[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572726":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":36,"centralContacts":49,"locations":54,"responsibleParty":71,"collaborators":27,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":27,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":27,"maxAge":81,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":57,"whyStopped":27,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Mansoura University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Oxybutynin and Trimethoprim\u002Fsulphamethoxazole","ACTIVE_COMPARATOR","Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim\u002Fsulphamethoxazole daily",[13,14],"Drug: Oxybutynin","Drug: Trimethoprim\u002Fsulfamethoxazole (TMP\u002FSMZ)",{"label":16,"type":17,"description":18,"interventionNames":19},"Tamsulosin, Oxybutynin and Trimethoprim\u002Fsulfamethoxazole","EXPERIMENTAL","Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim\u002Fsulfamethoxazole daily",[20,13,14],"Drug: Tamsulosin",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Tamsulosin","Children will be maintained on an oral dose of Tamsulosin 0.1 mg once daily (in children aged less than 2 years old) and 0.2 mg once daily (≥2 years old).",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Oxybutynin","Children will be maintained on an oral dose of Oxybutynin 0.2 mg\u002Fkg 2 times daily.",[9,16],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Trimethoprim\u002Fsulfamethoxazole (TMP\u002FSMZ)","Children will be maintained on an oral prophylactic dose of Trimethoprim\u002Fsulfamethoxazole 2 mg\u002Fkg single dose at night.",[9,16],[37,41,44,46],{"name":38,"affiliation":39,"role":40},"Ashraf Tarek Hafez","urology and nephrology center mansoura university","STUDY_CHAIR",{"name":42,"affiliation":39,"role":43},"Tamer Helmy","STUDY_DIRECTOR",{"name":45,"affiliation":39,"role":43},"Ahmed Elkashef",{"name":47,"affiliation":39,"role":48},"Mohamed Hussiny","PRINCIPAL_INVESTIGATOR",[50],{"name":47,"role":51,"phone":52,"phoneExt":27,"email":53},"CONTACT","+201064156383","mohamedhussiny1@yahoo.com",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Mansoura Urology and Nephrology Center","RECRUITING","Al Mansurah","Dakahlia Governorate","35511","Egypt","EG",{"type":64,"coordinates":65},"Point",[66,67],31.38069,31.03637,{"lat":67,"lon":66},[70],{"name":47,"role":51,"phone":52,"phoneExt":27,"email":53},{"type":72,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100572726","phase-3-efficacy-and-safety-of-tamsulosin-for-children-with-posterior-urethral-valve-100572726",false,"NCT06737016","Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.","Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Children with a diagnosis of PUV.\n\nExclusion Criteria:\n\n1. Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)\n2. Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.\n3. Patients who had primary treatment of PUV ablation at other hospitals.\n4. Contraindications to α blocker treatment.\n5. Patients who refuse to participate in the study","MALE","12 Years",{"count":83,"type":84},50,"ESTIMATED","INTERVENTIONAL",[87],"PHASE3","To determine whether there is a role for Tamsulosin, A Selective Alpha-1 Adrenergic Blocker, as therapy in children with Posterior Urethral Valve post valve ablation , and whether there are side effects involved.",[90],"Posterior Urethral Valve",[90],"2024-12-19",{"date":94,"type":95},"2024-12-20","ACTUAL",{"date":97,"type":95},"2024-11-01",{"date":99,"type":84},"2026-11",{"name":5,"class":6},1]