Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy.
Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Milan, Italy; Università Vita-Salute San Raffaele, Milan, Italy.
J Sex Med. 2019 Nov;16(11):1827-1833. doi: 10.1016/j.jsxm.2019.08.001. Epub 2019 Sep 6.
Hydraulic penile prostheses have shown an overall good mechanical reliability up to 10 years after surgery; however, few data have been published on very long-term follow-up.
We looked at long-term (≥15 years) complications, including functional and quality of life (QoL) outcomes, after 3-piece inflatable penile prosthesis (IPP) implantation in patients with erectile dysfunction (ED).
Data regarding 149 patients submitting to IPP placement before 2001 were analyzed. All patients were implanted with AMS CX and Ultrex Plus 3-piece prostheses.
Patients were reassessed to evaluate rates of complications and functional outcomes. The validated questionnaire Quality of Life and Sexuality with Penile Prosthesis (QoLSPP) was used to assess patient QoL. Kaplan-Meier analysis estimated the probability of prosthesis survival (defined as working device/not-explanted).
Median follow-up of 51 patients was 206 months (interquartile range [IQR], 145-257). The etiology of ED was vasculogenic (n = 20; 39%), Peyronie's disease (n = 15; 29%), pelvic surgery (n = 4; 7.8%), organic other than vasculogenic (n = 3; 5.9%), or other (n = 9; 18%). Throughout the follow-up, 24 patients (49%) experienced complications: mechanical failure (n = 19; 79%), pain (n = 3; 12%), orgasmic dysfunctions (n = 1; 4.5%), or device infection (n = 1; 4.5%). The estimated IPP survival was 53% (95% CI, 36-67) at 20-year follow-up. Baseline characteristics (age, Charlson comorbidity index, body mass index, and erectile dysfunction etiology) were not significantly associated with the risk of IPP failure over time by Cox regression analysis. At 20-year follow-up, 41% (95% CI, 19-49) of the patients were still using the device. Among them, QoLSPP median domain scores were high: functional 22/25 (IQR, 20-23), relational 17/20 (IQR, 15-18), personal 14/15 (IQR, 12-15), and social 14/15 (IQR, 11-15).
The longevity of the device and long-term satisfaction rates should be comprehensively discussed during patient consultation for IPP surgery.
STRENGTHS & LIMITATIONS: To our knowledge, this is the first study reporting long-term QoL outcomes using a dedicated questionnaire for penile prostheses. The low response rate for the telephone interviews, the retrospective design of the study, and the relatively small number of patients are the main limitations.
Long-term follow-up data after IPP placement showed that almost half of the devices still worked properly 20 years after the original penile implant, as 60% of patients were still using the device with high satisfaction and adequate QoL outcomes. Both patients and physicians should be aware of the expected life and outcomes of IPP implants. Chierigo F, Capogrosso P, Dehò, et al. Long-Term Follow-Up After Penile Prosthesis Implantation-Survival and Quality of Life Outcomes. J Sex Med 2019;16:1827-1833.
阴茎假体在手术后 10 年内具有良好的机械可靠性；然而，很少有数据发表关于非常长期的随访结果。
我们研究了勃起功能障碍（ED）患者在接受三件式可膨胀阴茎假体（IPP）植入后≥15 年的长期（≥15 年）并发症，包括功能和生活质量（QoL）结果。
分析了 2001 年前接受 IPP 植入的 149 名患者的数据。所有患者均植入了 AMS CX 和 Ultrex Plus 三件式假体。
对患者进行重新评估，以评估并发症发生率和功能结果。使用经过验证的阴茎假体生活质量和性生活问卷（QoLSPP）评估患者的 QoL。Kaplan-Meier 分析估计了假体的存活率（定义为工作装置/未植入）。
51 名患者的中位随访时间为 206 个月（四分位距[IQR]，145-257）。ED 的病因是血管性（n=20；39%）、佩罗尼氏病（n=15；29%）、盆腔手术（n=4；7.8%）、非血管性器质性病变（n=3；5.9%）或其他（n=9；18%）。在整个随访期间，24 名患者（49%）经历了并发症：机械故障（n=19；79%）、疼痛（n=3；12%）、性高潮功能障碍（n=1；4.5%）或设备感染（n=1；4.5%）。20 年随访时，IPP 存活率估计为 53%（95%CI，36-67）。Cox 回归分析显示，基线特征（年龄、Charlson 合并症指数、体重指数和 ED 病因）与 IPP 失败风险在时间上无显著相关性。20 年随访时，41%（95%CI，19-49）的患者仍在使用该设备。其中，QoLSPP 中位域评分较高：功能 22/25（IQR，20-23）、关系 17/20（IQR，15-18）、个人 14/15（IQR，12-15）和社会 14/15（IQR，11-15）。
在与患者讨论 IPP 手术时，应综合讨论设备的使用寿命和长期满意度。
据我们所知，这是第一项使用专门的阴茎假体问卷报告长期 QoL 结果的研究。电话访谈的低应答率、研究的回顾性设计以及患者数量相对较少是主要的局限性。
IPP 放置后的长期随访数据显示，20 年前植入的设备中有近一半在 20 年后仍能正常工作，因为 60%的患者仍在使用满意度高且 QoL 结果充足的设备。患者和医生都应该意识到 IPP 植入物的预期寿命和结果。Chierigo F、Capogrosso P、Dehò 等人。阴茎假体植入后长期随访-存活和生活质量结果。J Sex Med 2019；16：1827-1833。
