Grenoble, France-based UroMems designed its smart UroActive implant to treat stress urinary incontinence (SUI). The company says it’s the first smart, automated artificial urinary sphincter (AUS) to treat SUI.
Powered by a MyoElectroMechanical system (MEMS), UroActive goes into the urethral duct. 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 better options, according to a news release.
The first-of-its-kind clinical feasibility study supports the design and implementation of a pivotal trial in Europe and the U.S.
All six men in the study received their implants at least seven months ago — and up to 15 months. The study demonstrated that devices operated as expected with no need for revision or explant. Additionally, UroMems received “extremely positive” follow-up on the secondary outcomes measures. Those include leak rate values and patient quality of life questionnaires.
“The very compelling results of this first-in-man clinical study demonstrate the high potential of our technology and pave the way for larger clinical trials that will allow us to demonstrate all the benefits we are expecting to offer patients suffering from debilitating SUI,” said Hamid Lamraoui, UroMems CEO and co-founder. “We could not have reached this important milestone without the enthusiastic participation of the men in this initial study cohort. We’re extremely grateful to them for being a vital part in bringing this potentially revolutionary treatment to market.”
