Abstract
Erectile dysfunction is a prevalent condition that may impact psychosocial health and quality of life. While various treatment modalities exist, penile prosthesis implantation offers a permanent solution. Surgery, however, carries inherent risks and potential complications. The aim of this study was to determine the incidence and risk factors of early postoperative complications after penile prosthesis surgery in a large, multicenter, prospective, cohort study. Data was analyzed from patients participating in the PHOENIX registry, an international study on penile prosthesis surgery conducted by the EAU Research Foundation. Patients were operated on from November 2021 until august 2024 in 30 centers from 8 countries. Our study was not limited to one device or brand, all available inflatable and malleable devices were eligible for inclusion. Postoperative complications were registered at different time points, up to 2 years post-surgery. For this analysis we studied complications that occurred within 2 weeks after surgery. Data on early complications after penile prosthesis surgery of 1072 patients were analyzed. Median age was 62 (range 24–88) years old at time of surgery. A total of 639 (59.6%) patients received a drain perioperatively. A total of 49 patients (4.6%) reported complications within 2 weeks after surgery. Infection occurred in 4 patients and penoscrotal hematoma occurred in 6 patients within 2 weeks post-surgery. A total of 5 patients underwent early revision surgery. There was no significant effect of diabetes mellitus on development of an early postoperative infection (0.4% vs. 0.4%, p = 1.00). We found no significant impact of drain placement on hematoma development (0.3% vs. 0.3%, p = 0.69). We did find that early hematoma occurred more frequently in low-volume versus high-volume centers (1.3% vs. 0.1%, p = 0.02). This large international study confirms that penile prosthesis surgery is a safe procedure with a low rate of early postoperative complications.
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Data availability
The data that support the findings of this study are available from the EAU Research Foundation. Restrictions apply to the availability of these data, which were used under license for this study. Data are available through the corresponding author upon reasonable request, with the permission of the EAU Research Foundation.
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Funding
Funded by Boston Scientific Corporation United States and Coloplast A/S Denmark.
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KVR: Conceptualization, methodology, supervision, writing – review & editing. HDB: Data curation, formal analysis, methodology, writing – original draft. AY, RC: Conceptualization, writing – original draft. FD, JT, CB, BGG, IM, DR: Conceptualization, supervision, writing – review & editing. MD, CC, WW: Data curation, writing – review & editing.
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Ethical approval was obtained in all participating centers with registration number B24320194051.
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Van Renterghem, K., De Bruyn, H., Yebes, A. et al. Early complications after penile prosthesis surgery: findings from the PHOENIX multicenter registry. Int J Impot Res (2025). https://doi.org/10.1038/s41443-025-01080-z
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DOI: https://doi.org/10.1038/s41443-025-01080-z