Abstract

Abstract Introduction Erectile dysfunction affects at least 40 million men in the United States, with inflatable penile prosthesis (IPP) used as a successful intervention in more than 25,000 men per year. Although common medical comorbidities are hypothesized to be risk factors for infections or complications, this too remains incompletely understood. Large scale, multi-institutional research may help urologists better understand the risks and rates of complications following IPP. Objective To characterize risk for reintervention, complications, and infections in patients with common suspected risk factors undergoing IPP placement in a multicenter global research network. Methods TriNetX is a research network of real-time data from 58 Healthcare Organizations globally. We queried the network for adult men with IPP implant from 2002-2022. We examined select outcomes for the general populations. We also assessed select outcomes for cohorts based on medical comorbidities that were diagnosed prior to IPP. These comorbidities included diabetes mellitus, hypertension, nicotine use, radiation, prostatectomy, urethral surgery, and organ transplant history. Propensity score matching was performed using these variables and excluding the comorbidity of interest for each cohort. International Classification of Disease Tenth Edition (ICD-10) and Current Procedural Terminology (CPT) codes were used to define cohorts and outcomes. Our primary outcome was the need for reintervention, defined here as revision, removal, or replacement at any point after implantation. Secondary outcomes included overall rates of device complication and infection. Analytics were performed using TriNetX software to calculate demographic information, odds ratios (OR), and z-test. The analysis was run on June 13, 2022. Results The study included 10,094 patients with an IPP from 2002 to 2022. The average index age was 62 +/− 11 and the racial demographics were 22% black and 58% white. The general population had a reintervention rate of 9.9%. The rate of complication was 18.8% with a 4.9% rate of infection. Full results are included in Table 1. No comorbidity diagnosed at the time of IPP had a significant association with higher rates of reintervention, complications, or infections. Conclusions Patients had higher rates of IPP complications than previously reported, but this may come from different reporting parameters used in this study. Notably, none of hypothesized comorbidities diagnosed at the time of IPP led to higher rates of reintervention, complications, or infections. Based on this data, the assessed comorbidities are not a contraindication for IPP. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific and Coloplast.

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