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Initial experience of a single center with the use of ZSI 475 penile prosthesis

机译:使用ZSI 475阴茎假体使用单一中心的初始经验

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ObjectiveTo evaluate surgical outcomes after implantation of the Zephyr ZSI 475 inflatable penile prosthesis (IPP) and patients' quality of life.MethodsFrom December 2014 to September 2018, 15 patients underwent prosthesis implantation with ZSI 475. A retrospective review of clinical data was performed. Patients' quality of life after implantation was investigated with Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) questionnaire.ResultsThe median age of patients was 57 years and the average follow-up time was 22 months. Twelve patients received a standard implantation due to severe erectile dysfunction (ED); three patients also presented penile curvature and additional corporoplasty with grafting was necessary. Three procedures had to be interrupted due to defects of the insertion tools. In one case a manufacturing defect resulted in a pump leak. In one case, a severe postoperative complication occurred, which requested explanation of the device. During the follow-up, four patients experienced mechanical failure of the prosthesis. Results of QoLSPP questionnaire at 12 months were skewed toward the positive end of the scale in all domains.ConclusionIn our initial experience, ZSI 475 suffered a high rate of mechanical failures; on the other hand, the company showed great commitment in order to improve the quality and reliability of the device. The lower cost of ZSI 475 may add to the chances of the product to become a cost-effective alternative to treat those patient who need a IPP.
机译:ObjectiveTO在植入Zephyr ZSI 475充气阴茎假体(IPP)和患者的生活质量后评估手术结果。从2014年12月到2018年12月,15名患者接受了ZSI 475的假体植入。进行了对临床数据的回顾性审查。患者的生活质量植入后植入后,用阴茎假体(QOLSPP)问卷调查。患者中位年龄为57岁,平均随访时间为22个月。由于严重的勃起功能障碍(ED),12名患者接受了标准植入;三名患者还呈现了阴茎曲率和额外的物质术,需要嫁接。由于插入工具的缺陷,必须中断三个程序。在一种情况下,制造缺陷导致泵泄漏。在一种情况下,发生了严重的术后并发症,这需要解释该设备。在随访期间,四名患者经历了假体的机械失效。 12个月的QoLSPP问卷结果偏向于所有域中的规模的正面偏差。结论我们的初步经验,ZSI 475遭受了高机械故障率;另一方面,该公司表现出巨大的承诺,以提高设备的质量和可靠性。 ZSI 475的较低成本可能会增加产品的机会,以成为治疗需要IPP的患者的经济有效的替代方案。

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