ADVANCED TACTILE IMAGING INC — Department of Health and Human Services SBIR Phase I: N

Description

DESCRIPTION provided by applicant Urinary incontinence UI and overactive bladder OAB are highly prevalent in women and their prevalence is increased with the age In a representative United States survey UI was reported to affect from to of women The OAB prevalence estimates vary considerably among studies ranging from to These conditions are socially embarrassing causing significant morbidity and quality of life impact The pelvic floor muscles PFM form the floor of the female pelvic basin and help maintaining continence by actively supporting the pelvic organs and closing the pelvic openings with their anterior and cephalad action when contracting In the older population pelvic floor disorders represent the intersection of neuro urinary pathology functional and cognitive impairments and changing biomechanical conditions of tissues The treatment options include surgery sacral neuromodulation with implanted electrodes medications pelvic muscle and bladder training and electrical muscle stimulation To date there is no standardized reproducible tool to accurately assess the PFM function in anatomically specific manner and to apply guided muscle stimulation for UI and OAB therapy There is a need in imaging and quantitative assessment of PFM conditions for the effective management of the disorders We propose to develop a new device entitled Restore IT for real time visualization of PFM strength and EMG activity and targeted muscle simulation at specified locations for guided UI and OAB therapy The proposed approach is based on the Vaginal Tactile Imaging technology we disclosed recently in issued patents and its fusion with electromyographic EMG imaging in one probe to be used for the guided therapy In the Phase I we plan development of a Restore IT prototype bench verification and clinical assessment of its imaging performance needed for the therapy guidance PUBLIC HEALTH RELEVANCE This project targets the development of a new device Restore IT for real time visualization of pelvic floor muscles strength The new technology will be a fusion of the tactile and electromyographic imaging in one probe to be used for the guided therapy of disorders associated with the pelvic floor muscles such as urinary incontinence and overactive bladder