[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624945":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":51,"collaborators":26,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":26,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":26,"enrollmentInfo":61,"targetDuration":26,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":70,"overallStatus":39,"whyStopped":26,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A - Water Vapor Thermal Therapy (Rezum) group","EXPERIMENTAL","procedures will be performed with only sedation or under general anathesia according to the patient preference and anathesiologist recommendations in a lithotomy position.\n\nA single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area.\n\nThe procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.\n\nSaline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.\n\nInjection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site.\n\nAfter each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra.",[13],"Procedure: Rezum",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B - Prostatic Artery Embolization (PAE)","ACTIVE_COMPARATOR","Patients will undergo the procedure under local anathesia. The Patients will lie in supine position and sterilization of the groin will be done then puncture of the right femoral and\u002For left femoral artery will be done using puncture set after local anathesia.\n\n6F vascular sheath, then a 5F cobra head catheter will be introduced in right and\u002For left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division.\n\nAn ipsilateral oblique view (30-40 degrees) and\u002For cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \\& for identification of prostatic artery origin.\n\nSelective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.\n\nEmbolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.",[19],"Procedure: Prostatic Artery Embolization",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Rezum","A single-use transurethral delivery device with an 18-gauge retractable needle is used to inject steam into the targeted area with a fixed depth of 10.25 mm via 12 emitter holes spaced at the needle tip with an angle of 120°.\n\nThe procedure is visualized using an integrated cystoscope with a standard 4 mm 30° lens.\n\nSaline irrigation is used to improve visualization and to cool down the urethral surface during the procedure.\n\nInjection starts 1 cm distal to the bladder neck at 3 and 9 o'clock positions. Each injection deploys 0.5 ml of steam over 9 s at 103 °C raising the tissue temperature to 70 °C and it is recommended to wait for a couple of seconds postinjection to avoid loss of vapor through the puncture site.\n\nAfter each injection, the needle is retracted and reinserted 1 cm distal to the previous injection until the proximal edge of the verumontanum creating tissue ablation along the prostatic urethra.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Prostatic Artery Embolization","Sterilization of the groin will be done then puncture of the right femoral and\u002For left femoral artery will be done using puncture set after local anathesia.\n\n6F vascular sheath, then a 5F cobra head catheter will be introduced in right and\u002For left femoral artery to catheterize one of the internal iliac artery then catheterizing its anterior division.\n\nAn ipsilateral oblique view (30-40 degrees) and\u002For cranio-caudal view (10 degrees) will be obtained for differentiation of prostatic artery from other branches of anterior division \\& for identification of prostatic artery origin.\n\nSelective catheterization of prostatic artery with suitable type of micro catheter and adjusted microwire angle.\n\nEmbolizing material (400-500 micron microspheres) will be injected slowly and cautiously to avoid reflux under fluoroscopy guidance.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Seif AbdElmomen Yosef, MBBCh, MSc Faculty of Medicine","CONTACT","01093390291","siefabdelmomen@gmail.com",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":26},"RECRUITING","Cairo","Abbassia","00202","Egypt","EG",{"type":46,"coordinates":47},"Point",[48,49],31.24967,30.06263,{"lat":49,"lon":48},{"type":52,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100624945","comparison-between-water-vapor-thermal-therapy-and-prostatic-artery-embolization-in-treatment-of-benign-prostatic-hyperplasia-100624945",false,"NCT07416227","Comparison Between Water Vapor Thermal Therapy and Prostatic Artery Embolization in Treatment of Benign Prostatic Hyperplasia","Inclusion Criteria:\n\n* Age ≥50 years.\n* IPSS ≥13.\n* Prostate volume between 30-80 mL.\n* Maximum urinary flow rate (Qmax) ≤15 mL\u002Fsec in patients with voiding LUTs.\n* Patients not responding to medical treatment.\n\nExclusion Criteria:\n\n* History or suspicion of prostate cancer.\n* Previous prostate surgery or minimally invasive BPH intervention.\n* Neurological bladder dysfunction.\n* Active urinary tract infection.","MALE","50 Years",{"count":62,"type":63},30,"ESTIMATED","INTERVENTIONAL",[66],"NA","The aim of this study is to compare the effectiveness of Rezum therapy versus Prostatic Artery Embolization in managing moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), with the primary endpoint being the improvement in the International Prostate Symptom Score (IPSS) over a 6-month follow-up period. Secondary endpoints include changes in post-void residual urine (PVR), maximum urinary flow rate (Qmax), patient-reported quality of life (QoL), and the preservation of ejaculatory and overall sexual function as assessed by validated questionnaires. This study aims to provide evidence-based guidance for optimizing treatment strategies for men with BPH, particularly those seeking alternatives to pharmacological therapy.",[69],"Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms",[71,72],"Comparison between Water Vapor Thermal Therapy and Prostatic Artery Embolization in treatment of Benign Prostatic Hyperplasia","Rezum vs Prostatic artery embolization in the treatment of Benign prostatic hyperplasia with lower urinary tract symptoms","2026-02-14",{"date":75,"type":76},"2026-02-18","ACTUAL",{"date":78,"type":76},"2025-10-01",{"date":80,"type":63},"2027-10-01",{"name":5,"class":6},1]