High definition pressure mapping and electromyography for female pelvic floor guided therapy



 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 15% to 38% of women. The OAB prevalence estimates vary considerably among studies, ranging from 3% to 43%. 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 5 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 α-prototype, bench verification and clinical assessment of its imaging performance needed for the therapy guidance.