随机临床试验比较经尿道前列腺切除术（TURP）与超声激光SORACTELITE-TPLA（经会阴激光消融术）治疗良性前列腺梗阻所致下尿路症状的效果
比较经尿道前列腺切除术（TURP）与经会阴激光消融术（Echolaser Soractelite-TPLA）治疗良性前列腺梗阻所致下尿路症状的随机临床试验
本研究是一项随机临床试验，比较经尿道前列腺切除术（TURP）与回声激光SORACTELITE-TPLA（经会阴激光消融术）在因良性前列腺梗阻导致下尿路症状患者中的效果。
主要目标是通过IPSS评分显示TPLA相对于TURP的非劣效性。
研究概览
研究类型
介入性
注册 (估计的)
80
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：Marcello MZ Zingarelli, medicine and surgery
- 电话号码：+393405135446
- 邮箱：marcellozingarelli86@gmail.com
学习地点
-
-
ITALY/Bari
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Bari、ITALY/Bari、意大利、70124
- 招聘中
- UOC Urologia e Trapianti di Rene Policlinico di Bari
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接触：
- Pasquale PD Ditonno, medicine and surgery
- 电话号码：+390805594390
- 邮箱：pasquale.ditonno@uniba.it
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Bari、ITALY/Bari、意大利、70124
- 主动，不招人
- UOC Urologia e Trapianti di Rene Policlinico di Bari
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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
纳入标准：
- 年龄、下尿路症状（IPSS ≥ 8）、未遵守或未达到IPB药物治疗、前列腺体积40ml-80ml、能够表达知情同意。
排除标准：
- 既往接受过IPB手术治疗、膀胱导管、膀胱结石、泌尿或精液感染、膀胱低/无收缩力、膀胱肿瘤、尿道狭窄、神经性膀胱、拒绝签署知情同意书
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：其他
- 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 |
|---|---|
|
其他：TPLA
患者接受了TPLA治疗
|
经直肠超声引导下经会阴前列腺腺瘤激光消融术
其他名称：
|
|
其他：经尿道前列腺切除术
患者接受了经尿道前列腺电切术治疗
|
经尿道膀胱镜入路前列腺切除术。
|
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 |
|---|---|---|
|
Symptomatology Improvement by International Prostate Symptoms Score (PSS-SCORE)
大体时间：one, three, six, twelve months after treatment
|
After 3,6 and 12 months of follow-up International Prostate Symptom Score (IPSS) questionnaire will be administered to all participants to evaluate changes in subjective symptoms and quality of life (Lower IPSS values indicate an improvement in the symptoms reported by the patient).
The IPSS ranges from 0 to 35, with scores interpreted as follows: 0-7 indicates mild symptoms, 8-19 indicates moderate symptoms, and 20-35 indicates severe symptoms
|
one, three, six, twelve months after treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in the maximum urinary flow rate at Uroflowmetry (Qmax)
大体时间：Differences among preoperative status versus 6, 12 months after treatment
|
Uroflowmetry will be conducted to assess improvements in urinary maximum flow (Qmax: ml/sec).
Differences among preoperative status versus 6, 12 months after treatment
|
Differences among preoperative status versus 6, 12 months after treatment
|
|
Change in Ejaculatory function as assessed by the Male Sexual Health Questionnaire - Ejaculatory function domain (MSHQ-EJD)
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment
|
To assess the impact of the procedures on anterograde ejaculatory function, we will use the Male Sexual Health Questionnaire - Ejaculation Disfunction (MSHQ-EJD).
Higher scores reflect better ejaculatory function, with the questionnaire ranging from 0 to 15.
Additionally, a final question, scored from 0 to 5, assesses the difficulty experienced by the patient during ejaculation.
For this specific question, higher scores correspond to greater levels of difficulty reported (0: no difficulty, 5: extremely bothered).
|
Differences among preoperative status versus 3, 6, 12 months after treatmente, three, six, twelve mounth after treatment
|
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Changes in Post Void Residual (PVR)
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatment
|
Uroflowmetry will be conducted to assess improvements post voided residual (PVR: ml).
Milliliters will be used to report PVR
|
Differences among preoperative status versus 3, 6, 12 months after treatment
|
|
Changes in Sexual Funtion
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatment
|
To assess the impact of the procedures on penile erection, we will use the International Index of Erectile Function (IIEF5) questionnaire. The questionnaire hasn't got units of measurement; they are expressed in absolute numbers. Higher IIEF5 values indicate better erectile function. The IIEF-5 score ranges from 0 to 25. Scores of 22 to 25 indicate normal erectile function, while scores of 17 to 21 suggest mild erectile dysfunction. Scores between 12 and 16 indicate mild-to-moderate dysfunction, 8 to 11 moderate dysfunction, and scores below 7 indicate severe erectile dysfunction |
Differences among preoperative status versus 3, 6, 12 months after treatment
|
|
Change in NIH Chronic Prostatitis Symptom Index (NIH-CPSI) score
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatment
|
Total NIH-CPSI score ranging from 0 to 43, assessing pain, urinary symptoms, and quality of life.
Higher scores indicate worse symptoms.
|
Differences among preoperative status versus 3, 6, 12 months after treatment
|
|
Change in Pelvic Pain and Urgency/Frequency (PUF) score
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatment
|
Pelvic Pain and Urgency/Frequency (PUF) questionnaire score (0-35), higher scores indicate worse symptoms.
|
Differences among preoperative status versus 3, 6, 12 months after treatment
|
|
Prostate Specific Antigen (PSA) value
大体时间：Differences among preoperative status versus 3, 6, 12 months after treatment
|
PSA will be reported by combining nanograms and milliliters (ng/ml).
|
Differences among preoperative status versus 3, 6, 12 months after treatment
|
|
Postoperative complications
大体时间：up to 3 months
|
The Clavien-Dindo classification categorizes complications related to a surgical procedure on a scale from 1 to 5. The severity of the complication increases with higher Clavien-Dindo scores.
|
up to 3 months
|
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Length of hospital stay
大体时间：From hospital admission to discharge at three days (up to three days)
|
Duration of hospitalization measured in days from admission to discharge.
|
From hospital admission to discharge at three days (up to three days)
|
|
Duration of urinary catheterization
大体时间：From catheter insertion to catheter removal at seven days (up to seven days)
|
Time (in days) from placement of the urinary catheter to its removal.
|
From catheter insertion to catheter removal at seven days (up to seven days)
|
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Operative time
大体时间：During the surgical procedure (day 0)
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Duration of the procedure measured in minutes
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During the surgical procedure (day 0)
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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 (实际的)
2024年7月14日
初级完成 (实际的)
2025年12月25日
研究完成 (估计的)
2026年12月25日
研究注册日期
首次提交
2025年12月4日
首先提交符合 QC 标准的
2025年12月4日
首次发布 (实际的)
2025年12月17日
研究记录更新
最后更新发布 (实际的)
2026年9月17日
上次提交的符合 QC 标准的更新
2026年9月14日
最后验证
2025年12月1日
更多信息
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.