Artificial Urinary Sphincter for Stress Incontinence

(SOPHIA2 Trial)

This trial tests a new device called the UrOActive® Artificial Urinary Sphincter (AUS) to assist men with stress urinary incontinence, which causes urine leakage during activities like coughing or exercising. The goal is to determine if this device can effectively control leaks and enhance daily life for those affected. Men who have experienced stress urinary incontinence for at least six months and are suitable candidates for surgery may qualify to participate. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance treatment options for stress urinary incontinence.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that the UroActive® Artificial Urinary Sphincter (AUS) holds promise for treating stress urinary incontinence (SUI). In one study involving six men with severe SUI, the device received positive feedback over a year. Patients reported improvements in their quality of life, and no major safety issues arose during that period.

The UrOActive® Artificial Urinary Sphincter (AUS) is unique because it offers a novel, mechanical approach to managing stress incontinence, a condition where urinary leakage occurs during physical activities. Unlike existing treatments like pelvic floor exercises, medications, or traditional surgical options which may not fully address the issue for everyone, the UrOActive AUS provides a direct, physical solution by mimicking the function of a natural urinary sphincter. Researchers are excited about this treatment because it has the potential to significantly improve the quality of life for individuals by offering more consistent and reliable control over urinary flow, reducing the need for lifestyle adjustments or frequent medical interventions.

Studies have shown that the UroActive® Artificial Urinary Sphincter (AUS), which participants in this trial will receive, holds promise for treating stress urinary incontinence (SUI). One study safely placed the device in men, demonstrating effectiveness for up to a year. Another study confirmed its safety and effectiveness, with positive results observed six months after activation. Early results in women also indicated success, suggesting the device could benefit both men and women. Overall, these studies suggest that the UroActive® AUS could enhance bladder control and quality of life for individuals with SUI.¹⁵⁶⁷⁸