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Penile prosthesis implantation: a systematic review of intraoperative and postoperative complications

Abstract

Erectile dysfunction (ED) is the most frequently reported male sexual dysfunction. Penile prosthesis implantation (PPI) is an effective solution for patients with medically refractory ED. Despite advancements in surgical techniques and device technology, detailed evidence on PPI complication rates is limited. A systematic review was conducted following PRISMA guidelines, including literature from Medline, Embase, Cochrane Libraries, and clinicaltrial.gov from 2000 to October 2024. Eligible studies included randomized controlled trials (RCTs), non-randomized comparative studies, and case series with ≥5 participants. Adult male patients (≥18 years) undergoing PPI for ED, Peyronie’s disease, or priapism were considered. Eligible interventions included malleable and hydraulic (two- or three-piece) prosthesis implantation, device explantation and reimplantation, and PPI combined with penile curvature correction. Primary outcomes were intraoperative and postoperative complication rates. Of the 1370 studies initially identified, 151 met inclusion criteria, encompassing a total of 92,777 patients. Device infections were reported in 103 studies, with rates ranging from 0.03–14.3%, predominantly under 5%. Erosion rates spanned 0.02–32.5%, with most studies reporting rates below 5%. Mechanical failure rates were highly variable, exceeding 15% in about half the studies with follow-up periods of 5 to 11 years. Intraoperative complications such as urethral injury and corporeal perforation were uncommon but occurred more frequently in patients with severe fibrosis, including those with priapism. Neurological comorbidities were associated with an elevated risk of mechanical failure, while diabetic patients did not exhibit a significantly increased infection risk compared to the general population. Modern techniques and coated devices have reduced infection and erosion rates. However, mechanical failure remains a concern, emphasizing the need for technological advancements. Tailored device selection and comprehensive pre- and postoperative management are critical to reducing revision rates and improving outcomes. Future research should address gaps in surgical approach optimization and complication management.

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Acknowledgements

Marta Pezzoli, for her contribution to this Systematic Review. This Systematic Review was performed under the auspices of the: European Association of Urology Guidelines Office Board; European Association of Urology Sexual & Reproductive Health Guidelines Panel.

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European Association of Urology.

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AC, PC, SM, AS were responsible for designing the review protocol and writing the protocol; AC, PC, SM, AS was responsible for writing the report; AC, PC, SM, CB, LB, JC, AK, JIMS, VM, GIV, ECS were responsible for conducting the search, screening potentially eligible studies, extracting and analysing data, interpreting results. CB, LB, JC, AK, NCC, GH, THJ, UM, JIMS, VM, GIV, ECS, TT, PV contributed to designing the review and provided feedback on the report.

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Correspondence to Andrea Cocci.

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Ege Can Serefoglu is Editor-in-Chief of International Journal of Impotence Research. Luca Boeri, Marco Falcone, and Murat Gul are Associate Editors of International Journal of Impotence Research.

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Cocci, A., Capogrosso, P., Minhas, S. et al. Penile prosthesis implantation: a systematic review of intraoperative and postoperative complications. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01108-4

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