[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640806":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":54,"responsibleParty":80,"collaborators":30,"id":83,"slug":30,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":86,"acronym":30,"eligibilityCriteria":87,"healthyVolunteers":88,"sex":89,"minAge":30,"maxAge":30,"enrollmentInfo":90,"targetDuration":30,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":57,"whyStopped":30,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"ThuFLEP Group","ACTIVE_COMPARATOR","30 patients undergoing Thulium Fiber Laser Enucleation of the Prostate using Quanta 60W with 550nm Thulium fiber",[13],"Procedure: Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)",{"label":15,"type":10,"description":16,"interventionNames":17},"HoLEP Group","30 patients undergoing Holmium Laser Enucleation of the Prostate using Quanta 150W with 550nm Holmium YAG fiber",[18],"Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)",{"label":20,"type":10,"description":21,"interventionNames":22},"Bipolar Enucleation Group","30 patients undergoing Bipolar Transurethral Enucleation of the Prostate using standard bipolar energy",[23],"Procedure: Bipolar Transurethral Enucleation of the Prostate (B-TUEP)",[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Thulium Fiber Laser Enucleation of the Prostate (ThuFLEP)","Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta thulium fiber laser at 60 watts with a 550 μm thulium fiber. Enucleated tissue was removed using a morcellator.",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"Holmium Laser Enucleation of the Prostate (HoLEP)","Anatomical endoscopic enucleation of the prostate performed transurethrally using a Quanta holmium YAG laser at 150 watts with a 550 μm holmium fiber. Enucleated tissue was removed using a morcellator.",[15],{"type":26,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Bipolar Transurethral Enucleation of the Prostate (B-TUEP)","Anatomical endoscopic enucleation of the prostate performed transurethrally using standard bipolar electrical energy. Enucleated tissue was removed using a morcellator.",[20],[40],{"name":41,"affiliation":42,"role":43},"Hassan Hussein El-Tatawy, MD","Tanta University Faculty of Medicine","STUDY_DIRECTOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},"Abdullah Salah Al Debeiky, MD","CONTACT","+201221430915","abdullah.aldebeiky@med.tanta.edu.eg",{"name":51,"role":47,"phone":52,"phoneExt":30,"email":53},"Omar Khaled Gad, MSc","+201117837272","omar_khaled@med.tanta.edu.eg",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Tanta University Hospital","RECRUITING","Tanta","Gharbia Governorate","31111","Egypt",{"type":63,"coordinates":64},"Point",[65,66],31.00192,30.78847,{"lat":66,"lon":65},[69,70,71,73,75,77,79],{"name":51,"role":47,"phone":52,"phoneExt":30,"email":53},{"name":46,"role":47,"phone":48,"phoneExt":30,"email":49},{"name":51,"role":72,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"name":41,"role":74,"phone":30,"phoneExt":30,"email":30},"SUB_INVESTIGATOR",{"name":76,"role":74,"phone":30,"phoneExt":30,"email":30},"Mohamed Hassan Radwan, MD",{"name":78,"role":74,"phone":30,"phoneExt":30,"email":30},"Mohamed Osama Abou Farha, MD",{"name":46,"role":74,"phone":30,"phoneExt":30,"email":30},{"type":72,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Abdullah Salah Al Debeiky","Lecturer of Urology","100640806",false,"NCT07627178","A Prospective Comparative Study Evaluating the Safety and Efficacy of Transurethral Thulium Fiber Laser, Holmium Laser and Bipolar Enucleation of Large Sized Prostate","Inclusion Criteria:\n\n* Male patients diagnosed with BPH\n* Clinical diagnosis of BPH with lower urinary tract symptoms.\n* IPSS ≥ 20 (severe symptoms)\n* Maximum urinary flow rate (Qmax) ≤ 10 mL\u002Fs\n* Prostate volume \\>100 mL (measured by transrectal ultrasound)\n* Failed medical therapy and fit for operation\n\nExclusion Criteria:\n\n* Prostate cancer (current or history).\n* Previous prostate surgery\n* Previous urethral surgery.\n* Neurogenic bladder dysfunction.\n* Active urinary tract infection.\n* Severe cardiovascular disease (ASA Class IV).\n* Previous pelvic radiation.\n* Urethral stricture\n* Urinary bladder stones.",true,"MALE",{"count":91,"type":92},90,"ESTIMATED","INTERVENTIONAL",[95],"NA","This study compares the safety and efficacy of three endoscopic enucleation techniques for large prostates (\\>100 mL) in patients with benign prostatic hyperplasia (BPH): Thulium Fiber Laser Enucleation (ThuFLEP), Holmium Laser Enucleation (HoLEP), and Bipolar Enucleation (B-TUEP). Ninety male patients with severe lower urinary tract symptoms (IPSS ≥20, Qmax ≤10 mL\u002Fs) who failed medical therapy will be randomized 1:1:1 into three groups of 30. Primary outcomes include IPSS, quality of life score, maximum flow rate (Qmax), and post-void residual at 1, 3, and 6 months postoperatively. Secondary outcomes include operative time, enucleation efficiency, blood loss, catheterization duration, hospital stay, and complication rates assessed by the Clavien-Dindo classification.",[98,99,100],"Benign Prostatic Hyperplasia (BPH)","Lower Urinary Tract Symptom","Bladder Outlet Obstruction",[102,103,104,105,106,107,108,109],"Prostate Enucleation","ThuLEP","HOLEP","Bi-TUEP","TFL","BPH Surgery","IPSS","Uroflowmetry","2026-06-03",{"date":112,"type":113},"2026-06-05","ACTUAL",{"date":115,"type":113},"2025-10-21",{"date":117,"type":92},"2027-05-30",{"name":5,"class":6},1]