Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.
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.
研究概览
地位
条件
详细说明
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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