A device to treat high-tone pelvic floor dysfunction in women

Abstract Bold Type is developing the “SmartWand”, an interactive, connected pelvic floor system (device and mobile app) to guide patients through pelvic floor physical therapy (PT) in the privacy of their home. PT is a highly effective and first-line treatment for high tone pelvic floor dysfunction (HTPFD), a major contributor to chronic pelvic pain (CPP), affecting up to 15% of women in the United States. Despite proven effectiveness, only 20% of women complete the PT treatment course, which includes a home exercise component with an external and internal exercise regimen. Women report limitations in continuing PT as time, cost, access to therapy, the lack of direct feedback from the home program and the inability to measure progress at home. Bold Type’s team has decades of product development experience with medical devices, quality, and regulatory affairs. We have developed proprietary hardware and software development kits that allow us to design and implement medical devices efficiently by leveraging reusable subsystems that are designed and documented to comply with FDA regulations. To meet the critical need for accessible and improved PT, we hypothesize that: (1) an ergonomic wand design will improve usability, (2) an innovative system for performing PT can be developed that provides guidance and biofeedback to physical therapists and patients; and (3) patients will be able to effectively perform PT using the guidance and biofeedback provided by the platform. We propose the following Specific Aims for this project: 1) Finalize the wand design from three preliminary design prototypes using human factors validation testing. A formative usability evaluation of three preliminary wand prototypes will be conducted in 15 mechanical wand experienced HTPFD patients to identify preferred design features. We will use simulated-use testing under the supervision of a pelvic floor physical therapist and systematically collect data from test participants using the unpowered device prototype; 2) Develop a wireless, handheld “SmartWand” and mobile app that (1) records pressure and location (depth and orientation) in the female pelvis in relation to the pelvic floor muscles, (2) provides the user audio and visual feedback on wand pressure, position, and orientation, and (3) transfers data to a database for storage and analysis; and 3) Validate the system developed in Specific Aim 2 on a group of 10 healthy women and 10 women with HTPFD. Women rt18 years will be recruited by Grace Physical Therapy and therapists assigned to perform pressure pain thresholds and instruct on wand use. The success metric for Aim 3 is that with guidance from the app, the participants will be able to perform wand exercises with minimal variance as compared to measurements made by the PT (within 15% of applied pressure, 5 degrees of angle/orientation and within 8 mm of insertion depth).