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.
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Hany F Badawy, MD
- Номер телефона: +201149525028
- Электронная почта: HANYFATHY86@GMAIL.COM
Места учебы
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, Египет
- Рекрутинг
- Department of Urology- Beni-Suef University Hospitals
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Главный следователь:
- Hany F Badawy, MD
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Контакт:
- Hany F Badawy, MD
- Номер телефона: 01149525028
- Электронная почта: HANYFATHY86@GMAIL.COM
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Контакт:
- Электронная почта: HANYFATHY86@GMAIL.COM
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Активный компаратор: 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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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Total Operative Time
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Stone Fragmentation and Clearance Time
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Hany F Badawy, MD, Faculty of Medicine, Beni-Suef University hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Мужские мочеполовые заболевания
- Исчисления
- Патологические состояния, анатомические
- Урологические заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Мочекаменная болезнь
- Мочевые камни
- Заболевания мочевого пузыря
- Патологические состояния, признаки и симптомы
- Камни мочевого пузыря
Другие идентификационные номера исследования
- FMBSUREC-07062026a-Badawy
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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