Abstract Introduction Penile prostheses can be placed in men with a history of priapism who develop erectile dysfunction, or as initial management of acute ischemic priapism. However, little is known about long-term complications associated with prostheses in these men. Objective To assess the risk of penile prosthesis complications in men with a history of priapism. Methods We searched the TriNetX insurance claims database to create a cohort of men ages ≥16 years old with 1) a diagnosis of priapism (ICD-10: N48.4), 2) a diagnosis of erectile dysfunction (ICD-10: N52), and 3) had undergone prosthesis placement (insertion of penile prosthesis inflatable and self-contained [CPT: 54401], insertion of semi-rigid penile prosthesis [CPT 54400], or insertion of multiple component inflatable penile prosthesis [CPT: 54405]). Three complications were assessed: penile prosthesis infection (ICD-10: T83.61), penile prosthesis mechanical breakdown (ICD-10: T83.410A), and penile prosthesis displacement or migration (ICD-10: T83.420). Rates of and duration to IPP removal (CPT: 54415-17, 54406, 54410-11) were also assessed. To compare rates of complications, the priapism cohort was compared to a cohort of men with a diagnosis of erectile dysfunction and prosthesis placement but without a history of priapism or corpora cavernosal irrigation, matched by age, race, diabetes status, and obesity (E66). When assessing risk of prosthesis complications, we utilized 1:1 greedy nearest-neighbor propensity score matching to control for confounding variables. Results A total of 665 men were identified with a diagnosis of priapism and erectile dysfunction who subsequently received a penile prosthesis. A control group of 31,345 patients with erectile dysfunction and a penile prosthesis but without priapism or history of irrigation was identified, and ultimately 660 men in the case and control cohorts were matched by age, race, diabetes status, and obesity. Men of with a history of priapism were more likely to experience penile prosthesis infection (5.0% vs 2.7%; Risk Ratio (RR): 1.83, 95% Confidence Interval (CI) 1.04-3.22) and mechanical breakdown of the prosthesis (7.3% vs 3.8%, RR: 1.92, 95%CI 1.20-3.08). There was no difference in the rate of penile prosthesis displacement or migration (3.5% vs 2.4%, RR: 0.76, 95%CI 0.77-2.70). Overall rates of penile prosthesis explantation were higher in men with a history of priapism 14.6% vs 8.4% (RR: 1.73, 95%CI 1.27-2.36). Rates of early explantation (within 6 months of placement) were similar between the two groups, 3.3% vs 2.9% (RR: 1.16, 95%CI 0.63-2.11). Rate of explantation of semi-rigid prostheses were significantly higher in men with a history of priapism, 27% vs 9.6% (RR: 2.54, 95%CI 1.62-3.93). Of the 17 men undergoing explantation of semi-rigid prosthesis with history of priapism, only 4 men (23%) went on to have a 3-piece penile prosthesis placed. Conclusions In this US claims-based database comparison between prosthetic complications in men with and without a history of priapism, men with priapism were more likely to experience infection, mechanical breakdown and explantation. There was no difference in rate of device displacement or migration, or in timing of device explantation. This real-world data provides context for counseling men with priapism who undergo prosthesis placement. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Urogen Pharma, Janssen Global Services, Regeneron Pharmaceuticals
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