原装及增强型Mentor Alpha I阴茎假体的机械可靠性比较。

Comparison of mechanical reliability of original and enhanced Mentor Alpha I penile prosthesis.

作者信息

Wilson S K, Cleves M A, Delk J R

机构信息

Southwest Impotence Center, Van Buren, Arkansas, USA.

出版信息

J Urol. 1999 Sep;162(3 Pt 1):715-8. doi: 10.1097/00005392-199909010-00022.

DOI:10.1097/00005392-199909010-00022

PMID:10458350

Abstract

PURPOSE

We report the results of a prospective study of 1,381 Mentor Alpha I penile prostheses implanted to treat impotence, and compare original and enhanced penile prosthesis mechanical reliability.

MATERIALS AND METHODS

The study consisted of 410 original models manufactured before November 1992 and 971 enhanced models manufactured since December 1992. Implants were further stratified as first time (virgin) or replacements of a previous implant. Mechanical failure-free survival rates for the original prosthetic and enhanced models were compared.

RESULTS

The 5-year survival rate increased from 75.3% for the original to 92.6% for the enhanced model overall (log rank p<0.0001), and from 75.3 to 93.6%, respectively, for the virgin implants only (log rank p<0.0001). The estimated failure rate of approximately 5.6% for the original model was fairly consistent during followup, while the significantly lower failure rate of 1.3% for the enhanced model was not. The failure rate of the enhanced model implants was about 0.8% per year during the first 3.5 years and increased to approximately 3.1% per year thereafter.

CONCLUSIONS

Our results strongly support the premise that mechanical reliability is superior with the enhanced compared to the original model.

摘要

目的

我们报告了一项对1381例植入Mentor Alpha I阴茎假体治疗阳痿的前瞻性研究结果，并比较了原始型和改良型阴茎假体的机械可靠性。

材料与方法

该研究包括1992年11月之前生产的410个原始型号和1992年12月之后生产的971个改良型号。植入进一步分为首次（初次）植入或先前植入物的更换。比较了原始假体和改良假体的无机械故障生存率。

结果

总体而言，5年生存率从原始型号的75.3%提高到改良型号的92.6%（对数秩检验p<0.0001），仅初次植入的情况分别从75.3%提高到93.6%（对数秩检验p<0.0001）。原始型号的估计故障率约为5.6%，在随访期间相当稳定，而改良型号显著较低的故障率1.3%则不然。改良型号植入物在前3.5年的故障率约为每年0.8%，此后增加到约每年3.1%。