Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence (NCT06862648) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
United States130 participantsStarted 2025-03-25
Plain-language 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.
Who can participate
Age range22 Years – 77 Years
SexFEMALE
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Inclusion criteria
✓. Females aged 22-70 years
✓. MESA-UIQ SUI score must exceed MESA-UIQ UUI score
✓. Investigator diagnosis of SUI at Baseline Study Visit A
✓. µ-24-PWT \>10 grams, and ≤74 grams
✓. Positive PST (observed urine loss during coughing or Valsalva maneuver)
✓. Able to independently read and willing to provide written informed consent and comply with all study visits and assessments required by study protocol
✓. Able to independently read and complete all questionnaires and diaries provided in English
✓. Negative urine test for urinary tract infection (UTI)
Exclusion criteria
✕. Body Mass Index (BMI) \>35
✕. µ-24-PWT ≥ 75 grams
✕
What they're measuring
1
Percentage of participants with a ≥50% reduction in urine leakage.