BJU Int. 2014 Apr;113(4):615-22. doi: 10.1111/bju.12540.
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.
Men aged ≥ 50 years with an International Prostate Symptom Score of ≥ 13, a maximum urinary flow rate (Qmax) of ≤ 12 mL/s, and a prostate of 30-80 mL 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® (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.
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.
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.
通过交叉设计研究评估“前列腺尿道提升术”（PUL）治疗与良性前列腺增生（BPH）相关下尿路症状（LUTS）的临床疗效。
在完成一项前瞻性、随机、对照、“盲法”的主要研究后，年龄≥50 岁、国际前列腺症状评分（IPSS）≥13、最大尿流率（Qmax）≤12ml/s、前列腺体积为 30-80ml 的男性患者被纳入交叉研究，他们是接受假手术的对照受试者。患者在交叉 PUL 后在美国、加拿大和澳大利亚的 19 个中心接受了 1 年的随访。假手术涉及刚性膀胱镜检查和模拟主动治疗声音。PUL 涉及将永久性 UroLift®（NeoTract，Inc.，加利福尼亚州普莱森顿）植入物放置到前列腺的侧叶以扩大尿道管腔。使用配对统计分析评估和比较假手术和 PUL 之间的尿症状缓解、健康相关生活质量（HRQL）影响、尿流参数、性功能和不良事件。
症状、流量、HRQL 和性功能评估显示，与其他已发表的研究结果相似，与基线结果相比，有改善，并且大多数参数在 PUL 后与假手术相比明显改善。在研究的 12 个月中，症状、流量和 HRQL 的改善是持久的。与该程序相关的不良事件通常是短暂的，轻度至中度；1 名患者（2%）在第一年需要经尿道前列腺切除术的再次干预。没有新出现的、持续的射精或勃起功能障碍。
PUL 可以在局部麻醉下进行，引起的围手术期并发症最小，允许患者快速恢复正常活动，迅速持久地改善症状，并保留性功能。
