Erectile Dysfunction Clinical Trial
Official title:
IT Matters: The Erectile Restoration Registry
The primary objective of the It MATTERS registry is to assess erectile function at 6 months, post implantation of an It MATTERS Study Penile Prosthesis, demonstrating an improvement in quality of life from baseline.
The study is a post-market study on a newly released device and is part of the planned postmarket clinical follow-up (PMCF) of the device. Adult males with moderate to severe erectile dysfunction (IIEF-EF domain score 1-16) who meet the indications for surgical correction of erectile dysfunction will be included. The purpose of this study will be to assess the impact of the Tactra malleable prosthesis on quality of life in men with erectile dysfunction through use of the International Index of Erectile Function, Erectile Function Score (IIEF-EF). ;
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