[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640042":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":49,"centralContacts":54,"locations":59,"responsibleParty":111,"collaborators":36,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":36,"enrollmentInfo":124,"targetDuration":36,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":62,"whyStopped":36,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":148},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Capsule Plus Intraureteral Placebo","PLACEBO_COMPARATOR","Participants will receive a matching placebo capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral placebo using normal saline 0.9% during the procedure before attempted placement of the planned 10\u002F12 Fr ureteral access sheath.",[13,14],"Drug: Placebo Capsule","Drug: Intraureteral Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Tamsulosin Plus Intraureteral Placebo","EXPERIMENTAL","Participants will receive tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral placebo using normal saline 0.9% during the procedure before attempted placement of the planned 10\u002F12 Fr ureteral access sheath.",[20,14],"Drug: Tamsulosin",{"label":22,"type":17,"description":23,"interventionNames":24},"Placebo Capsule Plus Intraureteral Aminophylline","Participants will receive a matching placebo capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral aminophylline solution during the procedure before attempted placement of the planned 10\u002F12 Fr ureteral access sheath.",[13,25],"Drug: Intraureteral Aminophylline",{"label":27,"type":17,"description":28,"interventionNames":29},"Tamsulosin Plus Intraureteral Aminophylline","Participants will receive tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery and intraureteral aminophylline solution during the procedure before attempted placement of the planned 10\u002F12 Fr ureteral access sheath.",[20,25],[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Tamsulosin","Tamsulosin 0.4 mg capsule once daily for 7 days before retrograde intrarenal surgery.",[27,16],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Placebo Capsule","Matching placebo capsule for tamsulosin, taken once daily for 7 days before retrograde intrarenal surgery.",[22,9],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Intraureteral Aminophylline","Aminophylline 250 mg\u002F10 mL will be diluted with 10 mL normal saline 0.9% to a total volume of 20 mL. The solution will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10\u002F12 Fr ureteral access sheath.",[22,27],{"type":32,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Intraureteral Placebo","Normal saline 0.9% to a total volume of 20 mL will be instilled intraureterally through an open-end ureteric catheter positioned in the distal ureter on the study side. After a standardized 5-minute waiting period, one controlled attempt will be made to place the planned 10\u002F12 Fr ureteral access sheath.",[9,16],[50],{"name":51,"affiliation":52,"role":53},"Hany F Badawy, MD","Faculty of Medicine, Beni-Suef University","PRINCIPAL_INVESTIGATOR",[55],{"name":51,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","+201149525028","Hanyfathy86@gmail.com@GMAIL.COM",[60,82,96],{"facility":61,"status":62,"city":63,"state":64,"zip":36,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Department of Urology- Aswan University Hospitals","RECRUITING","Aswān","Aswan Governorate","Egypt","EG",{"type":68,"coordinates":69},"Point",[70,71],32.89942,24.09082,{"lat":71,"lon":70},[74,78,80],{"name":75,"role":56,"phone":76,"phoneExt":36,"email":77},"Ahmed Ahmed, MD","+20 11 00299002","ahmed.salaheldien@aswu.edu.eg",{"name":79,"role":56,"phone":36,"phoneExt":36,"email":36},"Ahmed",{"name":81,"role":53,"phone":36,"phoneExt":36,"email":36},"Ahmed S Ahmed, MD",{"facility":83,"status":62,"city":84,"state":85,"zip":36,"country":65,"countryCode":66,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Department of Urology- Beni-Suef University Hospitals","Banī Suwayf","Beni Suweif Governorate",{"type":68,"coordinates":87},[88,89],31.09785,29.07441,{"lat":89,"lon":88},[92,95],{"name":51,"role":56,"phone":93,"phoneExt":36,"email":94},"+2","Hanyfathy86@gmail.com",{"name":51,"role":53,"phone":36,"phoneExt":36,"email":36},{"facility":97,"status":62,"city":98,"state":99,"zip":36,"country":65,"countryCode":66,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Urology Department- Sohag university Hospital","Sohag","Sohag Governorate",{"type":68,"coordinates":101},[102,103],31.69478,26.55695,{"lat":103,"lon":102},[106,110],{"name":107,"role":56,"phone":108,"phoneExt":36,"email":109},"Ahmed M Elsherif, MD","+20 10 07385302","Ahmed-mahmoud@med.sohag.edu.eg",{"name":107,"role":53,"phone":36,"phoneExt":36,"email":36},{"type":53,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Hany Fathy Badawy, MD","Lecturer of Urology, Faculty of Medicine, Beni-Suef University","100640042","phase-2-tamsulosin-and-intraureteral-aminophylline-for-ureteral-access-during-rirs-100640042",false,"NCT07623876","Tamsulosin and Intraureteral Aminophylline for Ureteral Access During RIRS","Comparative Efficacy of Tamsulosin, Intraureteral Aminophylline, and Their Combination in Facilitating Ureteral Access During Retrograde Intrarenal Surgery: A Multicenter Randomized Controlled Trial.","TAM-AMIN-UAS","Inclusion Criteria:\n\n* Age 18 years or older.\n* Unilateral renal stone 2 cm or less in maximal diameter on preoperative imaging.\n* Scheduled for primary retrograde intrarenal surgery.\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior ureteral stenting on the study side.\n* Bilateral same-session retrograde intrarenal surgery.\n* Concomitant ureteral stone requiring primary semirigid ureteroscopy as the main procedure.\n* Known ureteral stricture or prior ureteral reconstructive surgery on the study side.\n* Active urinary tract infection or untreated positive urine culture.\n* Pregnancy.\n* Known allergy or contraindication to tamsulosin or aminophylline.\n* Significant cardiac arrhythmia, uncontrolled ischemic heart disease, seizure disorder, or hyperthyroidism.\n* Severe hepatic impairment.\n* Inability to comply with the 7-day preoperative medication protocol.","ALL","18 Years",{"count":125,"type":126},322,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This multicenter randomized controlled trial will evaluate whether preoperative tamsulosin, intraureteral aminophylline, or their combination can improve ureteral access during primary retrograde intrarenal surgery for renal stones. Adult patients with unilateral renal stones measuring 2 cm or less and planned placement of a 10\u002F12 Fr ureteral access sheath will be randomly assigned to one of four groups in a 2x2 factorial design. Participants will receive either tamsulosin or placebo for 7 days before surgery and either intraureteral aminophylline or intraureteral placebo during the procedure. The main outcome will be successful first-attempt placement of the planned 10\u002F12 Fr ureteral access sheath after study solution instillation, without active ureteral dilatation, sheath downsizing, prestenting with deferred surgery, or abandonment of the procedure due to access failure.",[132,133,134],"Renal Stones","Retrograde Intrarenal Surgery","Ureteral Access Sheath Placement",[136,33,137,138],"Retrograde intrarenal surgery","Intraureteral aminophylline","ureteral access sheath","2026-05-28",{"date":141,"type":142},"2026-06-03","ACTUAL",{"date":144,"type":142},"2026-05-06",{"date":146,"type":126},"2027-05",{"name":5,"class":6},3]