SBIR Phase I: Design and validation of a novel skin-contacting electrode to provide pelvic floor toning for treatment of female stress urinary incontinence

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the expedited development of a novel non?]surgical medical device and therapeutic treatment for the approximately 1 in 3 women over the age of 30 who suffer from urinary incontinence, two thirds of whom, in part due to notable deficiencies of available solutions, elect to live without treatment while their symptoms progressively worsen. Urinary incontinence, although a very private concern, has far?]reaching physical, psychological, social, and economic implications. For example, urinary incontinence has been found to reduce health-related quality of life measures on par with depression, incontinence is the number one reason for admittance into nursing homes, and the annual cost to the US healthcare system is estimated at $25 billion. Through design and validation activities this project will demonstrate the functionality of a wearable device that provides discreet, comfortable, easy?]to?]use therapy for female stress urinary incontinence. The technological understanding gained through this work lays the groundwork for subsequent development of a commercially viable, FDA cleared product that will enhance the lives of tens of millions of American women. The proposed project provides a new framework for wearable therapeutics by enabling the patient to treat incontinence via discreet surface electrical stimulation without interruption to daily activity. Current non?]surgical care often involves electrical stimulation via intravaginal probe, a treatment most woman are not willing to adopt or maintain. The goal of this project is to demonstrate the ability of a contiguous array of cutaneous electrodes placed proximate the perineal tissue to deliver sufficient electrical muscle stimulation to promote pelvic floor toning, and further to maintain this efficacy under conditions associated with continuous wear. Building on a successful proof?]of?]concept prototype, multiple candidate designs will be developed, fabricated and validated using benchtop models. Testing will explore challenges with maintaining electrode?]skin contact during patient mobility and effective management of bodily fluids (i.e. leakage). Throughout the project, increasingly complex models will be utilized, concluding with assessment in human cadaveric tissue. The project is expected to identify a preferred candidate electrode design suitable for future evaluation in a human clinical study, FDA clearance and product commercialization.