via electrical stimulation of the dorsal genital nerves. The immediate goals of this Phase I project are to determine the feasibility of our approach to inhibit bladder contractions in humans with urge incontinence and to determine the feasibility of a minimally invasive surgical technique for electrode implantation. We will conduct non-invasive acute laboratory investigations and short-term home trials to determine whether electrical stimulation of the dorsal genital nerves is an effective treatment for the symptoms of urge incontinence. Cadaver dissections will be conducted to develop and evaluate the electrode implantation technique. At the conclusion of this Phase I project we will have determined the feasibility of treating urge incontinence by electrical stimulation of the dorsal genital nerves and defined the initial requirements for the implanted electrode. In Phase II we will design and fabricate prototype implanted electrodes and conduct a small-scale clinical trial to test the safety, efficacy, and clinical utility of our approach. If successful, this development will result in a new treatment option for persons with urge incontinence that is expected to have greater clinical efficacy, a simpler surgical installation, and a more reliable candidate screening procedure than presently available devices.
Thesaurus Terms: biomedical equipment development, implant, nervous system prosthesis, urinary bladder epithelium, urinary electronic stimulator, urinary incontinence, urinary tract prosthesis electrode, urinary bladder sphincter disorder clinical research, human subject, medical implant science
