Goldstein I, Newman L, Baum N, Brooks M, Chaikin L, Goldberg K, McBride A, Krane R J
Department of Urology, Boston University School of Medicine, Massachusetts, USA.
J Urol. 1997 Mar;157(3):833-9.
We investigated safety and efficacy outcome pertaining to the Mentor Alpha-1, 3-piece inflatable penile prosthesis for impotence treatment.
A 2-phase, multi-institutional, large scale retrospective study, with independently analyzed medical record (phase I) and questionnaire (phase II) data from consecutive eligible patients of 7 physician investigators was performed from March to October 1993.
In phase I there were no morbidities of any type in 394 of the 434 patients (90.8%) (mean age 61 years, range 24 to 88) who underwent Alpha-1 implantation (mean followup 22.2 months, range 0.67 to 44.5). The risk of prosthesis malfunction (fluid leak and auto-inflation) was 2.5%. No cylinder aneurysms were reported. A total of 93.1% of Alpha-1 devices was free from explantation (4.4%) or revision surgery (2.5%) for approximately 2 years from the original implant date. Kaplan-Meier actuarial analyses revealed that cumulative survival of the Alpha-1 prostheses at 12, 24 and 36 months was 98 +/- 1%, 93 +/- 2% and 85 +/- 7% until device malfunction, and 91 +/- 2% 83 +/- 4% and 75 +/- 7% until surgical intervention (revision or explantation). In phase II 89% of the men claimed fulfilled expectations with the Alpha-1 prosthesis as impotence treatment. Satisfaction responses 80% or greater were noted with regard to intercourse ability and confidence, and device rigidity and function. Implantation did not result in greater than 80% satisfaction in partner relationships or feelings (as judged by the patient), social or work confidence, or intercourse frequency. Factors adversely affecting satisfaction included partner feelings of dissatisfaction (as judged by the patient), specific physician investigators and need for explantation/revision surgery.
In 1 of the largest multi-institutional implant outcome studies thus far performed, safety and efficacy data concerning the Alpha-1 contemporary inflatable device were found markedly improved over earlier inflatable prostheses and now compare favorably with historical data from noninflatable rod type devices.
我们研究了Mentor Alpha-1三件套可膨胀阴茎假体治疗阳痿的安全性和有效性结果。
1993年3月至10月进行了一项两阶段、多机构的大规模回顾性研究，对7名医生研究者连续纳入的合格患者的病历（第一阶段）和问卷（第二阶段）数据进行独立分析。
在第一阶段，434例接受Alpha-1植入术的患者（平均年龄61岁，范围24至88岁）中，394例（90.8%）未出现任何类型的并发症（平均随访22.2个月，范围0.67至44.5个月）。假体故障（液体渗漏和自动膨胀）的风险为2.5%。未报告圆柱体动脉瘤。从最初植入日期起约2年，共有93.1%的Alpha-1装置未进行取出（4.4%）或翻修手术（2.5%）。Kaplan-Meier精算分析显示，Alpha-1假体在12、24和36个月时的累积生存率，直至装置故障分别为98±1%、93±2%和85±7%，直至手术干预（翻修或取出）分别为91±2%、83±4%和75±7%。在第二阶段，89%的男性声称对Alpha-1假体治疗阳痿达到了预期。在性交能力和信心、装置硬度和功能方面，满意度回答达到或超过80%。植入术在伴侣关系或感受（由患者判断）、社交或工作信心或性交频率方面的满意度未超过80%。影响满意度的不利因素包括伴侣的不满情绪（由患者判断）、特定的医生研究者以及取出/翻修手术的需求。
在迄今为止最大规模的多机构植入结果研究之一中，发现有关Alpha-1当代可膨胀装置的安全性和有效性数据比早期可膨胀假体有显著改善，现在与非可膨胀棒状装置的历史数据相比具有优势。
