Grenoble, France-based UroMems designed the UroActiv system as a smart, automated artificial urinary sphincter (AUS). It treats stress urinary incontinence (SUI). Results from the initial study should support the design and implementation of a pivotal trial in Europe and the U.S.
The study cohort features six men, all of whom underwent the UroActiv implant procedure in either Paris or Nantes, France.
In June, the SOPHIA study successfully met the primary endpoints for its initial male patient. Primary outcomes for the study include successful device activation and the rate of explants and revisions at six months. The first male patient in the SOPHIA study met the primary endpoints by remaining revision-free. This patient also experienced restored social continence.
“We are delighted wi…