Research Project
10255546
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 27 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 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 and is intended for patients with vaginal atrophy who sometimes experience pain, lacerations, or injury with existing devices. The Liv Labs team has already completed bench testing, focus groups, caregiver assessments, design review with clinicians, and a two-week, IRB-approved, pilot feasibility study with nine symptomatic women. Directional efficacy and safety were reported, as well as high user satisfaction. During Phase II, Liv Labs will ensure the pessary meets all requirements for pre-clinical design validation. Output will include engineering specifications and drawings; quality system framework; risk assessment; and results for biocompatibility, toxicity, and forces testing. First a controlled, single-use human factors study will be held to confirm safe and accurate device use (Aim 1). Then a single-arm, open label, interventional efficacy study will be conducted at Northwestern University?s Integrated Pelvic Health Program Clinic (Aim 2). The study will enroll 50 women diagnosed with SUI by means of an in-clinic Cough Stress Test. Enrolled patients will participate in an 17-day pad weight test, to confirm device efficacy. Upon completion of evaluative questionnaires, the same participants will then immediately enter a prospective, descriptive study of patient-managed device use for a period of six months (Aim 3). The 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 team is closely advised by a panel of practicing urogynecologists and OB/GYNs. The extended development team has collaborated closely with Liv Labs for three years and includes top-tier consultants in engineering, manufacturing, quality systems, clinical testing 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.
