Urology Department, University of Texas Southwestern Medical Center, Dallas, TX, 75390, United States.
J Sex Med. 2023 Jun 28;20(7):1044-1051. doi: 10.1093/jsxmed/qdad064.
Despite technical advancements, inflatable penile prostheses (IPPs) are inherently at risk of mechanical failure given their nature as hydraulic devices.
To characterize IPP component failure location at the time of device revision and stratify by manufacturer: American Medical Systems (Boston Scientific [BSCI]) and Coloplast (CP).
A retrospective review of penile prosthesis cases from July 2007 to May 2022 was conducted, identifying men who underwent revision surgery. Cases were excluded if documentation did not denote the cause of failure or the manufacturer. Mechanical indications for surgery were categorized by location (eg, tubing, cylinder, or reservoir leak; pump malfunction). Nonmechanical revisions were excluded (component herniation, erosion, or crossover). Categorical variables were assessed with Fisher exact or chi-square analysis; Student t-test and Mann-Whitney U test were used for continuous variables.
Primary outcomes included specific location of IPP mechanical failure among BSCI and CP devices and time to mechanical failure.
We identified 276 revision procedures, 68 of which met inclusion criteria (46 BSCI and 22 CP). Revised CP devices were longer than BSCI devices (median cylinder length, 20 vs 18 cm; P < .001). Log-rank analysis revealed a similar time to mechanical failure between brands (P = .096). CP devices failed most often due to tubing fracture (19/22, 83%). BSCI devices had no predominant site of failure. Between manufacturers, tubing failure was more common in CP devices (19/22 vs 15/46 for BSCI, P < .001), while cylinder failure was more common among BSCI devices (10/46 vs 0/22 for CP, P = .026).
The distribution of mechanical failure is significantly different between BSCI and CP devices; this has implications regarding the approach to revision surgery.
This is the first study to directly compare when and where mechanical failure occurs in IPPs and to compare the 2 main manufacturers head-to-head. This study would be strengthened by being repeated in a multi-institutional fashion to provide more robust and objective evaluation.
CP devices commonly failed at the tubing and rarely elsewhere, while BSCI devices showed no predominant failure site; these findings may inform decision making regarding revision surgery.
尽管技术不断进步,但由于其作为液压装置的性质,充气阴茎假体(IPP)在本质上存在机械故障的风险。
在设备修订时对 IPP 部件的故障位置进行特征描述,并按制造商进行分层:美国医学系统(波士顿科学公司 [BSCI])和柯惠(CP)。
对 2007 年 7 月至 2022 年 5 月的阴茎假体病例进行回顾性审查,确定接受修订手术的男性。如果文件未注明故障原因或制造商,则排除病例。手术的机械指征按位置分类(例如,管、缸或储液器泄漏;泵故障)。不包括非机械性修订(部件突出、侵蚀或交叉)。使用 Fisher 精确或卡方分析评估分类变量;连续变量使用学生 t 检验和曼-惠特尼 U 检验。
主要结果包括 BSCI 和 CP 装置中 IPP 机械故障的特定位置和机械故障的时间。
CP 装置常见故障发生在管,很少发生在其他部位,而 BSCI 装置没有明显的故障部位;这些发现可能为修订手术的决策提供信息。