Tests treatment safety and results for Stress Urinary Incontinence (SUI)
Official title A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)
ClinicalTrials.gov ID: NCT06968741
What this study is testing
- What it's testing
- Prospective, multicenter, single-arm study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, men only
You may be able to join if
- Male people aged ≥ 22 years old
- Able to read, comprehend and willing to sign an informed consent form
- Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator
- Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed...
You likely can't join if
- Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary...
- Poor candidate for surgical procedures and/or anesthesia, as determined by investigator
- Currently implanted with an Active Implantable Medical Device (AIMD)
- Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Stanford, California, United States
- Bloomington, Minnesota, United States
- Rochester, Minnesota, United States
- Charlotte, North Carolina, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Virginia Beach, Virginia, United States
- Lille, France
- Marseille, France
- Nantes, France
- Paris, France
- Pierre-Bénite, France
- Rennes, France
- Rouen, France
- Suresnes, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Stanford, California, United States; Bloomington, Minnesota, United States; Rochester, Minnesota, United States; Charlotte, North Carolina, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.