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阴茎假体手术后的早期并发症:来自凤凰多中心注册研究的结果。

Early complications after penile prosthesis surgery: findings from the PHOENIX multicenter registry.

作者信息

Van Renterghem Koenraad, De Bruyn Helene, Yebes Alvaro, Calopedos Ross, Deho Federico, Torremadé Jose, D'Anna Maurizio, Bettocchi Carlo, Gomez Borja García, Caris Christien, Witjes Wim, Moncada Ignacio, Ralph David

机构信息

Jessa Hospital, Hasselt, Belgium.

Hasselt University, Hasselt, Belgium.

出版信息

Int J Impot Res. 2025 May 7. doi: 10.1038/s41443-025-01080-z.

DOI:10.1038/s41443-025-01080-z
PMID:40335744
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.

摘要

勃起功能障碍是一种普遍存在的疾病,可能会影响心理社会健康和生活质量。虽然存在各种治疗方式,但阴茎假体植入提供了一种永久性解决方案。然而,手术具有内在风险和潜在并发症。本研究的目的是在一项大型、多中心、前瞻性队列研究中确定阴茎假体手术后早期术后并发症的发生率和危险因素。对参与 PHOENIX 注册研究的数据进行了分析,该研究是由欧洲泌尿外科学会研究基金会开展的一项关于阴茎假体手术的国际研究。患者于 2021 年 11 月至 2024 年 8 月在来自 8 个国家的 30 个中心接受手术。我们的研究不限于一种器械或品牌,所有可用的可膨胀和可弯曲器械均符合纳入标准。术后并发症在不同时间点进行记录,直至术后 2 年。对于本分析,我们研究了手术后 2 周内发生的并发症。对 1072 例患者阴茎假体手术后早期并发症的数据进行了分析。手术时的中位年龄为 62 岁(范围 24 - 88 岁)。共有 639 例(59.6%)患者在围手术期放置了引流管。共有 49 例(4.6%)患者在术后 2 周内报告了并发症。术后 2 周内有 4 例发生感染,6 例发生阴茎阴囊血肿。共有 5 例患者接受了早期翻修手术。糖尿病对术后早期感染的发生没有显著影响(0.4% 对 0.4%,p = 1.00)。我们发现引流管放置对血肿形成没有显著影响(0.3% 对 0.3%,p = 0.69)。我们确实发现,与大容量中心相比,小容量中心早期血肿的发生率更高(1.3% 对 0.1%,p = 0.02)。这项大型国际研究证实,阴茎假体手术是一种安全的手术,术后早期并发症发生率较低。

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本文引用的文献

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Perioperative infection prevention during inflatable penile prosthesis surgery: a narrative review.可膨胀阴茎假体手术围手术期感染的预防:一项叙述性综述
Transl Androl Urol. 2024 Aug 31;13(8):1628-1640. doi: 10.21037/tau-23-497. Epub 2024 Aug 26.
2
Value of prolonged scrotal drainage after penile prosthesis implantation: a multicenter prospective nonrandomized pilot study.阴茎假体植入术后延长阴囊引流的价值:一项多中心前瞻性非随机试点研究。
Int J Impot Res. 2025 Jan;37(1):87-91. doi: 10.1038/s41443-023-00710-8. Epub 2023 May 11.
3
Defining the incidence and management of postoperative scrotal hematoma after primary and complex three-piece inflatable penile prosthesis surgery.
明确初次及复杂三件式可膨胀阴茎假体手术后阴囊血肿的发生率及处理方法。
Int J Impot Res. 2025 Jan;37(1):82-86. doi: 10.1038/s41443-023-00697-2. Epub 2023 May 8.
4
Majority of erectile dysfunction patients would have preferred earlier implantation of their penile prosthesis: validation of the recently changed EAU guidelines.大多数勃起功能障碍患者更倾向于更早植入阴茎假体:对近期更改的欧洲泌尿外科学会指南的验证
Int J Impot Res. 2023 Dec;35(8):731-735. doi: 10.1038/s41443-022-00620-1. Epub 2022 Sep 27.
5
Perspective on the PHOENIX trial: prospective registry for patients undergoing penile prosthesis implantation for male erectile dysfunction in multiple European centers.关于凤凰试验的观点:欧洲多个中心针对男性勃起功能障碍患者进行阴茎假体植入的前瞻性登记研究。
Int J Impot Res. 2023 Jun;35(4):329-331. doi: 10.1038/s41443-022-00547-7. Epub 2022 Feb 26.
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European Association of Urology Guidelines on Sexual and Reproductive Health-2021 Update: Male Sexual Dysfunction.欧洲泌尿外科学会 2021 年性与生殖健康指南更新:男性性功能障碍。
Eur Urol. 2021 Sep;80(3):333-357. doi: 10.1016/j.eururo.2021.06.007. Epub 2021 Jun 26.
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Risk factors associated with penile prosthesis infection: systematic review and meta-analysis.与阴茎假体感染相关的风险因素:系统评价和荟萃分析。
Int J Impot Res. 2020 Nov;32(6):587-597. doi: 10.1038/s41443-020-0232-x. Epub 2020 Feb 3.
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Updates in penile prosthesis infections.阴茎假体感染的最新进展。
Asian J Androl. 2020 Jan-Feb;22(1):28-33. doi: 10.4103/aja.aja_84_19.
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Closed suction drain outputs at 12 and 24 hours after primary three-piece inflatable penile prosthesis surgery.术后 12 小时和 24 小时时,对三件套可膨胀阴茎假体手术进行密闭式吸引引流。
Int J Impot Res. 2020 Jan;32(1):117-121. doi: 10.1038/s41443-019-0130-2. Epub 2019 Mar 18.
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Sex Med Rev. 2019 Jan;7(1):178-188. doi: 10.1016/j.sxmr.2018.10.003. Epub 2018 Nov 30.