Department of Urology, Ghent University Hospital, Ghent, Belgium.
Department of Urology, Ghent University Hospital, Ghent, Belgium.
J Sex Med. 2021 Mar;18(3):615-622. doi: 10.1016/j.jsxm.2020.11.008. Epub 2021 Jan 19.
Until recently, all available erectile devices were manufactured in accordance with the anatomy of a native penis and led to high explantation rates when implanted in the neophallus.
The aim of this study was to investigate surgical outcomes after implantation of the ZSI 475 FTM in the neophallus; this is the first erectile device specifically manufactured for implantation after phalloplasty.
This is a prospective observational study of patients undergoing implantation of the ZSI 475 FTM in the neophallus at a tertiary referral center since September 2017. Patients with a follow-up < 3 months were excluded from this analysis.
Intraoperative and postoperative complications were analyzed with descriptive statistics and explantation-free survival was assessed using a Kaplan-Meier survival analysis.
In total, 57 patients were included with a median (IQR) follow-up of 16 (10-21) months. No intraoperative complications occurred. Postoperative complications were seen in 18 of 57 (32%) patients and included cylinder protrusion (1/57, 1.8%), infection (8/57, 14%), malpositioning (4/57, 7.0%), mechanical failure (4/57, 7.0%), and urinary retention (1/57, 1.8%). A total of 13 of 57 (23%) devices were explanted which corresponds with an estimated explantation-free survival rate (SD) of 84% (4.9), 80% (5.6), and 80% (5.6) after, respectively, 6, 12, and 18 months of follow-up.
By better addressing the specific needs after phalloplasty, this innovative erectile device might lead to improved cylinder protrusion, malpositioning, and mechanical failure rates, but device infection remains common.
STRENGTHS & LIMITATIONS: This is the largest study on this topic to date and the first to report prospective data. Main limitations involve the relatively small sample size and the limited follow-up.
Short-term cylinder protrusion, malpositioning, and mechanical failure rates are encouraging, although device infection remains a common problem. These complications resulted in a device explantation rate of 23%. Verla W, Goedertier W, Lumen N, et al. Implantation of the ZSI 475 FTM Erectile Device After Phalloplasty: A Prospective Analysis of Surgical Outcomes. J Sex Med 2021;18:615-622.
直到最近，所有可用的勃起装置都是根据原生阴茎的解剖结构制造的，当植入新阴茎时，其导致的高取出率。
本研究旨在探讨 ZSI 475 FTM 勃起装置植入新阴茎后的手术结果；这是第一个专门为阴茎成形术后植入而制造的勃起装置。
这是一项对 2017 年 9 月以来在三级转诊中心接受 ZSI 475 FTM 植入新阴茎的患者进行的前瞻性观察研究。随访<3 个月的患者被排除在本分析之外。
术中及术后并发症采用描述性统计分析，采用 Kaplan-Meier 生存分析评估无取出生存率。
共纳入 57 例患者，中位（IQR）随访 16（10-21）个月。无术中并发症发生。57 例患者中有 18 例（32%）出现术后并发症，包括圆柱体突出（1/57，1.8%）、感染（8/57，14%）、错位（4/57，7.0%）、机械故障（4/57，7.0%）和尿潴留（1/57，1.8%）。57 例中有 13 例（23%）装置被取出，估计无取出生存率（SD）分别为 84%（4.9）、80%（5.6）和 80%（5.6），分别随访 6、12 和 18 个月后。
通过更好地满足阴茎成形术后的特殊需求，这种创新的勃起装置可能会降低圆柱体突出、错位和机械故障的发生率，但装置感染仍然很常见。
这是迄今为止该主题最大的研究，也是第一个报告前瞻性数据的研究。主要限制包括样本量相对较小和随访时间有限。
尽管装置感染仍然是一个常见的问题，但短期的圆柱体突出、错位和机械故障发生率令人鼓舞。这些并发症导致了 23%的装置取出率。Verla W、Goedertier W、Lumen N 等人。阴茎成形术后植入 ZSI 475 FTM 勃起装置：一项手术结果的前瞻性分析。J 性医学 2021;18:615-622.
