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NCT06862648 · ClinicalTrials.gov registry record · NA
Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence
A NA study of Stress Urinary Incontinence (SUI), sponsored by Acoustic Wave Cell Therapy.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 7
- Study locations
NCT06862648: Recruiting NA study of Stress Urinary Incontinence (SUI), sponsored by Acoustic Wave Cell Therapy.
NCT06862648 is a NA study of Stress Urinary Incontinence (SUI) that is actively recruiting participants, run by Acoustic Wave Cell Therapy. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06862648, a NA study of Stress Urinary Incontinence (SUI), is actively recruiting participants, sponsored by Acoustic Wave Cell Therapy.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 7
- Study locations
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.
Primary Outcome
The proportion of participants achieving at least a 50% reduction in urine leakage as measured by the average of three 24-Hour Pad Weight Tests (µ-24-PWT).
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 |
What NCT06862648 shows while recruiting
NCT06862648 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
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.
NCT06862648 lists 7 locations in 7 states (Arizona, Florida, Idaho).
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).
What interventions are being tested in trial NCT06862648?
The interventions under investigation include: Acoustic Stimulation Therapy Device (DEVICE), Sham Acoustic Stimulation Therapy Device (DEVICE).
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.
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.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence (SUI)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06862648's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,257 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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