Intravaginal device for the treatment of pelvic pain and dyspareunia in female cancer survivors

Summary: More than half of female cancer survivors will experience chronic pelvic pain and dyspareunia (painful intercourse) due to their cancer treatments. As the number of cancer survivors continues to grow, so too will the number of women in need of effective treatments for this life-altering condition. Pelvic floor physical therapists currently use several different devices during in-clinic and at-home therapy (vaginal dilators, pelvic wands, vibration devices) but these devices are unregulated, lack appropriate ergonomics, and do not consider comprehensive functionality, patient-specific needs, and the physical challenges common to cancer survivors. Survivors seek an effective multimodal solution that also provides them with the knowledge, skills, and confidence to advocate for their own sexual health. Cervu, Inc. is developing a patent-pending intravaginal device for the highly individualized needs of female cancer survivors that is uniquely designed for dilation, vibration, myofascial release, and trigger point massage therapies. To date, prototype form factor designs have been 3D printed and mailed to patients and providers through multiple rounds of user testing, resulting in down-selection to a candidate design for further development. The objective of this Phase 1 SBIR proposal is to confirm feasibility of function within the confines of the candidate form factor, and to acquire further user feedback prior to design freeze for first-in-human studies. Aim 1. Develop and validate a functional alpha prototype. We will collaborate with design and manufacturing partners to (1) resolve remaining design questions such as selecting appropriate materials, specifying eccentric rotating mass vibration motor and electrical components, and finalizing the handle-dilator attachment mechanism; (2) manufacture a minimum viable product; and (3) validate function agreement with specifications through extensive bench testing. Goals: (1) Device meets form and function specifications including handle and dilator size and curvature tolerance, handle pitch and roll range of motion, vibration frequency, charging speed, visual indicators, dilator durometer, handle attachment/detachment force, weight distribution, and quality consistency; (2) Production of 5 alpha prototypes that meet or exceed specifications. Aim 2. Demonstrate ability of alpha prototype to meet user needs. We will validate design form agreement through formative user testing in 10 total subjects including pelvic floor physical therapists and female cancer survivors with dyspareunia. Subjects will receive prototypes and will be interviewed on the specific device features as well as anticipated ability to perform therapy. Goal: More than 80% of users rate each feature ≥ 3 on a 5-point Likert scale. The proposed work is expected to demonstrate that a functional device can be implemented within a form factor that ensures user acceptance. Impact: This device has the potential to transform dyspareunia treatment, one of the most common conditions affecting quality of life in female cancer survivors.