? ? Project Abstract ? Urinary urge incontinence, also known as overactive bladder, is characterized by a strong desire to urinate followed by involuntary contractions of the bladder resulting in a quick release of urine. Approximately 13 million Americans suffer from urinary urge incontinence. The annual cost of routine care and treatment for urinary urge incontinence in the U.S. is estimated at $16.3 billion. Conventional methods to treat urinary urge incontinence include behavioral, pharmacological, surgical, and neurostimulation treatments. However, current treatments for urge incontinence are often inadequate and poorly tolerated, and most people resort to relying on absorbent undergarments. The previous Phase I study demonstrated the feasibility of treating urinary urge incontinence by electrically stimulating the dorsal genital nerves with a percutaneous system. The objective of this Phase II project is to conduct a pilot clinical trial of electrical stimulation of the dorsal genital nerves to treat urinary urge incontinence using a novel miniature implantable pulse generator system. The primary objectives of this Phase II study are to determine whether our therapy is safe and whether it has an effect on the symptoms of urinary urge incontinence.
The specific aims of this project are to evaluate the effect of dorsal genital nerve stimulation on urinary urge incontinence symptoms in females who are unresponsive to conventional therapy (medications, behavior therapy, etc.) and evaluate the possible placebo effect of dorsal genital nerve stimulation on symptoms of urinary urge incontinence. At the completion of this Phase II project, we will have tested a novel approach to the treatment of urinary urge incontinence using an advanced neurostimulation system. The results of this pilot study will be used to design a larger pivotal study that will be used to support an FDA pre-market approval (PMA) application for commercialization. ? ? Project Narrative ? Urinary urge incontinence is a major clinical problem that affects over 13 million Americans and costs over $16 billion each year in the United States. Bladder dysfunction can become an insurmountable barrier, often preventing an individual from maintaining healthy social interactions and from re-entering the work place, and the present treatment options are inadequate and lead to unwanted side effects. We propose to develop a novel therapy that uses electrical stimulation to treat urge incontinence without the side effects of currently available therapies. ? ? ?
