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Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.

2026年5月5日 更新者:Ahmed Mohammed Attia、Benha University

Comparative Outcomes of Rezūm (Water Vapor Therapy) Versus EchoLaser (Transperineal Laser Ablation) for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe. A Prospective Randomized Comparative Study.

This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.

研究概览

详细说明

This is a single-center, prospective, randomized, active-controlled trial aiming to compare the clinical efficacy, safety profile, and functional outcomes of Rezūm water vapor thermal therapy versus EchoLaser transperineal laser ablation (TPLA). The trial focuses on symptomatic benign prostatic hyperplasia patients with a prostate volume between 30 mL and 80 mL and a confirmed enlarged intravesical median lobe. Eighty eligible male patients will be randomized 1:1 into two interventional groups: Group 1 (Rezūm Group): 40 patients will receive transurethral water vapor thermal therapy. The procedure involves targeted 9-second steam injections into the transition zone, alongside mandatory injections directed explicitly into the intravesical protruding median lobe to induce coagulative necrosis. Group 2 (EchoLaser TPLA Group): 40 patients will receive Transperineal Laser Ablation. Under real-time transrectal ultrasound (TRUS) guidance, optical fibers will deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe. Patients will undergo clinical, functional, and safety assessments at 1, 3, and 6 months post-operatively. Follow-up evaluations include uroflowmetry (peak urinary flow rate and post-void residual volume), symptom assessment via IPSS, and sexual health evaluation using IIEF-5 and MSHQ-EjD questionnaires. Morphological changes, specifically the reduction in Total Prostate Volume (TPV) and median lobe volume, will be confirmed using TRUS or mpMRI at the 6-month follow-up. Postoperative complications will be monitored and systematically graded using the Clavien-Dindo classification system.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

Inclusion Criteria:

Male patients aged 50 years or older.

Diagnosis of symptomatic BPH with moderate-to-severe lower urinary tract symptoms, defined as an IPSS ≥ 12.

Total prostate volume between 30 mL and 80 mL, confirmed via Transrectal Ultrasound (TRUS) or mpMRI.

Presence of an enlarged, obstructing intravesical median lobe visualized via imaging or baseline cystoscopy.

Peak urinary flow rate (Qmax) between 5 and 15 mL/s with a minimum voided volume of ≥ 125 mL.

Exclusion Criteria:

Confirmed or suspected prostate cancer (e.g., PSA > 4.0 ng/mL without a subsequent negative prostate biopsy or MRI).

History of prior surgical interventions for BPH (e.g., TURP, HOLEP, or other MISTs).

Presence of urethral strictures, bladder neck contracture, or established neurogenic bladder dysfunction.

Active urinary tract infection (UTI) or an episode of acute urinary retention requiring an indwelling catheter at the time of screening.

Previous pelvic radiation therapy or severe pelvic trauma.

Inability to safely pause anticoagulant/antiplatelet therapy per standard hospital perioperative protocols, if applicable.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Rezūm Group
40 patients receiving transurethral water vapor thermal therapy (Rezūm). The procedure involves targeted 9-second steam injections into the transition zone and the median lobe.
Conducted via a transurethral approach. Standard 9-second thermal water vapor injections will be delivered into the transition zone, alongside mandatory, specifically angled injections directed explicitly into the intravesical protruding median lobe to induce targeted coagulative necrosis.
有源比较器:EchoLaser TPLA Group
40 patients receiving Transperineal Laser Ablation utilizing the EchoLaser system. Optical fibers will deliver localized diode laser energy to the adenoma and the intravesical median lobe.
Conducted via a transperineal approach. Under real-time transrectal ultrasound (TRUS) guidance, 21G introducer needles are placed, and optical fibers (300 µm) deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in International Prostate Symptom Score (IPSS)
大体时间:Baseline to 6 months
The absolute and percentage difference in total IPSS, reflecting the primary subjective alleviation of lower urinary tract symptoms (LUTS).
Baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Change in Peak Urinary Flow Rate (Qmax)
大体时间:Baseline, 1 month, 3 months, and 6 months
Objective change in peak urinary flow rate, measured in mL/s using uroflowmetry.
Baseline, 1 month, 3 months, and 6 months
Change in Post-Void Residual Volume (PVR)
大体时间:Baseline, 1 month, 3 months, and 6 months
Objective change in post-void residual volume, measured in mL via abdominal ultrasound.
Baseline, 1 month, 3 months, and 6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月1日

初级完成 (估计的)

2026年12月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年5月5日

首先提交符合 QC 标准的

2026年5月5日

首次发布 (实际的)

2026年5月11日

研究记录更新

最后更新发布 (实际的)

2026年5月11日

上次提交的符合 QC 标准的更新

2026年5月5日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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