前列腺尿道L.I.F.T.前瞻性随机对照研究的五年结果。

Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study.

作者信息

Roehrborn Claus G, Barkin Jack, Gange Steven N, Shore Neal D, Giddens Jonathan L, Bolton Damien M, Cowan Barrett E, Cantwell Anthony L, McVary Kevin T, Te Alexis E, Gholami Shahram S, Moseley William G, Chin Peter T, Dowling William T, Freedman Sheldon J, Incze Peter F, Coffield K Scott, Herron Sean, Rashid Prem, Rukstalis Daniel B

机构信息

University of Texas Southwestern Medical Center, Dallas, Texas, USA.

出版信息

Can J Urol. 2017 Jun;24(3):8802-8813.

PMID:28646935

Abstract

INTRODUCTION

To report the five year results of a prospective, multi-center, randomized, blinded sham control trial of the Prostatic Urethral Lift (PUL) in men with bothersome lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH).

MATERIALS AND METHODS

At 19 centers in North America and Australia, 206 subjects ≥ 50 years old with International Prostate Symptom Score (IPSS ) > 12, peak flow rate (Qmax) ≤ 12 mL/s, and prostate volume 30 cc-80 cc were randomized 2:1 to the PUL procedure or blinded sham control. In PUL permanent UroLift implants are placed to hold open the lateral lobes of the prostate to reduce urinary obstruction. After randomized comparison at 3 months and the only opportunity to add more PUL implants, PUL patients were followed to 5 years. LUTS severity (IPSS), quality of life (QOL), BPH Impact Index (BPHII), Qmax, sexual function, and adverse events were assessed throughout follow up.

RESULTS

IPSS improvement after PUL was 88% greater than that of sham at 3 months. LUTS and QOL were significantly improved by 2 weeks with return to preoperative physical activity within 8.6 days. Improvement in IPSS, QOL, BPHII, and Qmax were durable through 5 years with improvements of 36%, 50%, 52%, and 44% respectively. No difference was seen between Intent to Treat and Per Protocol populations. Surgical retreatment was 13.6% over 5 years. Adverse events were mild to moderate and transient. Sexual function was stable over 5 years with no de novo, sustained erectile or ejaculatory dysfunction.

CONCLUSIONS

PUL offers rapid improvement in symptoms, QOL and flow rate that is durable to 5 years. These improvements were achieved with minimal use of a postoperative urinary catheter, rapid return to normal, and preservation of both erectile and ejaculatory function. Symptom improvement was commensurate with patient satisfaction. PUL offers a minimally invasive option in the treatment of LUTS due to BPH.

摘要

引言

报告一项针对因良性前列腺增生（BPH）导致的令人困扰的下尿路症状（LUTS）男性患者的前瞻性、多中心、随机、双盲假对照试验中前列腺尿道悬吊术（PUL）的五年结果。

材料与方法

在北美和澳大利亚的19个中心，将206名年龄≥50岁、国际前列腺症状评分（IPSS）>12、最大尿流率（Qmax）≤12 mL/s且前列腺体积为30 cc - 80 cc的受试者按2:1随机分为接受PUL手术组或双盲假对照组。在PUL手术中，放置永久性UroLift植入物以撑开前列腺侧叶，减轻尿路梗阻。在3个月时进行随机比较，这也是增加更多PUL植入物的唯一机会，之后对PUL组患者进行5年随访。在整个随访过程中评估LUTS严重程度（IPSS）、生活质量（QOL）、BPH影响指数（BPHII）、Qmax、性功能和不良事件。

结果

PUL术后3个月时，IPSS改善程度比假手术组高88%。LUTS和QOL在术后两周时显著改善，术后8.6天即可恢复术前体力活动。IPSS、QOL、BPHII和Qmax的改善在5年内持续存在，改善率分别为36%、50%、52%和44%。意向性治疗人群和符合方案人群之间未见差异。5年内手术再治疗率为13.6%。不良事件为轻至中度且为一过性。性功能在5年内保持稳定，未出现新发的、持续性勃起或射精功能障碍。