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

The goal of this pivotal clinical trial is to evaluate the safety and effectiveness of the SUI-100 device for the treatment of mild-to-moderate stress urinary incontinence (SUI) in females aged 22-70 years. The main questions this study aims to answer are: 1. Does treatment with the SUI-100 device reduce SUI symptoms, as measured by urine leakage. 2. Is the device safe and effective compared to the sham group? Participants will: 1. Be randomly assigned to an active or sham control group in a blinded, multicenter study. 2. Attend treatment visits during the Treatment Phase, with SUI assessments conducted at specific intervals. 3. Enter a 3-month, treatment-free follow-up phase, with SUI assessment. 4. Proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit. The total study duration will last approximately 18 months, with each individual's participation lasting approximately 6-8 months. This study aims to provide robust data on the effectiveness, safety, and durability of the SUI-100 device for treating female 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.