A global, propensity-score matched analysis of patients receiving inflatable penile prostheses and the risk of complications, infections, and re-interventions.

Background: Over 25,000 men undergo inflatable penile prosthesis (IPP) placement yearly to treat erectile dysfunction (ED). Although various comorbidities are hypothesized risk factors for complications, this remains incompletely understood. Our objective was to utilize multi-institutional data to characterize risk for reintervention, complications, and infections in patients with common suspected risk factors undergoing IPP placement.

Methods: We queried the TriNetX database for adult men who underwent IPP placement from 2003-2023 utilizing Current Procedural Terminology (CPT) codes. We examined the impact of diabetes mellitus (DM), hypertension (HTN), nicotine use, radiation therapy (RT), radical prostatectomy (RP), and urethral surgery [urethroplasty, artificial urinary sphincter (AUS), male urethral sling (MS)] on clinical outcomes defined by International Classification of Diseases 10th Revision (ICD-10) codes. Our primary outcome was need for reintervention based on CPT codes. Secondary outcomes included overall rates of complication and infection utilizing ICD-10 codes. Analytics were performed using TriNetX to calculate risk ratios (RRs) and Kaplan-Meier (KM) survival. We evaluated outcomes overall and for each individual comparison cohort using the remaining demographic variables to perform propensity score matching (PSM).

Results: In a total of 11,026 patients there was an overall 13.5% risk of undergoing at least one reintervention, with some undergoing multiple based on CPT codes. KM analysis showed a median IPP survival of 18.2 years and a projected 10- and 20-year survival probability at 70.6% and 48.4% respectively. Overall complication rate was 19.3% with a 5.2% rate of infection based on ICD codes. Patients with history of urethral surgery were at higher risk of both IPP complication and re-intervention. When further analyzing type of re-intervention, patients with a history of smoking, prior RP, and prior AUS/MS placement had higher rates of device removal. Patients with a history of diabetes were less likely to undergo IPP replacement at the time of explant. There were no identified risk factors for IPP infection.

Conclusions: This is the largest cohort of patients ever evaluated and can help guide patient selection and counseling. There was a higher rate of IPP complications than previously reported, but this may be due to different reporting parameters. History of prior urethral surgery conferred a higher risk of complications and re-intervention. These results can help guide patient selection and counseling.