Colombo Fulvio, Gentile Giorgio, Vagnoni Valerio, Fiorillo Alessandro, Piazza Pietro, Sartorio Fabrizio, Franceschelli Alessandro
Andrology Unit, University Hospital S. Orsola-Malpighi, Bologna, Italy.
Department of Urology, University of Bologna, Bologna, Italy.
Asian J Urol. 2021 Apr;8(2):176-182. doi: 10.1016/j.ajur.2020.02.002. Epub 2020 Feb 10.
To evaluate surgical outcomes after implantation of the Zephyr ZSI 475 inflatable penile prosthesis (IPP) and patients' quality of life.
From 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.
The 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.
In 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.
评估Zephyr ZSI 475可膨胀阴茎假体（IPP）植入后的手术效果及患者生活质量。
2014年12月至2018年9月，15例患者接受了ZSI 475假体植入术。对临床资料进行回顾性分析。采用阴茎假体生活质量与性功能问卷（QoLSPP）对患者植入后的生活质量进行调查。
患者中位年龄为57岁，平均随访时间为22个月。12例患者因严重勃起功能障碍（ED）接受标准植入术；3例患者还存在阴茎弯曲，需要额外进行带移植的阴茎成形术。3例手术因插入工具缺陷而中断。1例因制造缺陷导致泵泄漏。1例发生严重术后并发症，需要对该装置进行说明。随访期间，4例患者出现假体机械故障。12个月时QoLSPP问卷结果在所有领域均偏向量表的积极端。
根据我们的初步经验，ZSI 475机械故障率较高；另一方面，该公司为提高该装置的质量和可靠性表现出了极大的诚意。ZSI 475较低的成本可能会增加该产品成为治疗需要IPP的患者的性价比高的替代方案的机会。
