The trial evaluates the UroActive smart implant to treat stress urinary incontinence (SUI) in men. Grenoble, France-based UroMems also received approval for the trial from the French National Agency for the Safety of Medicines and Health Products (ANSM).

UroMems’ SOPHIA2 study evaluates the safety and efficacy of the smart automated artificial urinary sphincter (AUS) in treating SUI. Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct in men and bladder neck in women. It’s controlled by a patient’s activity without the need for manual adjustments. This provides patients ease of use and better quality of life compared to other options.