Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones (SPT-CYSTO Tria)
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Hany F Badawy, MD
- 電話番号：+201149525028
- メール：HANYFATHY86@GMAIL.COM
研究場所
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Beni Suweif Governorate
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Banī Suwayf、Beni Suweif Governorate、エジプト
- 募集
- Department of Urology- Beni-Suef University Hospitals
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主任研究者：
- Hany F Badawy, MD
-
コンタクト：
- Hany F Badawy, MD
- 電話番号：01149525028
- メール：HANYFATHY86@GMAIL.COM
-
コンタクト：
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：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.
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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.
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実験的：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
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Operative Time
時間枠：During the surgical procedure
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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
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During the surgical procedure
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Stone Fragmentation and Clearance Time
時間枠：During the surgical procedure
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Time measured in minutes from the start of Holmium:YAG laser lithotripsy until endoscopic confirmation of complete bladder stone fragmentation and clearance
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During the surgical procedure
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Total Laser Energy
時間枠：During the surgical procedure
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Total Holmium:YAG laser energy delivered during cystolithotripsy, recorded in joules from the laser device.
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During the surgical procedure
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Visibility-Related Interruptions
時間枠：During the surgical procedure
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Number of intraoperative interruptions of lithotripsy due to poor endoscopic vision, stone dust, bladder overdistension, clot, or need for evacuation or irrigation adjustment.
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During the surgical procedure
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Urethral Catheter Duration
時間枠：From end of surgery until catheter removal, up to 30 days
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Duration of postoperative urethral Foley catheterization, measured from the end of surgery until catheter removal.
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From end of surgery until catheter removal, up to 30 days
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Postoperative Pain Score
時間枠：6 hours and 24 hours after surgery
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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.
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6 hours and 24 hours after surgery
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Hany F Badawy, MD、Faculty of Medicine, Beni-Suef University hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FMBSUREC-07062026a-Badawy
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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