SUI-100 Device for Stress Urinary Incontinence
(SaHARA Trial)
Trial Summary
Will I have to stop taking my current medications?
You may need to keep your current medication dose the same during the trial, especially if you're taking medications for urge urinary incontinence or other drugs that affect incontinence. If you're on oral or vaginal estrogen therapy, testosterone, or certain other medications, you must have been on a stable dose for 3 months before the trial and maintain that dose throughout.
What data supports the effectiveness of the SUI-100™ treatment for stress urinary incontinence?
What safety data exists for the SUI-100 device for stress urinary incontinence?
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for women aged 22-70 with mild-to-moderate stress urinary incontinence. Participants must be able to attend multiple treatment visits and follow-up assessments over a period of 6-8 months. The study excludes specific details not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive active or sham sessions with the SUI-100 Device, with SUI assessments conducted at specific intervals
Follow-up
Participants enter a treatment-free follow-up phase with SUI assessment
Maintenance
Participants proceed to three monthly maintenance treatments, followed by a final SUI assessment at study exit
Treatment Details
Interventions
- SUI-100™
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acoustic Wave Cell Therapy, Inc.
Lead Sponsor