[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565990":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":150,"collaborators":24,"id":153,"slug":154,"hasResults":155,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":24,"eligibilityCriteria":159,"healthyVolunteers":155,"sex":160,"minAge":24,"maxAge":24,"enrollmentInfo":161,"targetDuration":24,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":172,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Fundacio Puigvert","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MoLEP","ACTIVE_COMPARATOR","Endoscopic Prostate Enucleation Using Moses 2.0 Technology Pulse modulation technology in Moses 2.0applied to Holmium Laser Endoscopic Prostate (MoLEP).",[13],"Device: MoLEP",{"label":15,"type":10,"description":16,"interventionNames":17},"BiTURP","Bipolar Transurethral Resection of the Prostate",[18],"Device: BiTURP",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Patients with an indication for surgery for BPH via EEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Patients with an indication for surgery for BPH viaEEAP with a prostate volume exceeding 80cc will be included in the study on a prospective basis. Surgery will be randomly assigned using MoLEP or BiTURP. A qualified surgeon, having completed their learning curve for endoscopic enucleation (more than 50cases) and possessing experience with both laser types, will perform the surgical procedure.",[15],[29],{"name":30,"affiliation":5,"role":31},"Ivan Schwartzmann Jochamowitz, MD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},"CONTACT","0034934169700","4608","ischwartzm@fundacio-puigvert.es",{"name":39,"role":34,"phone":35,"phoneExt":40,"email":41},"Silvia Mateu, MD","4602","smateu@fundacio-puigvert.es",[43,68,84,103,119,135],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Complejo Hospitalario Universitario de Santiago de Compostela","RECRUITING","Santiago de Compostela","A Coruña","15706","Spain","ES",{"type":52,"coordinates":53},"Point",[54,55],-8.54569,42.88052,{"lat":55,"lon":54},[58,62,64,66],{"name":59,"role":34,"phone":60,"phoneExt":24,"email":61},"Pérez Fentes, MD","0034 981 95 00 00","danielfentes@gmail.com",{"name":63,"role":34,"phone":60,"phoneExt":24,"email":24},"Lucía Mosquera, MD",{"name":63,"role":65,"phone":24,"phoneExt":24,"email":24},"SUB_INVESTIGATOR",{"name":67,"role":31,"phone":24,"phoneExt":24,"email":24},"Daniel Adolfo Pérez Fentes, MD",{"facility":5,"status":45,"city":69,"state":70,"zip":71,"country":49,"countryCode":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Barcelona","BARCELONA","08025",{"type":52,"coordinates":73},[74,75],2.15899,41.38879,{"lat":75,"lon":74},[78,79,81,82],{"name":30,"role":34,"phone":35,"phoneExt":36,"email":37},{"name":39,"role":34,"phone":80,"phoneExt":40,"email":41},"934169700",{"name":30,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":83,"role":65,"phone":24,"phoneExt":24,"email":24},"Javier Ponce de León, MD",{"facility":85,"status":86,"city":87,"state":70,"zip":88,"country":49,"countryCode":50,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Hospital Univesitari de Bellvitge","NOT_YET_RECRUITING","L'Hospitalet de Llobregat","08907",{"type":52,"coordinates":90},[91,92],2.10028,41.35967,{"lat":92,"lon":91},[95,99,101,102],{"name":96,"role":34,"phone":97,"phoneExt":24,"email":98},"Andreu Alabat Roca, MD","0034 932 60 75 00","Alband8989@gmail.com",{"name":100,"role":34,"phone":97,"phoneExt":24,"email":24},"Sergi Beato, MD",{"name":96,"role":31,"phone":24,"phoneExt":24,"email":24},{"name":100,"role":65,"phone":24,"phoneExt":24,"email":24},{"facility":104,"status":45,"city":105,"state":106,"zip":107,"country":49,"countryCode":50,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Universitario Marqués de Valdecillas","Santander","Cantabria","39008",{"type":52,"coordinates":109},[110,111],-3.80493,43.46589,{"lat":111,"lon":110},[114,118],{"name":115,"role":34,"phone":116,"phoneExt":24,"email":117},"Ester Fernández, MD","0034 942 20 25 20","esterferguz@gmail.com",{"name":115,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":120,"status":45,"city":121,"state":122,"zip":123,"country":49,"countryCode":50,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Hospital Universitario de Cabueñes","Gijón","Principality of Asturias","33394",{"type":52,"coordinates":125},[126,127],-5.66152,43.53573,{"lat":127,"lon":126},[130,134],{"name":131,"role":34,"phone":132,"phoneExt":24,"email":133},"Rebeca Blanco Fernández, MD","0034 985 18 50 00","rebecabfn@gmail.com",{"name":131,"role":31,"phone":24,"phoneExt":24,"email":24},{"facility":136,"status":45,"city":137,"state":137,"zip":138,"country":49,"countryCode":50,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Hospital Universitario Río Hortega","Valladolid","47012",{"type":52,"coordinates":140},[141,142],-4.72353,41.65541,{"lat":142,"lon":141},[145,149],{"name":146,"role":34,"phone":147,"phoneExt":24,"email":148},"Alejandro García Viña, MD","0034 983 42 04 00","ax_gv@hotmail.com",{"name":146,"role":31,"phone":24,"phoneExt":24,"email":24},{"type":31,"investigatorFullName":151,"investigatorTitle":152,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Ivan Schwartzmann, MD","Principal Investigator","100565990","comparison-between-bipolar-transurethral-resection-of-the-prostate-and-moses-assisted-holmium-laser-enucleation-of-the-prostate-100565990",false,"NCT06649357","Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate","Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate. A Prospective Randomized Multicentric Study","Inclusion Criteria:\n\n* Patients with maximum flow rate \\\u003C 15 ml\u002Fsec before obstructive surgery or with maximum flow rate \\> 15 ml\u002Fsec and urodynamic study showing high-flow obstruction defined as bladder outlet obstruction index \\> 40.\n* Patients with moderate to severe lower urinary tract symptoms (LUTS) according to the International Prostate Symptom Score (IPSS). Score between 8 and 35.\n* Patients with a prostate volume between 40 and 80 cc, measured by urological ultrasound or MRI.\n\nExclusion Criteria:\n\n* History of prior prostatic obstructive or urethral surgery.\n* Diagnosis of prostate neoplasia.\n* Diagnosis of urothelial neoplasia.\n* Lack of flowmetry or IPSS data before surgery.\n* Diagnosis or suspicion of hypo\u002Facontractile detrusor before prostatic obstructive surgery.\n* Diagnosis or suspicion of neurogenic bladder or neurological disease.\n* History of pelvic radiation therapy.","MALE",{"count":162,"type":163},130,"ESTIMATED","INTERVENTIONAL",[166],"NA","Introduction: Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay. On the other hand, no differences have been observed in terms of functional outcomes between both techniques, and surgical times reported in different studies tend to be longer for HoLEP. These results likely contribute to TURP, especially with bipolar energy (Bi-TURP), continuing to be considered by many the gold standard for surgical treatment of BPH.\n\nSofware and hardware upgrades to the Lumenis Pulse 120H. system in 2017, delivered MOSES 2.0, a single-use laser fibre used to perform MOSES augmented HoLEP (MoLEP). MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP. The availability of new morcellators might also decrease surgical time for HoLEP. This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP.\n\nPrimary Objective: To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP.\n\nSecondary objectives:\n\n* To compare the surgical time of MoLEP with that of Bi-TURP.\n* To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP.\n* To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP.\n* To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP.\n\nThis study is a prospective multicentric randomized and controlled trial. The study compares two types of BPH surgery without changing standard medical practice.\n\nThe study will include patients who are candidates according to standard medical practice for BPH surgery. Patients will be randomized to one of two groups of treatment.\n\n* The MoLEP group will receive surgical treatment with MoLEP.\n* The Bi-TURP group will receive surgical treatment with Bi-TURP. Surgical technique and postoperative care will follow standard clinical practice at each participating centre.",[169,170,171],"Prostate Hyperplasia","Surgery","Endoscopic Anatomical Enucleation of the Prostate (EEAP)",[173,170,174],"Prostate hyperplasia","Endoscopic anatomical enucleation of the prostate (EEAP)","2026-04-23",{"date":177,"type":178},"2026-04-29","ACTUAL",{"date":180,"type":178},"2025-04-01",{"date":182,"type":163},"2030-11",{"name":5,"class":6},6]