SBIR-STTR Award

Direct to Phase II

Liv Labs has developed a novel, reusable, self-administered silicone pessary for patient-controlled treatment offemale stress urinary incontinence (SUI), a bothersome condition that affects some 27 million American womenover 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 theurethra through soft, vaginal tissue. The device compresses down into a 10mm cylinder for applicator-assistedinsertion and features an integrated finger loop for easy manual removal. Comprising only soft, roundedsurfaces, the spring pessary can be lubricated and is intended for patients with vaginal atrophy who sometimesexperience pain, lacerations, or injury with existing devices. The Liv Labs team has already completed benchtesting, 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 ashigh user satisfaction. During Phase II, Liv Labs will ensure the pessary meets all requirements for pre-clinicaldesign validation. Output will include engineering specifications and drawings; quality system framework; riskassessment; and results for biocompatibility, toxicity, and forces testing. First a controlled, single-use humanfactors 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 ProgramClinic (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 ofevaluative questionnaires, the same participants will then immediately enter a prospective, descriptive study ofpatient-managed device use for a period of six months (Aim 3). The team at Liv Labs comprises late-careerproduct developers with experience inventing medical devices and software, branded consumer products andservices, and technology-enabled, proactive care models for aging in place. The team is closely advised by apanel of practicing urogynecologists and OB/GYNs. The extended development team has collaborated closelywith 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 willprovide millions of women, from all walks of life, a practical, affordable way to self-treat their SUI symptomsand increase their inclination toward fitness.

Public Health Relevance Statement:
Project Narrative Nearly 27 million American women have a current, unmet need for conservative, non-surgical treatment for stress urinary incontinence (SUI); and that number will rise to 35 million by 2060 as the population ages. The proposed research will evaluate the safety, efficacy and usability of a novel, soft spring continence pessary that provides the utility of a reusable, fitted pessary with unprecedented ease of use, physical comfort, and psychological security. The goal is to build widespread adoption of a patient-controlled treatment that improves quality of life and reduces other chronic illness risks while simultaneously reducing demand for expensive clinical care.

Project Terms:
Adoption ; Affect ; Age ; ages ; Anatomy ; Anatomic ; Anatomic Sites ; Anatomic structures ; Anatomical Sciences ; Bladder ; Bladder Urinary System ; urinary bladder ; Chronic Disease ; Chronic Illness ; chronic disorder ; Coughing ; Diagnosis ; Engineering ; Estrogens ; Therapeutic Estrogen ; Exercise ; Exertion ; Feasibility Studies ; Female ; Fingers ; Focus Groups ; Goals ; Health ; Human ; Modern Man ; Incontinence ; Lead ; Pb element ; heavy metal Pb ; heavy metal lead ; Manuals ; Medical Device ; Minor ; Pain ; Painful ; Legal patent ; Patents ; Patient Education ; Patient Instruction ; Patient Training ; Client satisfaction ; Patient Satisfaction ; Patients ; Pelvis ; Pelvic ; Pelvic Region ; Pessaries ; Physical Fitness ; pressure ; Public Health ; Quality of life ; QOL ; Questionnaires ; Research ; Resources ; Research Resources ; Risk ; Running ; Safety ; medical schools ; medical college ; school of medicine ; Self Administration ; Self-Administered ; Silicones ; Sneezing ; Computer software ; Software ; statistics ; Surveys ; Survey Instrument ; Technology ; Testing ; Time ; Tissues ; Body Tissues ; Universities ; Urethra ; urethral ; Stress Urinary Incontinence ; Incontinence when straining ; Stress Incontinence ; Urine ; Urine Urinary System ; Vagina ; Vaginal ; Weight Gain ; Weight Increase ; body weight gain ; body weight increase ; wt gain ; Weight ; Woman ; Laceration ; Walking ; Caregivers ; Care Givers ; promoter ; promotor ; Risk Assessment ; Self Management ; Specialist ; Uncertainty ; doubt ; Caring ; Journals ; Magazine ; Injury ; injuries ; career ; improved ; Left ; Anterior ; Surface ; Acute ; Clinical ; Phase ; Medical ; psychologic ; psychological ; Lifting ; Pelvic floor structure ; Pelvic Floor ; Ensure ; Training ; satisfaction ; Lubricants ; Atrophy ; Atrophic ; Life ; programs ; mechanical ; Mechanics ; Emotional well being ; Feels well ; Normal mental condition ; Normal mental state ; Normal psyche ; Psychological Well Being ; Sense of well-being ; emotional wellbeing ; mental well-being ; mental wellbeing ; psychological wellbeing ; psychological wellness ; self wellness ; sense of wellbeing ; Well in self ; Frequencies ; Severities ; Clinic ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Visit ; Services ; preference ; American ; biocompatibility ; biomaterial compatibility ; consumer product ; experience ; Toxicities ; Toxic effect ; novel ; Participant ; Devices ; Reporting ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Modeling ; Pelvic Floor Muscle ; Cream ; Length ; fitness ; Symptoms ; research clinical testing ; Clinical Evaluation ; Clinical Testing ; clinical test ; Enrollment ; enroll ; Security ; Validation ; follow-up ; Active Follow-up ; active followup ; follow up ; followed up ; followup ; Development ; developmental ; open label ; open label study ; Output ; pre-clinical ; preclinical ; cost ; design ; designing ; novel strategies ; new approaches ; novel approaches ; novel strategy ; Treatment Efficacy ; intervention efficacy ; therapeutic efficacy ; therapy efficacy ; Population ; Prevalence ; prospective ; Stress Tests ; Consumption ; usability ; clinical care ; flexibility ; flexible ; arm ; Institutional Review Boards ; IRB ; IRBs ; symptom treatment ; symptomatic treatment ; treat symptom ; incontinence symptom ; efficacy study ; secondary endpoint ; secondary end point ; primary endpoint ; primary end point ; aging in place ; age in place ; side effect ; Home ;