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Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones (SPT-CYSTO Tria)

2026年6月15日 更新者：Hany Fathy Badawy, MD、Beni-Suef University

Transurethral Cystolithotripsy With Versus Without Adjunctive Suprapubic Tube Drainage for Bladder Stones >2 cm: A Prospective Randomized Controlled Trial

Bladder stones larger than 2 cm are commonly treated by endoscopic fragmentation through the urethra. During transurethral cystolithotripsy for large stones, the procedure may be prolonged because of poor visibility, stone dust, bladder overdistension, and repeated need for irrigation or evacuation.

This randomized controlled trial will compare standal Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with the same procedure plus an adjunctive 8 Fr suprapubic catheter used only for bladder drainage during the operation. The suprapubic catheter will not be used for stone fragmentation or stone extraction.

The main outcome will be total operative time. Secondary outcomes will include fragmentation and clearance time, laser activation time, total laser energy, irrigation volume, visibility-related interruptions, stone-free rate at 30 days, complications, catheter duration, postoperative pain, and hospital stay.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a prospective, randomized, controlled, parallel-group clinical trial conducted at the Department of Urology, Beni-Suef University Hospital, Faculty of Medicine, Beni-Suef University, Egypt. Adult patients with radiologically confirmed bladder stones greater than 2 cm who are scheduled for elective transurethral cystolithotripsy will be enrolled after written informed consent.

Participants will be randomized in a 1:1 ratio into two groups. The control group will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only. The experimental group will undergo the same procedure with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization. The suprapubic catheter will be connected to free drainage during lithotripsy to assist bladder decompression and irrigation outflow. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.

All procedures will use the same standardized cystoscopic access, Holmium:YAG laser platform, irrigation system, and transurethral evacuation method. The primary outcome is total operative time, measured from cystoscope insertion into the urethra until endoscopic confirmation of complete stone clearance and completion of final urethral catheter placement. Postoperative follow-up will continue for 30 days, including assessment of stone-free status by imaging and recording of perioperative complications.

研究类型

介入性

注册 (估计的)

140

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

学习地点

  • 埃及
    • Beni Suweif Governorate
      • Banī Suwayf、Beni Suweif Governorate、埃及
        • 招聘中
        • Department of Urology- Beni-Suef University Hospitals
        • 首席研究员：
          • Hany F Badawy, MD
        • 接触：
        • 接触：

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:

  • Age 18 years or older.
  • Radiologically confirmed bladder stone with maximum diameter greater than 2 cm.
  • Scheduled for elective transurethral cystolithotripsy.
  • Sterile urine culture before surgery, or adequately treated urinary tract infection according to culture sensitivity.
  • Fit for spinal or general anesthesia.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Urethral stricture preventing safe cystoscopic access.
  • Active uncontrolled urinary tract infection or sepsis.
  • Neurogenic bladder with severely impaired bladder emptying requiring chronic catheterization.
  • History of bladder cancer or suspected bladder tumor requiring simultaneous transurethral resection of bladder tumor.
  • Coagulopathy or uncorrected bleeding tendency.
  • Patients requiring concomitant transurethral resection of the prostate, Holmium laser enucleation of the prostate, or other prostate surgery in the same session.
  • Previous pelvic radiotherapy or major lower urinary tract reconstruction.
  • Pregnancy.
  • Refusal to participate.

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：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard Transurethral Cystolithotripsy
Participants assigned to this arm will undergo standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath with conventional irrigation and transurethral evacuation only, without adjunctive suprapubic catheter drainage.
程序：Standard Transurethral Holmium Laser Cystolithotripsy
Standardized transurethral Holmium:YAG laser cystolithotripsy performed through a 17 Fr cystoscope sheath, with conventional irrigation and transurethral evacuation of stone dust and fragments. A urethral Foley catheter will be inserted at the end of the procedure. This procedure will be performed in both study arms.
实验性的：Transurethral Cystolithotripsy With Suprapubic Drainage
Participants assigned to this arm will undergo the same standardized transurethral Holmium:YAG laser cystolithotripsy using a 17 Fr cystoscope sheath, with adjunctive 8 Fr suprapubic catheter drainage inserted under ultrasound guidance and cystoscopic visualization for bladder drainage and decompression during lithotripsy. No stone fragmentation or extraction will be performed through the suprapubic route
程序：Adjunctive Suprapubic Catheter Drainage
Insertion of an 8 Fr suprapubic catheter under ultrasound guidance and cystoscopic visualization during transurethral cystolithotripsy. The catheter will be connected to free drainage to assist bladder decompression and irrigation outflow during lithotripsy. It will not be used for stone fragmentation, stone extraction, tract dilation, sheath placement, or percutaneous cystolithotripsy.

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
Total Operative Time
大体时间：During the surgical procedure
Total operative time will be measured in minutes from insertion of the cystoscope into the urethra until endoscopic confirmation of complete bladder stone clearance and completion of final urethral catheter placement. In the suprapubic drainage group, the time required for insertion of the 8 Fr suprapubic catheter will be included because the study evaluates the overall procedural efficiency of adding adjunctive suprapubic cathe+ drainage
During the surgical procedure

次要结果测量

结果测量
措施说明
大体时间
Stone Fragmentation and Clearance Time
大体时间：During the surgical procedure
Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance
During the surgical procedure
Total Laser Energy
大体时间：During the surgical procedure
Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.
During the surgical procedure
Visibility-Related Interruptions
大体时间：During the surgical procedure
Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment.
During the surgical procedure
Urethral Catheter Duration
大体时间：From end of surgery until catheter removal, up to 30 days
Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal.
From end of surgery until catheter removal, up to 30 days
Postoperative Pain Score
大体时间：6 hours and 24 hours after surgery
Postoperative pain will be assessed using the Visual Analogue Scale. The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
6 hours and 24 hours after surgery

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。

赞助

Beni-Suef University

调查人员

  • 首席研究员：Hany F Badawy, MD、Faculty of Medicine, Beni-Suef University hospital

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)

2026年6月8日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月11日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FMBSUREC-07062026a-Badawy

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared because the study contains individual-level clinical and operative data. Only aggregated, de-identified study results will be reported in publications or presentations. Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.

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

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.

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