Infection rates and risk factors following inflatable penile prosthetic implantation: an analysis of real-world hospital data.

Background: Erectile dysfunction significantly affects quality of life, and while inflatable penile prosthesis (IPP) is a definitive treatment option, post-operative infections remain a concern, requiring better understanding of patient-level risk factors.

Aim: This study sought to analyze infection rates following IPP and to identify risk factors associated with infection using real-world data.

Methods: Retrospective analysis was performed among patients aged ≥18 who underwent IPP insertion between 2016 and 2022 in the U.S using the Premier PINC AI™ Healthcare Database. Cox proportional hazards regression was used for statistical analysis.

Outcomes: The primary outcome was infection rate post-IPP over time; twelve known risk factors examined included: older age (≥75), smoking status, positive human immunodeficiency virus status, diabetes (Type 1 and 2, with and without comorbidities), history of pelvic radiation, history of urinary diversion, spinal cord injury, obesity, concomitant circumcision, and Peyronie's disease.

Results: Among 18 475 males with IPP surgery, the overall infection rate post-IPP was 3.1% at a median follow-up of 3 years, with 2.5% occurring within the first 6 months. The infection rate at 3 years was significantly higher for patients with at least one risk factor compared to those without any (3.9% vs. 2.8%, HR 1.40 [95% CI 1.14, 1.72]). Patients with ≥3 risk factors had the highest infection rate (5.6% vs. 2.8%, HR 2.18 [95% CI 1.26, 3.75]). Among 12 risk factors analyzed, five were significantly and positively associated with infection rate: Type 2 diabetes with comorbidities (4.7% vs. 3.0%, HR 1.56 [95% CI: 1.14, 2.1.3]), Type 2 diabetes without comorbidities (4.3% vs. 3.0%, HR 1.38 [95% CI: 1.06, 1.79]), spinal cord injury (9.8% vs. 3.0%, HR 2.81 [95% CI: 1.33, 5.93]), obesity (5.2% vs. 3.0%, HR 1.74 [95% CI: 1.26, 2.41]), and concomitant circumcision (6.6% vs. 3.0%, HR 2.01 [95% CI: 1.04, 3.89]).

Clinical implications: The overall rate of infection post-IPP was low, with most infections occurring within the first 6 months, particularly among higher risk patients, highlighting the importance of close early postoperative monitoring.

Strengths & limitations: Strengths include the large patient population and data from diverse clinical settings. However, hospital claims data may lack granularity and may have coding errors/misclassifications.

Conclusion: This large observational study confirmed the low rate of infection post-IPP overall and that certain risk factors such as Type 2 diabetes, spinal cord injury, obesity, and concomitant circumcision significantly increased its likelihood, suggesting that optimizing specific risk factors preoperatively could enhance outcomes and improve patient care.