A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate
2026年6月3日 更新者：Abdullah Salah Al Debeiky、Tanta University
This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP).
Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL/s) who failed medical therapy will be randomized 1:1:1 into three groups of 30.
Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively.
Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.
研究概览
地位
招聘中
详细说明
Benign prostatic hyperplasia (BPH) is a progressive condition causing lower urinary tract symptoms (LUTS) that significantly impairs quality of life in aging men. While medical therapy with alpha-blockers and 5-alpha reductase inhibitors represents first-line management, surgical intervention becomes necessary when symptoms are severe or complications arise.
Anatomical endoscopic enucleation of the prostate has emerged as the size-independent gold standard surgical approach. This prospective randomized controlled trial will be conducted at the Urology Department, Tanta University Hospital (October 2025 - October 2027) following IRB approval (Code: 36265MD479/10/25).
Patients will undergo preoperative evaluation including IPSS, QoL index, IIEF-5, uroflowmetry, transrectal ultrasound, PSA, CBC, coagulation profile, and renal/liver function tests. Intraoperative data will include total operative time, enucleation time, morcellation time, enucleation efficiency (g/min), and estimated blood loss. Postoperative follow-up at 1, 3, and 6 months will assess IPSS, QoL, IIEF-5, Qmax, and post-void residual. Complications will be graded using the Clavien-Dindo classification. Randomization will use the sealed opaque envelope method with 1:1:1 allocation.
研究类型
介入性
注册 (估计的)
90
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Abdullah Salah Al Debeiky, MD
- 电话号码：+201221430915
- 邮箱：abdullah.aldebeiky@med.tanta.edu.eg
研究联系人备份
- 姓名：Omar Khaled Gad, MSc
- 电话号码：+201117837272
- 邮箱：omar_khaled@med.tanta.edu.eg
学习地点
-
-
Gharbia Governorate
-
Tanta、Gharbia Governorate、埃及、31111
- 招聘中
- Tanta University Hospital
-
接触：
- Abdullah Salah Al Debeiky, MD
- 电话号码：+201221430915
- 邮箱：abdullah.aldebeiky@med.tanta.edu.eg
-
接触：
- Omar Khaled Gad, MSc
- 电话号码：+201117837272
- 邮箱：omar_khaled@med.tanta.edu.eg
-
首席研究员：
- Omar Khaled Gad, MSc
-
副研究员：
- Hassan Hussein El-Tatawy, MD
-
副研究员：
- Mohamed Hassan Radwan, MD
-
副研究员：
- Mohamed Osama Abou Farha, MD
-
副研究员：
- Abdullah Salah Al Debeiky, MD
-
-
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
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Male patients diagnosed with BPH
- Clinical diagnosis of BPH with lower urinary tract symptoms.
- IPSS ≥ 20 (severe symptoms)
- Maximum urinary flow rate (Qmax) ≤ 10 mL/s
- Prostate volume >100 mL (measured by transrectal ultrasound)
- Failed medical therapy and fit for operation
Exclusion Criteria:
- Prostate cancer (current or history).
- Previous prostate surgery
- Previous urethral surgery.
- Neurogenic bladder dysfunction.
- Active urinary tract infection.
- Severe cardiovascular disease (ASA Class IV).
- Previous pelvic radiation.
- Urethral stricture
- Urinary bladder stones.
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：ThuFLEP Group
30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber
|
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber.
Enucleated tissue was removed using a morcellator.
|
|
有源比较器：HoLEP Group
30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber
|
Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber.
Enucleated tissue was removed using a morcellator.
|
|
有源比较器：Bipolar Enucleation Group
30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy
|
Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy.
Enucleated tissue was removed using a morcellator.
|
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 |
|---|---|---|
|
International Prostate Symptom Score (IPSS)
大体时间：at 1, 3 and 6 months post-surgery
|
Change from baseline in IPSS total score (0-35 scale; higher scores indicate worse urinary symptoms).
Scores compared across ThuFLEP, HoLEP, and bipolar enucleation groups.
|
at 1, 3 and 6 months post-surgery
|
|
Quality of Life Score (QoL)
大体时间：Baseline and at 1, 3, and 6 months post-surgery
|
Change from baseline in the IPSS-linked Quality of Life index (0-6 scale; higher scores indicate worse quality of life due to urinary symptoms).
|
Baseline and at 1, 3, and 6 months post-surgery
|
|
Maximum Urinary Flow Rate (Qmax)
大体时间：Baseline and at 1, 3, and 6 months post-surgery
|
Change from baseline in maximum urinary flow rate in mL/s as measured by uroflowmetry.
Higher values indicate better voiding function.
|
Baseline and at 1, 3, and 6 months post-surgery
|
|
Post-Void Residual Urine Volume (PVR)
大体时间：Baseline and at 1, 3, and 6 months post-surgery
|
Change from baseline in post-void residual urine volume in mL as measured by transabdominal ultrasound.
Lower values indicate better bladder emptying.
|
Baseline and at 1, 3, and 6 months post-surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total Operative Time in Minutes
大体时间：Intraoperative
|
Total surgical time from start of procedure to completion, including enucleation and morcellation phases.
|
Intraoperative
|
|
Enucleation Efficiency in Grams per Minute
大体时间：Intraoperative
|
Weight of enucleated prostatic tissue (grams) divided by enucleation time (minutes), reflecting surgical speed and effectiveness.
|
Intraoperative
|
|
Estimated Blood Loss as Change in Hemoglobin Level
大体时间：Baseline and 24 hours postoperatively
|
Difference between preoperative and 24-hour postoperative serum hemoglobin levels (g/dL).
Greater decrease indicates more blood loss.
|
Baseline and 24 hours postoperatively
|
|
Catheterization Duration in Days
大体时间：Up to 7 days postoperatively
|
Number of days from end of surgery until urethral catheter removal, based on resolution of hematuria and clinical assessment.
|
Up to 7 days postoperatively
|
|
Length of Hospital Stay in Days
大体时间：Up to 7 days postoperatively
|
Total number of days from surgery to hospital discharge.
|
Up to 7 days postoperatively
|
|
Number of Participants with Postoperative Complications as Assessed by Clavien-Dindo Classification
大体时间：Up to 6 months postoperatively
|
Rate and severity of complications including urinary incontinence, urinary tract infection, urethral stricture, and need for reoperation, graded using the Clavien-Dindo classification system (Grade I-V; higher grade indicates more severe complication).
|
Up to 6 months postoperatively
|
|
Erectile Function Score (IIEF-5)
大体时间：Baseline and at 1, 3, and 6 months postoperatively
|
Change from baseline in International Index of Erectile Function-5 (IIEF-5) questionnaire score (range 5-25; higher scores indicate better erectile function).
|
Baseline and at 1, 3, and 6 months postoperatively
|
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。
调查人员
- 研究主任：Hassan Hussein El-Tatawy, MD、Tanta University Faculty of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Shoma AM, Ghobrial FK, El-Tabey N, El-Hefnawy AS, El-Kappany HA. A randomized trial of holmium laser vs thulium laser vs bipolar enucleation of large prostate glands. BJU Int. 2023 Dec;132(6):686-695. doi: 10.1111/bju.16174. Epub 2023 Sep 28.
- Giulianelli R, Gentile BC, Mirabile G, Tema G, Nacchia A, Albanesi L, Tariciotti P, Mavilla L, Bellangino M, Lopes Mendes L, Rizzo G, Aloisi P, Vincenti G, Lombardo R. Bipolar Plasma Enucleation of the Prostate: 5 Years Outcomes. J Endourol. 2019 May;33(5):396-399. doi: 10.1089/end.2019.0050.
- Chen YY, Hua WX, Huang YH, Shen XY, You JN, Ding X. The safety and efficacy of five surgical treatments in prostate enucleation: a network meta-analysis. BMC Urol. 2024 Jun 17;24(1):128. doi: 10.1186/s12894-024-01517-5.
- Kosiba M, Filzmayer M, Welte MN, Hugenell L, Keller AC, Traumann MI, Muller MJ, Kluth LA, Mandel PC, Chun FK, Becker A. Thulium fiber laser vs. holmium laser enucleation of the prostate: results of a prospective randomized non-inferiority trial. World J Urol. 2024 Jan 20;42(1):49. doi: 10.1007/s00345-023-04748-7.
- Herrmann TRW, Gravas S, de la Rosette JJ, Wolters M, Anastasiadis AG, Giannakis I. Lasers in Transurethral Enucleation of the Prostate-Do We Really Need Them. J Clin Med. 2020 May 10;9(5):1412. doi: 10.3390/jcm9051412.
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 (实际的)
2025年10月21日
初级完成 (估计的)
2026年11月30日
研究完成 (估计的)
2027年5月30日
研究注册日期
首次提交
2026年5月26日
首先提交符合 QC 标准的
2026年5月29日
首次发布 (实际的)
2026年6月4日
研究记录更新
最后更新发布 (实际的)
2026年6月5日
上次提交的符合 QC 标准的更新
2026年6月3日
最后验证
2025年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 36265MD479/10/25
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data underlying published results will be shared after de-identification, including data for primary and secondary outcome measures.
Data will be available upon reasonable request to the corresponding author following publication.
IPD 共享时间框架
Beginning 6 months after publication of primary results
IPD 共享访问标准
Researchers who provide a methodologically sound proposal approved by the study team.
Requests should be directed to the corresponding author.
Data will be shared for individual participant meta-analyses or systematic reviews.
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
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
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.