Hornsby

Erectile dysfunction (ED) is a common condition in men, often associated with reduced quality of life and linked to health issues like depression, diabetes, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10ae Three-Piece Inflatable Penile Prosthesis to treat ED. This study follows patients who receive this prosthesis for up to three years after implantation to gather comprehensive safety and efficacy data. Participants receive the Rigicon Infla10ae device, a patient-activated inflatable penile prosthesis designed to help achieve and maintain an erection. The study includes several follow-up visits at 14 days, 6 weeks, 6 months, 12 months, 18 months, 24 months, and 36 months after the procedure. During these visits, participants are monitored according to study protocols and standard care for ED and related health conditions. Throughout the study, researchers assess safety by tracking adverse events related to the device or procedure over a 12-month period. Effectiveness is measured by an objective test of penile rigidity at 12 months. Participants complete follow-up visits and tests to monitor outcomes and device function. The total study duration includes up to three years of observation to ensure long-term safety and performance.