[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642198":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":41,"responsibleParty":60,"collaborators":26,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":26,"enrollmentInfo":73,"targetDuration":26,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Transurethral Cystolithotripsy","ACTIVE_COMPARATOR","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.",[13],"Procedure: Standard Transurethral Holmium Laser Cystolithotripsy",{"label":15,"type":16,"description":17,"interventionNames":18},"Transurethral Cystolithotripsy With Suprapubic Drainage","EXPERIMENTAL","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",[19],"Procedure: Adjunctive Suprapubic Catheter Drainage",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.",[15],[32],{"name":33,"affiliation":34,"role":35},"Hany F Badawy, MD","Faculty of Medicine, Beni-Suef University hospital","PRINCIPAL_INVESTIGATOR",[37],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+201149525028","HANYFATHY86@GMAIL.COM",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":26,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Department of Urology- Beni-Suef University Hospitals","RECRUITING","Banī Suwayf","Beni Suweif Governorate","Egypt","EG",{"type":50,"coordinates":51},"Point",[52,53],31.09785,29.07441,{"lat":53,"lon":52},[56,58,59],{"name":33,"role":38,"phone":57,"phoneExt":26,"email":40},"01149525028",{"name":26,"role":38,"phone":26,"phoneExt":26,"email":40},{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Hany Fathy Badawy, MD","Lecturer of Urology, Faculty of Medicine, Beni-Suef University","100642198","suprapubic-drainage-during-transurethral-cystolithotripsy-for-large-bladder-stones-100642198",false,"NCT07642440","Suprapubic Drainage During Transurethral Cystolithotripsy for Large Bladder Stones","Transurethral Cystolithotripsy With Versus Without Adjunctive Suprapubic Tube Drainage for Bladder Stones >2 cm: A Prospective Randomized Controlled Trial","SPT-CYSTO Tria","Inclusion Criteria:\n\n* Age 18 years or older.\n* Radiologically confirmed bladder stone with maximum diameter greater than 2 cm.\n* Scheduled for elective transurethral cystolithotripsy.\n* Sterile urine culture before surgery, or adequately treated urinary tract infection according to culture sensitivity.\n* Fit for spinal or general anesthesia.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Urethral stricture preventing safe cystoscopic access.\n* Active uncontrolled urinary tract infection or sepsis.\n* Neurogenic bladder with severely impaired bladder emptying requiring chronic catheterization.\n* History of bladder cancer or suspected bladder tumor requiring simultaneous transurethral resection of bladder tumor.\n* Coagulopathy or uncorrected bleeding tendency.\n* Patients requiring concomitant transurethral resection of the prostate, Holmium laser enucleation of the prostate, or other prostate surgery in the same session.\n* Previous pelvic radiotherapy or major lower urinary tract reconstruction.\n* Pregnancy.\n* Refusal to participate.","ALL","18 Years",{"count":74,"type":75},140,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.\n\nThis 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.\n\nThe 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.",[81,82],"Bladder Stone","Cystolithiasis",[84,85,86],"Transurethral cystolithotripsy","Suprapubic drainage","Suprapubic catheter","2026-06-15",{"date":89,"type":90},"2026-06-16","ACTUAL",{"date":92,"type":90},"2026-06-08",{"date":94,"type":75},"2028-06",{"name":5,"class":6},1]