Phase IIB Clinical and Nonclinical Testing of Soft Spring Continence Pessary for Women, in Support of FDA 510(k) Clearance Requirements

Project Summary/Abstract Liv Labs has developed a novel, reusable, self-administered silicone pessary for patient-controlled treatment of female stress urinary incontinence (SUI), a bothersome condition that affects some 29 million American women over the age of 25. Unlike the fitted and disposable pessaries available on the market today, this patent- pending Soft Spring Continence Pessary is a symmetrical, hollow, resilient form placed intravaginally, above the pelvic floor—not to kink the urethra, as other effective devices and surgical procedures do, but rather to gently compress the urethra through soft, vaginal tissue. The device compresses down into a 10mm cylinder for applicator-assisted insertion and features an integrated finger loop for easy manual removal. Comprising only soft, rounded surfaces, the spring pessary can be lubricated for use by patients with vaginal atrophy who sometimes experience pain, lacerations, or injury with existing devices. Liv Labs completed a pilot feasibility study (n=9). Directional efficacy and safety were reported, as well as high user satisfaction. Phase II outcomes included a summative human factors study (Aim 1), FDA Pre-Submission Review, clinical release of device and package design, samples fabrication, a nonclinical testing plan and IRB approval of a pivotal clinical trial plan that responds to FDA feedback. A single-arm, open label, interventional efficacy study is now approved at three sites under Northwestern University’s Integrated Pelvic Health Program (Phase IIB Aim 1). The study will enroll at least 57 symptomatic women diagnosed with SUI and confirming device fit. Study candidates will perform a validated one-hour pad weight test without intervention; if enrolled, they will perform the same test again with intervention. During the at-home study phase, study participants will track leak frequency and side effects, with and without intervention. Quality of life will be measured through validated questionnaires. Those participants who complete the study will be invited to enroll in a subsequent prospective, descriptive study of patient-managed device use for a period of six months (Phase IIB Aim 2). Nonclinical testing will address both intended device use and potential misuse. The core team at Liv Labs comprises late-career product developers with experience inventing medical devices and software, branded consumer products and services, and technology-enabled, proactive care models for aging in place. The extended team includes top-tier consultants in engineering, manufacturing, quality systems, clinical research and regulatory strategy. Once commercialized, the first-ever Soft Spring Continence Pessary will provide millions of women, from all walks of life, a practical, affordable way to self-treat their SUI symptoms and increase their inclination toward fitness.