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Abstract Introduction Treatment methodology for erectile dysfunction can vary from surgeon to surgeon. The It MATTERS registry has been developed to align prospective, long-term, real-world outcomes with current clinical practice. It MATTERS is an immediate avenue (following market approval of a product) to collect and monitor real-world data on existing and future innovation, with respect to Boston Scientific’s penile prostheses (2- and 3-piece inflatable, and malleable), Rear Tip Extenders, surgical tools (sterile and non-sterile), accessories, kits, and all included components. This includes, but is not limited to, the Furlow Insertion Tool, Disposable Dilators, Sizers, Insertion Package (tubing passers), Proximal Tool, Quick Connect Assembly Tool, AMS Closing Tool, and the Deactivation Package. Objective Description of a real-world registry that evaluates erectile function, post-penile prosthesis implantation, over time. Methods It MATTERS is a single-arm, prospective, multi-center registry with follow-up occurring post-surgery and at 6 months, 12 months, and annually, thereafter. Subjects will serve as their own control; follow-up assessments will be compared to values collected at baseline. The registry is designed to capture the wide array of immediate, post-surgery follow-up schedules without dictating a specific visit cadence. Following signature of an informed consent, eligible subjects are treated with a Boston Scientific penile prosthesis. The registry will enroll over the lifetime of each device, allowing for up to 150 active subjects in follow-up, per device. Results Registry endpoints include measuring change in erectile function from baseline using the Erectile Function domain of the International Index of Erectile Function (IIEF-EF), change in depressive symptoms using the Patient Health Questionnaire (PHQ)-9, overall sexual function using the IIEF Total Score, and change in work productivity using the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI:GH). Additional measures, amongst many, include patient-reported device satisfaction using a 5-point Likert scale and adverse events. For each penile prothesis group in the registry, a two-sided 95% confidence interval may be constructed for interpreting the change in IIEF-EF score over time compared to baseline. Descriptive statistics will summarize continuous and categorical variables. Currently, 51 penile prosthesis implants have been completed: Tactra™ Malleable Penile Prosthesis (n = 34), Spectra™ Concealable Penile Prosthesis (n = 9), and AMS Ambicor™ Inflatable Penile Prosthesis (2-piece; n = 8). Conclusions The It MATTERS registry builds on over 50 years of erectile dysfunction patient care and data. It will allow for the comparison of outcomes and clinical practice on legacy and new market-approved products, which will pave the way for future innovation and advancing patient care. Disclosure Yes, this is sponsored by industry/sponsor: Industry initiated, executed, and funded registry. All authors act as consultants, employees, or shareholders of Boston Scientific Corporation. Clarification: Industry initiated, executed and funded study. Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific Corporation.
Khera et al. (Fri,) studied this question.