Immunosuppression and risk of penile prosthesis complications: evidence from a large healthcare database

Erectile dysfunction (ED) is common among men with solid organ transplant or other conditions requiring immunosuppression. Concern exists that immunosuppression status increases risk of penile prosthesis complications.

To compare the incidence of complications following penile prosthesis placement (PPP) in men receiving immunosuppression versus those not receiving immunosuppression.

Using data from the TriNetX Research Network, we performed a retrospective cohort analysis to assess post-penile prosthesis complication rates in men older than 18 whose first recorded implant occurred after 2016. Men with an active immunosuppression within the 90 days prior to surgery were compared to a control cohort without a history of immunosuppression or solid organ transplantation. Rates of outcomes were compared via cumulative incidence curves and Cox proportional hazards models. Groups were compared before and after propensity score matching for possible confounders.

Outcomes included infection-related events, mechanical complications, pain, hemorrhage, removal without replacement, and removal with replacement. Composite categories included any complication, any reintervention by current procedure terminology (CPT) code and any related diagnosis by ICD-10 code.

After exclusions, 8135 controls (non-immunosuppressed [non-IS]) and 475 IS patients were included in the primary comparison. IS patients had significantly higher baseline comorbidities. IS patients were not at significantly increased risk of infection-related complications (HR 0.90 [95% CI, 0.60-1.34], P = .6), surgical reintervention (HR 1.10 [95% CI, 0.82-1.47], P = .5), or any related complication diagnosis (HR 0.91 [95% CI, 0.62-1.33], P = .6). Results remained not statistically significant after propensity score matching.

Penile prosthesis appears to be a safe treatment option for ED in IS patients, with no significant increase in infection or related complications; however, confidence intervals indicate the true risk could range from modestly lower to modestly higher. These findings should not be used to alter existing standards of patient selection or perioperative management, and continued vigilance remains warranted in this population.

These data represent complication rates from a large dataset, providing comprehensive data and broad application of findings. However, our analysis is limited by inherent challenges to claims-based database research such as reliance on the accuracy of ICD-10 diagnoses and CPT/RxNorm coding in addition to the low incidence of these recorded outcomes and limited statistical power.

History of immunosuppression within 90 days of surgery does not appear to confer significantly increased risk of post-PPP complications including infection, though careful patient selection and perioperative management remain essential.