Hornsby

This research aims to evaluate the long-term safety and effectiveness of the Rigicon Infla 10 Three-Piece Inflatable Penile Prosthesis in men with erectile dysfunction ED. ED is a common male sexual condition linked to various health issues such as diabetes, cardiovascular disease, and depression, affecting quality of life. The study follows patients implanted with this device for up to three years to assess its impact on ED treatment. Participants receive the Rigicon Infla 10 inflatable penile prosthesis, which is a three-piece device designed to help men achieve and maintain erections. The study involves a single group of male subjects aged 22 and older who have been implanted with this device. Follow-up visits are scheduled at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months post-implantation to monitor safety and device effectiveness. During the study, participants will have assessments including device-related safety events, an objective axial rigidity test at 12 months, and evaluations of erectile function and self-esteem using standardized questionnaires. Researchers will monitor participants according to the study protocol and usual care for ED and related health conditions. The total participation period spans up to three years with periodic health evaluations and device durability assessments.