SBIR Phase I: An ambulatory pelvic floor monitoring and feedback device for use in physical therapy

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a novel device that enables pelvic therapists to evaluate, diagnose, and treat patients during activities responsible for pelvic floor symptoms. One in four women in the US has a pelvic floor disorder and this disorder results in $20 billion in annual costs and negative recurring patient experiences. Pelvic physical therapy is the recommended first-line treatment but requires regular management, burdening the patient and clinical resources with each visit. Current systems are limited to static patient conditions with specific situational muscle conditions. This novel pelvic floor monitoring device aims to provide optimized pelvic floor muscle feedback during chronic ambulatory conditions when a significant percent of pelvic floor events occur. This Small Business Innovation Research (SBIR) Phase I project is a novel device to reduce the burden of pelvic floor disorders in a patient self-managed manner. A wearable pelvic floor monitoring device will provide dynamic evaluation and treatment for chronic ambulatory conditions. This project aims to design and prototype the components and system of a pelvic floor force sensor for use during exercise. The device will be integrated into a comfortable and ergonomically fitted silicone shell with interchangeable sleeves to fit different patients’ anatomies, and a wireless biofeedback software for communicating data from the device to the patient and therapist. The system will be benchtop tested to ensure accurate and robust performance of the sensors and data transmission. The ergonomic shape will be tested in a limited patient pilot for comfort and vaginal retention. Successful completion of this project will demonstrate the technical and commercial feasibility of a novel ambulatory pelvic floor monitoring and feedback device for patients. 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.