An intravaginal, wearable device for treating women with pelvic floor myofascial pain

Abstract High tone pelvic floor dysfunction (HTPFD) is a major contributor to chronic pelvic pain, affecting up to 15% of women in the United States. Intravaginal Electrical Stimulation (IES) and focal muscle vibration (FMV) can play pivotal roles in managing muscle pain through distinct mechanisms. IES involves applying low-level electrical currents to stimulate nerves, which can reduce pain perception by disrupting pain signals' transmission to the brain and promotes the release of endorphins, providing short-term relief for muscle discomfort. FMV employs mechanical oscillations to target muscle fibers, enhancing blood flow and relaxing muscle tension. This process can alleviate muscle soreness and aid in recovery after exercise, making it effective in both pain management and performance enhancement. By combining the benefits of IES and vibration in a wearable, intravaginal device for women with HTPFD, individuals with muscle pain can discreetly access a multifaceted approach that addresses pain perception, circulation, and muscle relaxation for pain relief. Bold Type proposes development of an intravaginal, wearable device called “Violet” to provide pelvic floor muscle vibration and electrical nerve stimulation therapy for patients with HTPFD on an “as needed” basis throughout the day. Bold Type specializes in developing connected, wireless medical devices. Our team has decades of product development experience with expertise in 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. Building off these resources we propose the following Specific Aims: 1) Develop the Violet Device to: (1) provide on-demand intravaginal electrical stimulation (IES) and vibration therapy to provide pain relief, and (2) measure and track intravaginal temperature, motion, and position; 2) Develop the Violet software (mobile app and embedded software) to track symptoms, wirelessly control the device, and extract data; and 3) Perform formative usability and preliminary validation testing on a group of 15 healthy women. Completion of these three aims will preliminarily confirm the following: (1) that patients can insert, retain, and remove the Violet device without unacceptable discomfort; (2) that patients can feel the IES and vibration stimulation and adjust their settings; and (3) that the system can accurately measure temperature, motion, and body position and transfer data to a mobile device. Successful completion of these aims will prepare the way for a Phase 2 project where a commercial grade system will be developed under FDA design controls and validated in a longitudinal study to evaluate efficacy and achieve FDA clearance.