Abstract
Like all surgeries, penile prosthesis implantation (PPI) has the potential for both postoperative complications and suboptimal patient satisfaction. In order to assess risk factors for poor satisfaction, we reviewed patients who had been prospectively recruited in a national multi-institutional registry of penile prostheses procedures (INSIST-ED) from 2014 to 20121. Patient baseline characteristics and postoperative complications were recorded. The primary endpoint of this study was unfavorable outcomes after inflatable PPI, defined as significant postoperative complications (Clavien–Dindo ≥2) and/or Sexuality with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) scores below the 10th percentile. A total of 256 patients were included in the study. The median age was 60 years (IQR 56–67). The most common cause of erectile dysfunction (ED) was organic (42.2%), followed by pelvic surgery/radiotherapy (39.8%) and Peyronie’s disease (18.0%). Postoperative complications were recorded in 9.6%. High-grade complications (Clavien ≥2) occurred in 4.7%. At 1-year follow-up, the median QoLSPP total score was 71 (IQR 65–76). In all, 14.8% of patients were classified as having experienced unfavorable outcomes because of significant postoperative complications and/or QoLSPP scores below the 10th percentile. Logistic regression analysis demonstrated patient age to be non-linearly associated with the risk of experiencing unfavorable outcomes. A U-shaped correlation showed a lower risk for younger and older patients and a higher risk for middle-aged men. ED etiology and surgical volume were not associated with PPI outcomes. Physicians should, therefore, be aware that middle-aged men may be at higher risk of being unsatisfied following PPI compared to both younger and older patients.
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Data availability
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Conceptualization, methodology, software: EP, FD, PG, AP, MF, Mirko Preto. Data curation: NS, CB, FC, SF, AV, MS, NM, Matteo Paradiso, CC, FV, FP, AA, Gabriele Antonini, AC, DP, GF, MB, FB, Enrico Conti, Enrico Caraceni, CN, MC, PV, NG, Giovanni Alei, EI, MT, Massimo Polito, AN, AT, EP. Writing, original draft preparation: Mirko Preto, PC, NP, MF. Visualization, investigation: CB, FC, NM, FP, EC, EP, FD, AP, PC, MP. Supervision: AP, PG, FD, BG. Writing, reviewing and editing: Mirko Preto, PC, NP, MF, BG.
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The study was performed in accordance with the Declaration of Helsinki and was approved by the local ethics committee of IRCSS Ospedale San Raffaele (OSR – 140/2021). A written informed consent was obtained from all subjects enrolled in the present study.
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Preto, M., Falcone, M., Plamadeala, N. et al. Risk of unfavorable outcomes after penile prosthesis implantation – results from a national registry (INSIST-ED). Int J Impot Res (2023). https://doi.org/10.1038/s41443-023-00784-4
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DOI: https://doi.org/10.1038/s41443-023-00784-4
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