[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636459":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":45,"responsibleParty":63,"collaborators":26,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":69,"sex":75,"minAge":76,"maxAge":26,"enrollmentInfo":77,"targetDuration":26,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Ludwig-Maximilians - University of Munich","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ThuLEP Arm","EXPERIMENTAL","Thulium Laser Enucleation of the Prostate using a pulsed thulium laser system (wavelength approximately 2013 nm). The enucleation is performed according to the institutional standard operating procedure.",[13],"Procedure: Thulium Laser Enucleation of the Prostate (ThuLEP)",{"label":15,"type":16,"description":17,"interventionNames":18},"HoLEP Arm","ACTIVE_COMPARATOR","Holmium Laser Enucleation of the Prostate using a holmium:YAG laser system. Considered the current reference standard for endoscopic enucleation of the prostate.",[19],"Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Thulium Laser Enucleation of the Prostate (ThuLEP)","Endoscopic enucleation of the prostatic adenoma with a pulsed thulium laser; performed in arm 1",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Holmium Laser Enucleation of the Prostate (HoLEP)","Endoscopic enucleation of the prostatic adenoma with a holmium:YAG laser; performed in arm 2",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Yannic Volz, PD Dr. med.","LMU University Hospital","STUDY_CHAIR",{"name":37,"affiliation":34,"role":35},"Patrick Keller, PD Dr. med.",[39,43],{"name":33,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","+498944000","yannic.volz@med.uni-muenchen.de",{"name":37,"role":40,"phone":26,"phoneExt":26,"email":44},"patrick.keller@med.uni-muenchen.de",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Urologische Klinik und Poliklinik, LMU Klinikum","RECRUITING","Munich","Bavaria","81377","Germany","DE",{"type":55,"coordinates":56},"Point",[57,58],11.57549,48.13743,{"lat":58,"lon":57},[61],{"name":62,"role":40,"phone":41,"phoneExt":26,"email":44},"Patrick Keller",{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Yannic Volz","Consultant and Assistant Professor for Urology","100636459","holep-thulep---comparing-lasers-for-bph-surgery-100636459",false,"NCT07565961","HoLEP-ThuLEP - Comparing Lasers for BPH Surgery","Prospective Randomized Comparative Study Evaluating Functional and Perioperative Outcomes After Thulium Laser Enucleation of the Prostate (ThuLEP) Versus Holmium Laser Enucleation of the Prostate (HoLEP)","HOT","Inclusion Criteria:\n\n* Male, age ≥ 18 years\n* Clinically relevant benign prostatic syndrome (BPS) with an established indication for surgical treatment\n* International Prostate Symptom Score (IPSS) ≥ 8\n* Prostate volume \\> 40 ml\n* Signed written informed consent\n\nExclusion Criteria:\n\n* Proven or suspected prostate cancer\n* Previous surgery of the prostate or urethra\n* Neurogenic bladder dysfunction\n* Anticoagulation therapy that cannot be paused perioperatively","MALE","18 Years",{"count":78,"type":79},150,"ESTIMATED","INTERVENTIONAL",[82],"NA","Benign prostatic hyperplasia (BPH) is a very common condition in older men. As the prostate enlarges, it can press on the urethra and make urination difficult. Typical symptoms include a weak urinary stream, frequent urination, getting up at night to urinate, and a feeling that the bladder is not fully empty. When medication is no longer sufficient, surgical removal of the inner part of the prostate (\"enucleation\") is the recommended treatment.\n\nTwo modern laser techniques are used for this operation. Holmium Laser Enucleation of the Prostate (HoLEP) is currently considered the reference standard, with very good long-term results and a low rate of re-operations. Thulium Laser Enucleation of the Prostate (ThuLEP) using a pulsed thulium laser is a newer alternative. Because the laser energy is delivered in short pulses, ThuLEP may allow more precise tissue cutting and better control of bleeding during surgery.\n\nSo far, only limited high-quality randomized data directly compare the two techniques, particularly for patient-reported outcomes such as urinary symptoms, continence, and erectile function.\n\nPurpose of the study The HoT-Trial investigates whether ThuLEP is as effective as HoLEP for men who need surgery for an enlarged prostate, and whether there are differences in recovery, complication rates, urinary symptoms, continence, and erectile function after surgery.\n\nResearch question Does ThuLEP lead to a similar improvement in lower urinary tract symptoms (LUTS) as HoLEP 12 months after surgery, measured by the change in the International Prostate Symptom Score (IPSS)?\n\nHow the study works A total of 150 men aged 18 years or older with clinically relevant BPH, an IPSS of 8 or higher, a prostate volume above 40 ml, and an indication for surgery will take part. Each participant will be randomly assigned (1:1) to either ThuLEP or HoLEP. Participants are blinded to the assigned technique (single-blind design). Both procedures are established, guideline-recommended treatments; taking part in the study does not add any risks beyond standard care.\n\nBefore surgery, participants complete standardized questionnaires (IPSS, ICIQ-SF, IIEF) and undergo uroflowmetry and residual urine measurement. Surgery is performed according to randomization. Participants are then followed up in the urology outpatient clinic at discharge and at 3, 6, and 12 months after surgery. The same measurements and questionnaires are repeated at each visit.\n\nPrimary outcome Change in IPSS from baseline to 12 months after surgery.\n\nSecondary outcomes Maximum urinary flow rate (Qmax) and post-void residual urine; continence (ICIQ-SF) and erectile function (IIEF); operative time, laser time, blood loss, transfusion rate; catheter indwelling time and length of hospital stay; peri- and postoperative complications graded by the Clavien-Dindo classification; and the rate of re-intervention or re-catheterization within 12 months.\n\nSetting and timeline The study is conducted as a single-center trial at the Department of Urology, Ludwig-Maximilians-University Munich, Germany. Recruitment runs for approximately two years, with up to 12 months of follow-up per participant. The total study period is planned from April 2026 to April 2029.\n\nBy directly comparing the two laser enucleation techniques in a randomized setting, the HoT-Trial aims to help patients and physicians choose the most suitable surgical treatment for benign prostatic hyperplasia.",[85],"BPH (Benign Prostatic Hyperplasia)",[87,88,89,90,91,92,93],"BPH","BPS","Enculeation","Prostate","Laser","HOLEP","THULEP","2026-05-02",{"date":96,"type":97},"2026-05-07","ACTUAL",{"date":99,"type":79},"2026-06-01",{"date":101,"type":79},"2027-12-31",{"name":5,"class":6},1]