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Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
NCT06862648 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DEVICE Acoustic Stimulation Therapy Device
- DEVICE Sham Acoustic Stimulation Therapy Device
Study Locations (7)
Arizona
- Arizona Gynecology Consultants — Phoenix
Florida
- Clinical Research of Central Florida — Winter Haven
Idaho
- Advanced Specialty Research — Boise
Kansas
- Cypress Medical Research Center — Wichita
Montana
- Boeson Research GTF — Great Falls
Nevada
- Foundation for Female Health Awareness — Las Vegas
Ohio
- Helios Clinical Research — Middleburg Heights
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-03-25 |
| Est. Completion | 2026-11-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06862648
The ClinicalTrials.gov registry entry for NCT06862648 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 130 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Acoustic Wave Cell Therapy, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Stress Urinary Incontinence (SUI) appearing as the primary indexed condition, and to 2 interventions — of which Acoustic Stimulation Therapy Device is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06862648 reports 7 study locations spanning 7 distinct geographic areas — top geographies include Arizona, Florida, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06862648 about?
NCT06862648 is a clinical study titled "Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence". 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...
What is the current status of trial NCT06862648?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2025-03-25. Estimated completion is 2026-11-09.
What conditions does trial NCT06862648 study?
This clinical trial studies the following conditions: Stress Urinary Incontinence (SUI). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06862648?
The interventions under investigation include: Acoustic Stimulation Therapy Device (DEVICE), Sham Acoustic Stimulation Therapy Device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06862648?
This trial is sponsored by Acoustic Wave Cell Therapy, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06862648 being conducted?
This trial has 7 study locations across Arizona, Florida, Idaho, Kansas, Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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