A preliminary first-in-human study has evaluated the feasibility, safety, and effectiveness of the UroActive electronic artificial urinary sphincter in six men with stress urinary incontinence (SUI). The device The UroActive is an electronically controlled artificial urinary sphincter comprising an occlusive cuff (OC), a control unit (CU), and a patient remote control (PRC). The OC encircles the urethra and is connected to the CU, which is implanted in the abdomen anterior to the fascia. The CU contains electronic components, software, a pressure sensor, a pump, a reservoir, and a battery.
It inflates or deflates the cuff by dispensing or withdrawing sterile isotonic saline solution. Using the PRC, patients can initiate voiding, adjust pressure settings, activate or deactivate the device, and monitor the battery status. Key findings Device implantation and activation were successful inβ¦