BACKGROUND Prostatic artery embolisation (PAE) has been associated with an improvement of lower urinary tract symptoms associated with benign prostatic hyperplasia (LUTS/BPH), but conclusive evidence of efficacy from randomised controlled clinical trials has been lacking. OBJECTIVE To assess the safety and efficacy of PAE compared with a sham procedure in the treatment of LUTS/BPH. DESIGN, SETTING, AND PARTICIPANTS A randomised, single-blind, sham-controlled superiority clinical trial was conducted in 80 males ≥45yr with severe LUTS/BPH refractory to medical treatment from 2014 to 2019 in a private clinic, with efficacy assessments at 6 and 12 mo after randomisation. One patient in the PAE group and three in the sham group did not complete the study. INTERVENTION Patients were randomised 1:1 upon successful catheterisation of a prostatic artery to either PAE or a sham PAE procedure without embolisation. After 6 mo, all 38 patients randomised to the sham group who completed the single-blind period underwent PAE, and both groups completed a 6-mo open period. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS An intention-to-treat analysis of all randomised patients was performed. The coprimary outcomes were the change from baseline to 6 mo in the International Prostate Symptom Score (IPSS) and the quality of life (QoL) score at 6 mo, analysed with analysis of covariance and t test, respectively. RESULTS AND LIMITATIONS Mean age was 63.8±6.0yr, baseline IPSS 26.4±3.87, and QoL score 4.43±0.52. At 6 mo, patients in the PAE arm had a greater improvement in IPSS, with a difference in the change from baseline of 13.2 (95% confidence interval [CI] 10.2-16.2, p<0.0001), and a better QoL score at 6 mo (difference: 2.13; 95% CI 1.57-2.68, p<0.0001) than the patients in the sham arm. The improvements in IPSS and QoL in the sham group 6 mo after they performed PAE were, respectively, 13.6±9.19 (p<0.0001) and 2.05 ± 1.71 (p<0.0001). Adverse events occurred in 14 (35.0%) patients after PAE and in 13 (32.5%) after sham, with one serious adverse event in the sham group during the open period. No treatment failures occurred. Limitations include a single-centre trial, only severe LUTS/BPH, and follow-up limited to 12 mo. CONCLUSIONS The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect. PATIENT SUMMARY Clearly superior efficacy of prostatic artery embolisation (PAE) compared with a sham procedure was found in this study, which supports the use of PAE in patients with typical symptoms associated with benign prostatic hyperplasia.

中文翻译：

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前列腺动脉栓塞的随机临床试验与良性前列腺增生的假手术比较。

背景技术前列腺动脉栓塞术（PAE）与良性前列腺增生症（LUTS / BPH）引起的下尿路症状的改善有关，但尚缺乏确凿的证据来自随机对照临床试验。目的评估PAE与假手术相比在LUTS / BPH治疗中的安全性和有效性。设计，地点和参加者于2014年至2019年在私人诊所对80名≥45岁，重度LUTS / BPH难治的男性进行了一项随机，单盲，假对照的优势临床试验，其疗效评估分别为6岁和6岁。随机分组后12个月。PAE组中的一名患者和假组中的三名患者未完成研究。干预将患者随机分为1组：在成功将前列腺动脉导管插入PAE或假PAE程序而未栓塞时，结果为1。6个月后，所有38位随机分组的假手术患者均完成了单盲期接受PAE，两组均完成了6个月的开放期。结果测量和统计分析对所有随机患者进行意向治疗分析。共同的主要结果是国际前列腺症状评分（IPSS）从基线到6 mo的变化以及6 mo时的生活质量（QoL）评分，分别通过协方差分析和t检验进行了分析。结果与局限性平均年龄为63.8±6.0岁，基线IPSS为26.4±3.87，QoL评分为4.43±0.52。在6个月时，PAE组患者的IPSS改善更大，与基线相比变化为13。2（95％置信区间[CI] 10.2-16.2，p <0.0001），并且在6 mo时的QoL评分（差异：2.13； 95％CI 1.57-2.68，p <0.0001）比假手术组的患者好。假手术组在进行PAE后6 mo的IPSS和QoL改善分别为13.6±9.19（p <0.0001）和2.05±1.71（p <0.0001）。假手术后14例（35.0％）患者发生假事件，假手术后13例（32.5％）发生不良事件，假手术组在开放期间出现严重不良事件。没有发生治疗失败。局限性包括单中心试验，仅严重的LUTS / BPH和随访限制为12 mo。结论PAE后主观和客观变量的改善远优于安慰剂效应。