[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641924":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":55,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Water Vapor Thermal Therapy","ACTIVE_COMPARATOR","Patients in this group will undergo transurethral convective radiofrequency water vapor thermal therapy using the Rezum system for symptomatic benign prostatic hyperplasia. Vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.",[13],"Procedure: Water Vapor Thermal Therapy",{"label":15,"type":10,"description":16,"interventionNames":17},"Ejaculation-Preserving Holmium Laser Enucleation of the Prostate","Patients in this group will undergo Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.",[18],"Procedure: Ejaculation-Preserving Holmium Laser Enucleation of the Prostate",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Transurethral convective radiofrequency water vapor thermal therapy for symptomatic benign prostatic hyperplasia. Water vapor injections will be delivered into the obstructing prostatic tissue according to prostate configuration and prostatic urethral length. Median lobe treatment will be performed when present and technically suitable. A Foley catheter will be inserted at the end of the procedure.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Holmium Laser Enucleation of the Prostate using an ejaculation-preserving modification for symptomatic benign prostatic hyperplasia. The technique will aim to preserve supramontanal and perimontanal tissue near the verumontanum and preserve bladder-neck fibers when technically feasible, while performing anatomical enucleation of the obstructing prostatic adenoma. A Foley catheter will be inserted at the end of the procedure.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Hany F Badawy, MD","CONTACT","+201149525028","HANYFATHY86@GMAIL.COM",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Department of Urology- Beni-Suef University Hospitals","RECRUITING","Banī Suwayf","Beni Suweif Governorate","02456","Egypt","EG",{"type":44,"coordinates":45},"Point",[46,47],31.09785,29.07441,{"lat":47,"lon":46},[50,52,53],{"name":51,"role":31,"phone":32,"phoneExt":24,"email":33},"F Badawy, MD",{"name":24,"role":31,"phone":24,"phoneExt":24,"email":33},{"name":30,"role":54,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Hany Fathy Badawy, MD","Lecturer of Urology, Faculty of Medicine, Beni-Suef University","100641924","water-vapor-thermal-therapy-versus-ejaculation-preserving-holep-for-benign-prostatic-hyperplasia-100641924",false,"NCT07648875","Water Vapor Thermal Therapy Versus Ejaculation-Preserving HoLEP for Benign Prostatic Hyperplasia","Water Vapor Thermal Therapy Versus Ejaculation-Preserving Holmium Laser Enucleation of the Prostate for Benign Prostatic Hyperplasia: A Prospective Comparative Study","Inclusion Criteria:\n\n* Male patients aged 50 years or older.\n* Symptomatic benign prostatic hyperplasia with moderate-to-severe lower urinary tract symptoms.\n* International Prostate Symptom Score (IPSS) of 13 or higher.\n* Prostate volume 30 to 80 mL measured by transrectal ultrasound.\n* Maximum urinary flow rate (Qmax) of 15 mL\u002Fs or less with voided volume of at least 150 mL.\n* Post-void residual urine volume of 250 mL or less.\n* Failure, intolerance, or unwillingness to continue medical therapy for benign prostatic hyperplasia.\n* Sexually active within the previous 3 months.\n* Preserved antegrade ejaculation at baseline.\n* Patient wishes to preserve ejaculation.\n* Ability to complete the International Prostate Symptom Score (IPSS), International Index of Erectile Function-5 (IIEF-5), and Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF).\n* Written informed consent.\n\nExclusion Criteria:\n\n* Suspected or confirmed prostate cancer.\n* Abnormal prostate-specific antigen or digital rectal examination suspicious for malignancy unless prostate cancer has been excluded according to standard clinical practice.\n* Previous prostate surgery.\n* Previous urethral surgery likely to affect instrumentation or study outcomes.\n* Urethral stricture disease.\n* Neurogenic bladder dysfunction.\n* Active urinary tract infection until adequately treated.\n* Bladder stones requiring concomitant surgery.\n* Prostate volume less than 30 mL or more than 80 mL.\n* Baseline anejaculation or severe ejaculatory dysfunction.\n* No sexual activity during the previous 3 months.\n* Chronic indwelling urethral or suprapubic catheter.\n* Suspected detrusor underactivity requiring urodynamic clarification.\n* Post-void residual urine volume more than 250 mL.\n* Uncontrolled coagulopathy.\n* Anticoagulation or antiplatelet therapy that cannot be safely managed perioperatively.\n* Unfitness for anesthesia or intervention.\n* Inability or unwillingness to comply with follow-up.","MALE","50 Years",{"count":68,"type":69},120,"ESTIMATED","INTERVENTIONAL",[72],"NA","This prospective comparative study will evaluate Water Vapor Thermal Therapy (Rezum) versus ejaculation-preserving Holmium Laser Enucleation of the Prostate (EP-HoLEP) in sexually active men with symptomatic benign prostatic hyperplasia and prostate volume 30-80 mL.\n\nEligible patients will not be randomized. The treatment option will be selected through shared decision-making between the patient and treating physician after standardized counseling about the expected benefits, risks, recovery, catheter duration, urinary outcomes, durability, and potential effects on ejaculation and sexual function.\n\nThe main objective is to compare the change in ejaculatory function from baseline to 12 months using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction-Short Form (MSHQ-EjD-SF) Function domain. Secondary outcomes will include urinary symptom improvement, quality of life, maximum urinary flow rate, post-void residual urine volume, erectile function, antegrade ejaculation preservation, catheterization duration, hospital stay, complications, restart of benign prostatic hyperplasia medication, and retreatment or reintervention within 12 months.",[75,76],"Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms",[9,78,79,80],"Rezum","Ejaculation-Preserving HoLEP","Male Sexual Health Questionnaire","2026-06-10",{"date":83,"type":84},"2026-06-15","ACTUAL",{"date":86,"type":84},"2026-06-08",{"date":88,"type":69},"2027-12",{"name":5,"class":6},1]