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Evaluating SUI-100™, A Non-Invasive Device for the Treatment of Stress Urinary Incontinence

NCT06862648 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2026-04-09

No results posted yet for this 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

  • Stress Urinary Incontinence (SUI)

Interventions

DEVICE

Acoustic Stimulation Therapy Device

The SUI-100 Device is a non-invasive device designed for the treatment of stress urinary incontinence (SUI) in females.

DEVICE

Sham Acoustic Stimulation Therapy Device

The sham intervention uses the same device setup with sham procedures.

Sponsors & Collaborators

  • Acoustic Wave Cell Therapy, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
77 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2026-09-08
Completion
2026-11-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06862648 on ClinicalTrials.gov