Wilson Steven K, Wen Lexiaochuan, Carrion Rafael, Eid Francois, Lentz Aaron, Shah Bhavik, Koca Orhan, Hammad Muhammed A M, Gupta Vijayant Govinda, Hamdan Mohammad
Institute for Urologic Excellence, La Quinta, CA, USA.
Department of Urology, Mayo Clinic, Rochester, MN, USA.
Int J Impot Res. 2024 Dec;36(8):833-837. doi: 10.1038/s41443-023-00761-x. Epub 2023 Sep 7.
Implantation of penile prosthesis is considered when conservative measures fail or are unacceptable to patients' wishing treatment for erectile dysfunction. In the United States (US), inflatable penile prostheses are more often used than malleable penile prostheses (MPP). Outside the US, the reverse is true because third-party reimbursement is not available, and MPP is considerably cheaper. Two American manufacturers make MPP; presently, a new manufacturer, Rigicon (Ronkonkoma NY), has recently begun to sell its MPP worldwide. Patient information forms submitted to the manufacturer between March 1, 2019, and December 8, 2022, were used to conduct an initial safety study for 605 first-time patients implanted with Rigicon10® by 46 physicians in 15 countries with a mean follow-up of 21.6 months. It has the same configuration of trimmable, paired silicone rods containing a twisted stainless-steel wire for bendability. However, it is available in six widths with hydrophilic coating compared to three widths offered by competitors. Revision or explantation was needed in 6 of 605 patients (0.99%) with half of those being removed for dissatisfaction (0.50%). Two (0.33%) suffered device infection and one (0.16%) required removal for erosion. Kaplan-Meier's statistical analysis showed three-year implant survival from revision = 99.2%. It demonstrated a comparable safety record with less than 1.00% of patients requiring reoperation.
当保守治疗措施失败或患者不愿接受针对勃起功能障碍的治疗时，可考虑植入阴茎假体。在美国，可膨胀阴茎假体比可弯曲阴茎假体（MPP）更常用。在美国以外的地区情况则相反，因为第三方不提供报销，且MPP价格要便宜得多。美国有两家制造商生产MPP；目前，一家新制造商Rigicon（纽约州罗恩科马）最近开始在全球销售其MPP。使用2019年3月1日至2022年12月8日期间提交给制造商的患者信息表，对15个国家的46名医生为605名首次植入Rigicon10®的患者进行了初步安全性研究，平均随访21.6个月。它具有可修剪的成对硅胶棒的相同配置，其中包含一根用于可弯曲性的扭曲不锈钢丝。然而，与竞争对手提供的三种宽度相比，它有六种宽度且带有亲水涂层。605名患者中有6名（0.99%）需要进行翻修或取出，其中一半因不满意而被取出（0.50%）。两名（0.33%）发生了器械感染，一名（0.16%）因糜烂需要取出。Kaplan-Meier统计分析显示，翻修后的三年植入物存活率为99.2%。它显示出了相当的安全记录，需要再次手术的患者不到1.00%。
