Department of Urology, Centre hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
Pharmaceutical Service, Centre hospitalier Lyon-Sud, Hospices Civils de Lyon, Pierre-Bénite, France.
J Sex Med. 2019 Feb;16(2):316-322. doi: 10.1016/j.jsxm.2018.11.013. Epub 2019 Jan 9.
The ZSI 475FtM is a new prosthesis that has recently been specifically designed for phalloplasty. It has several functions that have been conceived to answer the challenges of implantation after phalloplasty: a large base for pubic bone fixation, realistically shaped hard glans, and a pump shaped like a testicle.
To assess the safety, feasibility, and patient satisfaction of the ZSI 475 FtM.
Surgical outcomes were analyzed after implantation of the prosthesis between June 2016 and September 2017 (single institution, single surgeon). Patients were then asked to answer a satisfaction questionnaire that included the International Index of Erectile Function-5, Erectile Dysfunction Inventory of Treatment Satisfaction, and Self-Esteem and Relationship, as well as other non-validated questions.
Complication rates and the scores of the different questionnaires were reviewed.
20 patients who had gender dysphoria and underwent operation for a female-to-male procedure were included. The mean age was 37.9 years. Complications after 21 implantations included 2 (9.5%) infections that were medically treated (Clavien II), 1 (4.7%) infection treated by explantation (Clavien IIIb), 2 (9.5%) mechanical failures (Clavien IIIb), and 1 (4.7%) malpositioning (Clavien IIIb). The mean follow-up was 8.9 months (SD 4.0), with 50% of the implanted patients having >12 months of follow-up. 14 patients (70%) answered the satisfaction questionnaire. 12 patients (85.7%) had regular penetrative sexual intercourse. The mean International Index of Erectile Function-5 score was 20.2 of 25 (standard deviation [SD] 7.9), the mean Self-Esteem and Relationship score was 84.5 of 100 (SD 9.9), and the mean Erectile Dysfunction Inventory of Treatment Satisfaction score was 82 of 100 (SD 17.5). 13 patients (92.8%) were satisfied or very satisfied with the prosthesis.
This new innovative prosthesis could better answer the challenges faced by the implantation of an erectile device by phalloplasty.
STRENGTH & LIMITATIONS: Our study is the first to report data on this new prosthesis. The main limitation is the small number of patients and the short follow-up.
Preliminary results for the ZSI 475 FtM are encouraging. Safety seems to be satisfactory, and patient satisfaction is high. Long-term studies are needed for further analysis. Neuville P, Morel-Journel N, Cabelguenne D, et al. First Outcomes of the ZSI 475 FtM, a Specific Prosthesis Designed for Phalloplasty. J Sex Med 2019;16:316-322.
ZSI 475FtM 是一种新的假体，最近专门为阴茎成形术而设计。它具有几种功能，旨在应对阴茎成形术后植入的挑战：用于耻骨固定的大型基座、逼真形状的硬质龟头，以及类似睾丸的泵形。
评估 ZSI 475FtM 的安全性、可行性和患者满意度。
2016 年 6 月至 2017 年 9 月（单机构、单外科医生）在植入假体后分析手术结果。然后要求患者回答一份满意度问卷，其中包括国际勃起功能指数-5、治疗满意度勃起功能障碍问卷、自尊和关系，以及其他未经证实的问题。
并发症发生率和不同问卷的评分。
纳入 20 例性别焦虑症患者，行女性到男性手术。平均年龄为 37.9 岁。21 例植入后的并发症包括 2 例（9.5%）经医学治疗的感染（Clavien II 级）、1 例（4.7%）经假体取出治疗的感染（Clavien IIIb 级）、2 例（9.5%）机械故障（Clavien IIIb 级）和 1 例（4.7%）位置不正（Clavien IIIb 级）。平均随访 8.9 个月（SD 4.0），50%的植入患者随访时间超过 12 个月。14 名患者（70%）回答了满意度问卷。12 名患者（85.7%）有规律的穿透性性交。国际勃起功能指数-5 评分平均为 25 分中的 20.2（标准差[SD]7.9），自尊和关系评分平均为 100 分中的 84.5（SD 9.9），治疗满意度勃起功能障碍问卷评分平均为 100 分中的 82（SD 17.5）。13 名患者（92.8%）对假体满意或非常满意。
这种新的创新假体可以更好地应对阴茎成形术植入勃起装置所面临的挑战。
我们的研究首次报告了这种新型假体的数据。主要的限制是患者数量少，随访时间短。
ZSI 475FtM 的初步结果令人鼓舞。安全性似乎令人满意，患者满意度很高。需要进一步分析长期研究。
