Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia
Multicentre prospective crossover study of the 'prostatic urethral lift' for the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia
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DOI：
10.1111/bju.12540
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发表时间：
2014-04-01
影响因子：
4.5
通讯作者：
Woo, Henry H.
中科院分区：
文献类型：
--
作者：
Cantwell, Anthony L.;Bogache, William K.;Woo, Henry H.
目的探讨前列腺尿道提升术（PUL）治疗良性前列腺增生（BPH）伴下尿路症状（LUTS）的临床疗效。方法患者年龄50岁，国际前列腺症状评分13分，最大尿流率（Q（max））12 mL/s，和前列腺30- 80 mL的患者在完成前瞻性、随机、对照、盲法关键研究后入组交叉研究，其中他们是接受假手术的对照受试者。在美国、加拿大和澳大利亚的19个中心进行交叉PUL后，对患者进行了1年的随访。假手术包括使用模拟主动治疗声音进行硬性膀胱镜检查。PUL涉及放置永久UroLift（（R））（NeoTract，Inc.，普莱森顿，CA，USA）植入前列腺的侧叶以扩大尿道腔。泌尿系统症状缓解，健康相关的生活质量（HRQL）的影响，尿流参数，性功能，和不良事件进行了评估和比较之间的假和PUL使用配对statistical analysis.Results症状，流量，HRQL和性功能评估显示从基线结果的反应改善，类似于其他已发表的研究结果，在相同患者中，PUL后与假手术相比，大多数参数均显著改善。在12个月的研究中，症状、血流和HRQL的改善是持久的。与手术相关的不良事件通常为一过性和轻度至中度; 1例患者（2%）在第一年需要再次介入经尿道前列腺切除术。有没有发生的从头，持续射精或勃起功能障碍。结论PUL可以在局部麻醉下进行，引起最小的相关围手术期并发症，使患者能够迅速恢复正常活动，提供快速和持久的改善症状，并保留性功能。
Objective To assess the clinical effect of the prostatic urethral lift' (PUL) on lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) through a crossover design study.Patients and Methods Men aged 50 years with an International Prostate Symptom Score of 13, a maximum urinary flow rate (Q(max)) of 12mL/s, and a prostate of 30-80mL were enrolled into a crossover study after completing a prospective, randomised, controlled, blinded' pivotal study in which they were control subjects receiving a sham procedure. Patients were followed for 1 year after crossover PUL at 19 centres in the USA, Canada and Australia. The sham procedure involved rigid cystoscopy with simulated active treatment sounds. PUL involved placing permanent UroLift((R)) (NeoTract, Inc., Pleasanton, CA, USA) implants into the lateral lobes of the prostate to enlarge the urethral lumen. Urinary symptom relief, health-related quality of life (HRQL) impact, urinary flow parameters, sexual function, and adverse events were assessed and compared between the sham and PUL using paired statistical analysis.Results Symptom, flow, HRQL and sexual function assessments showed response improvements from baseline results, similar to results from other published studies, and most parameters were markedly improved after PUL vs the sham procedure in the same patients. Symptom, flow, and HRQL improvements were durable over the 12 months of the study. Adverse events associated with the procedure were typically transient and mild to moderate; one patient (2%) required re-intervention with transurethral resection of the prostate in the first year. There were no occurrences of de novo, sustained ejaculatory or erectile dysfunction.Conclusion The PUL can be performed under local anaesthesia, causes minimal associated perioperative complications, allows patients to quickly return to normal activity, provides rapid and durable improvement in symptoms, and preserves sexual function.