I-Corps: Development of a digital therapeutic device for high tone pelvic floor disorders

University Of North Carolina At Chapel Hill, Chapel Hill NC

Investigators

Abstract

The broader impact/commercial potential of this I-Corps project is the potential development of a connected wireless device and app to guide users through pelvic floor physical therapy at home. In the United States today, over 33 million women suffer from high-tone pelvic floor dysfunction (HTPFD), a neuromuscular disorder of the pelvic floor characterized by non-relaxing pelvic floor muscles, resulting in voiding and defecatory symptoms, sexual dysfunction, and pelvic pain. Due to limited awareness of the condition and the need for a detailed myofascial pelvic exam for diagnosis, patients are often underdiagnosed and undertreated. Of women with HTPFD, only 5 million (less than 15%) complete first-line pelvic floor physical therapy treatment. Potential barriers to PFPT are well established and include the high cost/copay of treatment, time away from work, and distances traveled to a certified pelvic health physical therapist. The commercial application of the device is in addressing the unmet market need for a potentially effective, guided, self-treatment performed at home that may reduce the number of therapy sessions necessary for women to treat symptoms and improve self-treatment compliance. This I-Corps project is based on the development of a connected, wireless pelvic floor wand for the treatment of high-tone pelvic floor dysfunction (HTPFD). The proposed technology could be an interactive pelvic wand designed to sense its position intra-vaginally and communicate with a smartphone application in real-time. This project pursues a potentially disruptive solution to the current deficit in physical therapy telehealth. It could broaden the opportunity for HTPFD patients to initiate treatment in collaboration with physical therapy or alone. Proprietary spatial calibration technology will be designed to help potentially guide patients through targeted pelvic floor muscles and coaching sessions and real-time feedback will optimize pelvic floor muscle release. Using the proposed technology, patients may be able to track, review and share their progress over time. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.