Long-Term Study of the Rigicon Infla10 Inflatable Penile Prosthesis for Treating Erectile Dysfunction in Men

What this Trial Is About

Erectile dysfunction ED is a common male sexual problem linked to reduced quality of life and often occurs alongside conditions like diabetes, hypertension, and cardiovascular disease. Researchers are evaluating the long-term safety and effectiveness of the Rigicon Infla10ae Inflatable Penile Prosthesis IPP in men with ED. This study focuses on patients implanted with the Rigicon Infla10ae Pulsetrade Dynamic Inflatable Penile Prosthesis and follows them for up to three years after implantation. The study involves male participants aged 22 and older who receive the Rigicon Infla10ae three-piece inflatable penile prosthesis as a treatment for ED. There is a single study group which will be monitored after receiving the device. The device is patient-activated to help achieve and maintain an erection, and the study assesses its safety and function over time. Participants will have regular follow-up visits over three years to complete tests and assessments. Researchers will monitor for any device- or procedure-related adverse events during the first 12 months and evaluate penile rigidity at 12 months. Other measures include tracking revision surgeries, erectile function scores, self-esteem scales, and adverse events throughout the study period. Participants must agree to follow all study protocols and attend scheduled visits.

Evaluation of the Rigicon Infla10® Inflatable Penile Prosthesis (IPP) for Erectile Dysfunction