Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence (NCT06862648)
Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Arizona Gynecology Consultants — Phoenix, Arizona
Age range: 22 Years to 77 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Arizona Gynecology Consultants — Phoenix, Arizona
- Clinical Research of Central Florida — Lakeland, Florida
- Advanced Specialty Research — Boise, Idaho
- Advanced Specialty Research — Meridian, Idaho
- Cypress Medical Research Center — Wichita, Kansas
- Boeson Research GTF — Great Falls, Montana
- Foundation for Female Health Awareness — Las Vegas, Nevada
- Helios Clinical Research — Middleburg Heights, Ohio
- Helios Clinical Research (TX) — Katy, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Stress Urinary Incontinence (SUI)
- Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients — Toronto, Onatrio
- A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS) — Los Angeles, California
- Managing Impact-related Leakage During Exercise Using Intravaginal Support — Ottawa, Ontario
Explore by condition: All Stress Urinary Incontinence (SUI) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.