UroMems Receives FDA and ANSM Approval to Initiate Groundbreaking Clinical Study for UroActive® in Treating Male Stress Urinary Incontinence
July 17, 2025 – Paris, France – UroMems, a pioneering medical technology company, today announced a significant milestone in its mission to revolutionize the treatment of urinary incontinence. The company has received clearance from both the U.S. Food and Drug Administration (FDA) and the French Agence nationale de sécurité du médicament et des produits de santé (ANSM) to commence a pivotal clinical study for its intelligent implant, UroActive®. This advanced device is designed to address the debilitating condition of stress urinary incontinence (SUI) in men.
The upcoming clinical trial represents a significant step forward in offering a novel, implantable solution for men suffering from SUI, a condition that can profoundly impact quality of life. UroActive® is distinguished by its intelligent design, which aims to provide a more dynamic and personalized approach to restoring urinary control compared to existing treatments.
Stress urinary incontinence, often occurring after prostate surgery or other procedures affecting the pelvic floor, is characterized by involuntary leakage of urine during physical activities that increase abdominal pressure, such as coughing, sneezing, or exercising. While various treatment options exist, many men continue to experience persistent symptoms or face limitations with current therapeutic interventions.
UroMems’ UroActive® implant is engineered to offer a minimally invasive and adaptable solution. While specific details of the implant’s functionality are proprietary, the company has indicated that its intelligent nature allows for potential real-time adjustments or responses to the user’s physiological needs, aiming for enhanced efficacy and comfort. The approval by both the FDA and ANSM underscores the rigorous evaluation process these regulatory bodies undertake to ensure the safety and potential benefit of new medical devices.
The commencement of this pivotal clinical study marks a critical phase in the development of UroActive®, allowing UroMems to gather essential data on the device’s safety, performance, and patient outcomes. The insights gained from this trial will be instrumental in bringing this innovative therapy to market and making it accessible to the many men who can benefit from it.
This development is highly anticipated within the urological community, as it holds the promise of a new paradigm in managing male SUI. UroMems is committed to advancing the field of urological care through cutting-edge technology and is dedicated to a thorough and ethical execution of this crucial clinical study. Further updates on the study’s progress are expected as it unfolds.
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PR Newswire Policy Public Interest published ‘UroMems erhält von der FDA und der französischen ANSM die Genehmigung zum Start einer wegweisenden klinischen Studie mit dem intelligenten Implantat UroActive® zur Behandlung der Belastungsharninkontinenz bei Männern’ at 2025-07-17 15:34. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.