Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
Public ClinicalTrials.gov record NCT06862648. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Pivotal Study of the SUI-100™ for the Treatment of Stress Urinary Incontinence (SUI): A Nonsignificant Risk (NSR) Device (SaHARA) Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06862648
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 130 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 22 Years to 77 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2025
- Primary completion
- Sep 7, 2026
- Completion
- Nov 8, 2026
- Last update posted
- Apr 8, 2026
2025 – 2026
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Gynecology Consultants | Phoenix | Arizona | 85016 | — |
| Clinical Research of Central Florida | Lakeland | Florida | 33805 | — |
| Advanced Specialty Research | Boise | Idaho | 83702 | — |
| Advanced Specialty Research | Meridian | Idaho | 83646 | — |
| Cypress Medical Research Center | Wichita | Kansas | 67226 | — |
| Boeson Research GTF | Great Falls | Montana | 59405 | — |
| Foundation for Female Health Awareness | Las Vegas | Nevada | 89148 | — |
| Helios Clinical Research | Middleburg Heights | Ohio | 44130 | — |
| Helios Clinical Research (TX) | Katy | Texas | 77494 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06862648, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2026 · Synced Sep 1, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06862648 live on ClinicalTrials.gov.