Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

Stress urinary incontinence, characterized by the involuntary loss of urine during activities that increase intra-abdominal pressure, affects approximately 50% of women with urinary incontinence and significantly impacts their quality of life. The SUI-100 device offers a novel, low-risk alternative to existing treatments, addressing a critical need for effective and conservative options. Study Design: The trial employs a randomized, blinded, sham-controlled, multi-center approach with an option for cross-over for participants randomized to sham. Study Aim: The study aims to determine the safety and efficacy of the study product in treating SUI. The study device is non-surgical and non-invasive. Primary and Secondary Outcomes: The study's primary objective is to determine whether treatment with the device reduces urine leakage by ≥50%, as measured by the 24-Hour Pad Weight Test, compared to the sham arm. Safety Monitoring: Safety assessments will be conducted throughout the study, with all adverse events (AEs) and adverse device effects (ADEs) documented and graded for severity. Key Distinctions: This trial is unique in its use of a non-invasive device that may offer a low-risk alternative to invasive treatments like urethral slings and radiofrequency therapy. The study's design, incorporating a sham-controlled, blinded methodology, ensures rigorous evaluation of the device's efficacy and safety.