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 range
22 Years – 77 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of participants with a ≥50% reduction in urine leakage.