Wilson Steven K, Delk John R, Salem Emad A, Cleves Mario A
Department of Urology, University of Arkansas for Medical Sciences, 4301 W. Markham, Little Rock, AR 72205, USA.
J Sex Med. 2007 Jul;4(4 Pt 1):1074-9. doi: 10.1111/j.1743-6109.2007.00540.x.
Long-term revision-free survival, greater than 10 years has never been reported for inflatable penile prostheses. We conducted a historical prospective study to estimate 10 and 15 years survival of first time (virgin) implantations in 2,384 patients with four different models.
Evaluation of 10- and 15-year mechanical and overall revision-free survival of inflatable penile prostheses.
Kaplan-Meier product limit method, and comparison using the log rank test, were used to estimate the 10- and 15-year revision-free survival.
Data were obtained from medical records and patient interviews, entered into a computerized database, and analyzed by a third party. Information included implant type, date, revision history with date, and reason. Fourteen different inflatables were examined. Mentor Alpha 1, Mentor Alpha NB, AMS 700 CX, and AMS 700 Ultrex had usage for an extended period of time. Because of failure times being confounded as a result of prior implants, only virgin implants were examined.
For the entire series, estimated 10-year revision-free survival for all reasons was 68.5% and the 15-year revision-free survival was 59.7%. Freedom from mechanical breakage at 10 years was 79.4%; 15 years was 71.2%. Recent mechanically enhanced models did even better. In 1992, Mentor Alpha added pump reinforcement to forestall mechanical breakage. This improved 10-year survival from 65.3% to 88.6% (P = 0.0001). In January 2001, AMS CX added a parylene coating to the cylinders that increased 3-year mechanical survival from 88.4 to 97.9% (P = 0.0002).
This is the first report on long-term reliability of inflatable penile prostheses. We estimated 60% of these virgin implants would survive 15 or more years without revision or extraction. Newer enhanced models are currently available, and our tracking predicts even better long-term survival for these devices.
可膨胀阴茎假体超过10年的长期无翻修生存率此前从未有过报道。我们进行了一项历史性前瞻性研究，以评估2384例首次（初次）植入四种不同型号假体患者的10年和15年生存率。
评估可膨胀阴茎假体10年和15年的机械性和总体无翻修生存率。
采用Kaplan-Meier乘积限法，并使用对数秩检验进行比较，以估计10年和15年的无翻修生存率。
数据来自病历和患者访谈，录入计算机数据库，并由第三方进行分析。信息包括植入类型、日期、带日期的翻修史以及原因。检查了14种不同的可膨胀假体。Mentor Alpha 1、Mentor Alpha NB、AMS 700 CX和AMS 700 Ultrex使用时间较长。由于先前植入导致失败时间混淆，仅检查了初次植入。
对于整个系列，所有原因导致的估计10年无翻修生存率为68.5%，15年无翻修生存率为59.7%。10年时无机械破损生存率为79.4%；15年时为71.2%。近期机械性能增强的型号表现更好。1992年，Mentor Alpha增加了泵的加固以防止机械破损。这将10年生存率从65.3%提高到了88.6%（P = 0.0001）。2001年1月，AMS CX在圆柱体上添加了聚对二甲苯涂层，使3年机械生存率从88.4%提高到了97.9%（P = 0.0002）。
这是关于可膨胀阴茎假体长期可靠性的首份报告。我们估计这些初次植入的假体中有60%能在15年或更长时间内存活而无需翻修或取出。目前有更新的增强型号，我们的跟踪预测这些装置的长期生存率会更高。
