[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553824":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":70,"collaborators":39,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":39,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":39,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":39,"overallStatus":48,"whyStopped":39,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia","EXPERIMENTAL","50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects",[13],"Drug: Vardenafil 5 Mg Oral Tablet",{"label":15,"type":16,"description":17,"interventionNames":18},"Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia","ACTIVE_COMPARATOR","50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects",[13],{"label":20,"type":16,"description":21,"interventionNames":22},"Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia","50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects",[13],[24],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Vardenafil 5 Mg Oral Tablet","Comparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms )",[15,20,9],[30],"Vardenafil 5 mg",[32],{"name":33,"affiliation":5,"role":34},"Hazem B. Baz, M.B.B.Ch","PRINCIPAL_INVESTIGATOR",[36,41],{"name":33,"role":37,"phone":38,"phoneExt":39,"email":40},"CONTACT","00201020337967",null,"hazem30839637@med.tanta.edu.eg",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Mohamed G. Soliman, M.D","00201018362537","mohamed.soliman@med.tanta.edu.eg",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Faculity of medicine - Tanta university","RECRUITING","Tanta","Gharbia Governorate","31528","Egypt","EG",{"type":55,"coordinates":56},"Point",[57,58],31.00192,30.78847,{"lat":58,"lon":57},[61,64,68,69],{"name":62,"role":37,"phone":63,"phoneExt":39,"email":44},"Mohamed G. Soliman, MD","01018362537",{"name":65,"role":37,"phone":66,"phoneExt":39,"email":67},"Ahmed R. Abouramadan, MD","01001424064","ahmed.abouramadan@med.tanta.edu.eg",{"name":62,"role":34,"phone":39,"phoneExt":39,"email":39},{"name":33,"role":34,"phone":39,"phoneExt":39,"email":39},{"type":34,"investigatorFullName":71,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Hazem Bashir Ali Mohamed Baz","Urology resident at Tanta university hospitals","100553824","phase-3-medications-for-lower-urinary-tract-symptoms-secondary-to-benign-prostatic-hyperplasia-100553824",false,"NCT06491108","Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia","Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.","Inclusion Criteria:\n\n1. Sexually active patients .\n2. ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ).\n3. Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up .\n\nExclusion Criteria:\n\n1. Indication for combined therapy as prostate size over 40 gm .\n2. Gross hematuria.\n3. Refractory urine retention .\n4. Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia.\n5. Bladder diverticula or calculi .\n6. History of bladder or prostate cancer.\n7. Unwilling patients to medical therapy.\n8. History of pelvic surgery or urethral stricture.","MALE","40 Years","70 Years",{"count":84,"type":85},150,"ESTIMATED","INTERVENTIONAL",[88],"PHASE3","The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.",[91],"Enlarged Prostate With Lower Urinary Tract Symptoms","2024-07-05",{"date":94,"type":95},"2024-07-08","ACTUAL",{"date":97,"type":95},"2024-06-01",{"date":99,"type":85},"2025-07-01",{"name":5,"class":6},1]