Karaman Muhammet İhsan, Güzel Rasim, Kirkik Duygu, Koca Orhan
Department of Urology, Medistate Kavacık Hospital, İstanbul, Türkiye.
Department of Medical Biology, University of Health Sciences, Hamidiye Medicine Faculty, İstanbul, Türkiye.
Urol Res Pract. 2025 Jan 3;50(4):234-239. doi: 10.5152/tud.2025.24122.
To analyze data from patient information forms (PIFs) submitted to the manufacturer of a new 3-piece inflatable penile prosthesis (IPP), the Rigicon Infla10® , to summarize interim outcomes of 250 implantations in a single center, which is the largest series in Türkiye.
A retrospective review of PIFs from 250 patients implanted with the IPP between January 2021 and December 2023 was performed to assess patient characteristics, surgical data, device durability, patient satisfaction, and rates of reoperation for any reason.
The mean ± SD (range) follow-up was 21.2 ± 8.7 (6-36) months and the mean ± SD patient age was 56.2 ± 9.1 years. The average surgical time was 47 minutes. Of the total, 2.4% of devices required removal or revision. Mechanical failure of the device was reported in 3 patients (1.2%). One patient (0.4%) required revision for noise during pumping. Two patients (0.8%) requested device removal because of dissatisfaction. No infections were observed in this series. A total of 97.6% of the Rigicon Infla10® devices were free from explant or revision. The satisfaction rate based on a single question asked to the patient by the surgeon 6 months after surgery was 98.4%.
All Rigicon Infla10® IPPs implanted in the center prior to January 2024 were included in the retrospective analysis of volunteered PIFs. Initial durability from reoperation was demonstrated to be superior compared to other contemporary devices. Additionally, high satisfaction with treatment outcomes was reported by 92.4% of patients.
分析提交给新型三件式可膨胀阴茎假体（IPP）Rigicon Infla10®制造商的患者信息表（PIF）中的数据，总结在单一中心进行的250例植入手术的中期结果，该中心是土耳其规模最大的系列研究。
对2021年1月至2023年12月期间植入IPP的250例患者的PIF进行回顾性分析，以评估患者特征、手术数据、器械耐用性、患者满意度以及任何原因导致的再次手术率。
平均±标准差（范围）随访时间为21.2±8.7（6 - 36）个月，患者平均年龄为56.2±9.1岁。平均手术时间为47分钟。总共2.4%的器械需要取出或翻修。3例患者（1.2%）报告器械出现机械故障。1例患者（0.4%）因泵血时产生噪音需要翻修。2例患者（0.8%）因不满意要求取出器械。本系列未观察到感染情况。总共97.6%的Rigicon Infla10®器械无需取出或翻修。术后6个月外科医生向患者提出一个问题，基于此的满意率为98.4%。
2024年1月之前在该中心植入的所有Rigicon Infla10® IPP均纳入了自愿提交的PIF的回顾性分析。与其他当代器械相比，再次手术显示出的初始耐用性更佳。此外，92.4%的患者对治疗结果表示高度满意。
