Background

Transurethral resection of the prostate (TURP) is the standard operation for benign prostatic obstruction. Thulium laser transurethral vaporesection of the prostate (ThuVARP) is a technique with suggested advantages over TURP, including reduced complications and hospital stay. We aimed to investigate TURP versus ThuVARP in men with lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction.

Methods

In this randomised, blinded, parallel-group, pragmatic equivalence trial, men in seven UK hospitals with bothersome lower urinary tract symptoms or urinary retention secondary to benign prostatic obstruction were randomly assigned (1:1) at the point of surgery to receive ThuVARP or TURP. Patients were masked until follow-up completion. Centres used their usual TURP procedure (monopolar or bipolar). All trial surgeons underwent training on the ThuVARP technique. Co-primary outcomes were maximum urinary flow rate (Qmax) and International Prostate Symptom Score (IPSS) at 12-months post-surgery. Equivalence was defined as a difference of 2·5 points or less for IPSS and 4 mL per s or less for Qmax. Analysis was done according to the intention-to-treat principle. The trial is registered with the ISRCTN Registry, ISRCTN00788389.

Findings

Between July 23, 2014, and Dec 30, 2016, 410 men were randomly assigned to ThuVARP or TURP, 205 per study group. TURP was superior for Qmax (mean 23·2 mL per s for TURP and 20·2 mL per s for ThuVARP; adjusted difference in means −3·12, 95% CI −5·79 to −0·45). Equivalence was shown for IPSS (mean 6·3 for TURP and 6·4 for ThuVARP; adjusted difference in means 0·28, −0·92 to 1·49). Mean hospital stay was 48 h in both study groups. 91 (45%) of 204 patients in the TURP group and 96 (47%) of 203 patients in the ThuVARP group had at least one complication.

Interpretation

TURP and ThuVARP were equivalent for urinary symptom improvement (IPSS) 12-months post-surgery, and TURP was superior for Qmax. Anticipated laser benefits for ThuVARP of reduced hospital stay and complications were not observed.

Funding

UK National Institute for Health Research Health Technology Assessment Programme.

中文翻译：

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对于下尿路症状或尿retention留的男性，前列腺激光经尿道前列腺汽化术与前列腺经尿道前列腺切除术（UNBLOCS）：一项随机对照试验。

背景

经尿道前列腺电切术（TURP）是良性前列腺阻塞的标准手术。前列腺激光经尿道汽化术（ThuVARP）是一种优于TURP的建议技术，包括减少并发症和住院时间。我们旨在研究下尿路症状或继发于良性前列腺梗阻的尿retention留的男性中TURP与ThuVARP的关系。

方法

在这项随机，双盲，平行，务实的等效试验中，在英国的七家医院中，有下尿路症状困扰或继发于前列腺良性梗阻的尿retention留的男性在手术时被随机分配（1：1）接受ThuVARP或TURP。对患者进行掩蔽直至随访完成。中心使用了他们通常的TURP程序（单极或双极）。所有试验外科医生都接受了有关ThuVARP技术的培训。术后12个月的主要共同结果是最大尿流率（Qmax）和国际前列腺症状评分（IPSS）。当量的定义是：IPSS与Qmax的差为2·5点或更少，而每秒4 mL / s或更少。根据意向治疗原则进行分析。该试验已在ISRCTN注册中心ISRCTN00788389中注册。

发现

在2014年7月23日至2016年12月30日之间，将410名男性随机分配到ThuVARP或TURP中，每个研究组205名。TURP优于Qmax（TURP平均值为23·2 mL / s，ThuVARP平均值为20·2 mL / s；均值之差调节为-3·12、95％CI -5·79至-0·45）。显示了IPSS的等效性（TURP的平均值为6·3，ThuVARP的平均值为6·4；均值的调整差为0·28，-0·92至1·49）。两个研究组的平均住院时间均为48小时。TURP组204例患者中有91例（45％），ThuVARP组203例患者中96例（47％）有至少一种并发症。

解释

TURP和ThuVARP相当于术后12个月的尿道症状改善（IPSS），而TURP优于Qmax。没有观察到预期的激光对ThuVARP有益，可减少住院时间和并发症。

资金

英国国家卫生研究院健康技术评估计划。