Inflatable penile prostheses long-term revision and removal rates compared to semi-rigid penile prostheses: a...

Reoperation rates following penile prosthesis implantation are influenced by patient- and device-related factors. While previous studies from high-volume centers have reported 5 to 10-year reoperation rates of 11%-16%, these findings may not fully capture outcomes in broader, real-world populations.

This study aimed to assess long-term complication and reoperation rates for penile prostheses using a global electronic health records database.

We conducted a retrospective observational analysis using electronic health records and insurance claims from the TriNetX Global Health Research Network, covering May 2005 to May 2025. Men aged 18-90 who underwent initial implantation of either an inflatable or semi-rigid penile prosthesis (SRPP) were included. Statistical comparisons between cohorts used two-sample Z-tests, with significance set at P < .05.

Outcomes included device revision or reimplantation, explantation, infection, mechanical failure, and displacement.

Among 29 385 men, 18 749 received inflatable prostheses and 10 636 received semi-rigid devices. At 5 years, the revision/removal rate was not significantly lower for inflatable devices (13.9%) compared to semi-rigid implants (13.7%; P < .77). Total explantation rates were lower for inflatable prostheses at 5 years (6.5% vs. 8.4%, P < .00001). Mechanical breakdown was more common in the inflatable cohort at 5 years (9.1% vs. 6.7%; P ≤ .0001). There was also a significantly higher rate of device displacement for inflatable prostheses at 5 years (2.3% vs. 1.6%; P = .002). There were no differences in infection rates between devices over time.

This analysis found that inflatable penile prostheses (IPPs) are associated with similar long-term revision and lower explantation rates compared to semi-rigid devices, but more prone to mechanical breakdown and displacement. These findings support the use of inflatable prostheses in appropriate patients seeking lower rates of device removal and underscore the importance of real-world data in surgical decision-making.

The strengths of this study include its large sample size, applicability, and the use of a global clinical dataset integrating claims and electronic health record data to reduce missing information. However, several limitations should be acknowledged. TriNetX does not account for variation in surgical technique, device manufacturer, or surgeon experience. In addition, reliance on administrative codes may underreport complications or omit clinical nuances. Retrospective and observational studies are also limited by inherent biases, incomplete data, and inability to establish causality, which constrain the interpretation.

In this large-scale, real-world analysis, IPPs were associated with similar long-term revision and significantly lower removal rates compared to SRPPs.