Treatment of Male Urinary Incontinence with An Adjustable Implantable Medical Device: Ustrap

Abstract

Introduction and Objectives: Our aim is to develop a device which is simpler, less expensive, but equally or more effective than currently available devices including the artificial urinary sphincter. Method: Based on our knowledge of and experience with other devices we designed the Ustrap. The theoretical advantages of our approach are described as is the development to the current (3rd) version. Results: For version #1, implanted in 6 patients, the 5 year follow up includes 2 improved, 2 unchanged, 2 required AUS. For version #2 implanted in 4 patients, 2 year follow up shows 3 improved, 1 failure. Conclusions: The Ustrap has unique features which distinguish it from current devices. A proposed multicenter prospective clinical trial of version #3 is awaiting approval.