Pisco João Martins, Bilhim Tiago, Costa Nuno V, Torres Daniel, Pisco Joana, Pinheiro Luis Campos, Oliveira Antonio Gouveia
Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal.
Interventional Radiology Unit, Hôpital Saint-Louis, Lisbon, Portugal; Curry Cabral Hospital, Centro Hospitalar Universitário de Lisboa Central (CHULC), Lisbon, Portugal; Radiology Department, NOVA Medical School, Lisbon, Portugal.
Eur Urol. 2020 Mar;77(3):354-362. doi: 10.1016/j.eururo.2019.11.010. Epub 2019 Dec 10.
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.
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.
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.
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.
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.
The improvements in subjective and objective variables after PAE are far superior from those due to the placebo effect.
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.
前列腺动脉栓塞术（PAE）与良性前列腺增生相关下尿路症状（LUTS/BPH）的改善有关，但缺乏随机对照临床试验的确切疗效证据。
评估PAE与假手术治疗LUTS/BPH的安全性和疗效。
设计、场所和参与者：2014年至2019年在一家私人诊所对80名年龄≥45岁、药物治疗无效的重度LUTS/BPH男性患者进行了一项随机、单盲、假手术对照的优效性临床试验，随机分组后6个月和12个月进行疗效评估。PAE组有1例患者，假手术组有3例患者未完成研究。
成功插入前列腺动脉导管后，患者按1:1随机分为PAE组或无栓塞的假PAE手术组。6个月后，所有38例完成单盲期的随机分入假手术组的患者接受了PAE，两组均完成了6个月开放期。
对所有随机分组患者进行意向性分析。共同主要结局是国际前列腺症状评分（IPSS）从基线到6个月的变化以及6个月时的生活质量（QoL）评分，分别采用协方差分析和t检验进行分析。
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。6个月时，PAE组患者的IPSS改善更大，与基线相比变化差值为13.2（95%置信区间[CI]10.2 - 16.2，p<0.0001），6个月时的QoL评分也优于假手术组（差值：2.13；95%CI 1.57 - 2.68，p<0.0001）。假手术组在接受PAE 6个月后的IPSS和QoL改善分别为13.6±9.19（p<0.0001）和2.05±1.71（p<0.0001）。PAE后14例（35.0%）患者发生不良事件，假手术后13例（32.5%）患者发生不良事件，开放期假手术组有1例严重不良事件。未发生治疗失败。局限性包括单中心试验、仅纳入重度LUTS/BPH患者以及随访限于12个月。
PAE后主观和客观变量的改善远优于安慰剂效应所致的改善。
本研究发现前列腺动脉栓塞术（PAE）与假手术相比疗效明显更优，支持PAE用于有典型良性前列腺增生相关症状的患者。
