NCT06862648

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

Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Acoustic Wave Cell Therapy, Inc. · Industry
• Sex: Female
• Age: 22 Years – 77 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Stress Urinary Incontinence (SUI)

Interventions

Type	Name	Description
DEVICE	Acoustic Stimulation Therapy Device	The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.
DEVICE	Sham Acoustic Stimulation Therapy Device	The sham intervention uses the same device setup with sham procedures.

Timeline

• Start date: 2025-03-25
• Primary completion: 2026-09-08
• Completion: 2026-11-09
• First posted: 2025-03-06
• Last updated: 2026-04-09

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study