[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602499":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":53,"collaborators":25,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":56,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":25,"enrollmentInfo":66,"targetDuration":25,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":25,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Centro Universitário FMABC","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Alpha-blocker group","ACTIVE_COMPARATOR","Participants will receive an alpha-blocker (e.g., tamsulosin 0.4 mg orally once daily) for 7 consecutive days prior to flexible ureterorenolithotripsy. The medication aims to relax the ureteral smooth muscle and facilitate the insertion of the ureteral access sheath during surgery. All surgical procedures will follow the standard protocol used in the participating hospitals.",[13],"Drug: Experimental: Alpha-blocker group",{"label":15,"type":16,"description":17,"interventionNames":18},"No Intervention: Control group","PLACEBO_COMPARATOR","Participants will undergo flexible ureterorenolithotripsy without the use of alpha-blockers prior to surgery. All other aspects of perioperative care and surgical technique will be identical to those of the experimental group.",[19],"Drug: No intervention (observational study)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants in the experimental arm will receive an oral alpha-blocker (tamsulosin 0.4 mg) once daily for 7 consecutive days before undergoing flexible ureterorenolithotripsy. The medication is intended to relax ureteral smooth muscle fibers, potentially facilitating the insertion of the ureteral access sheath and reducing the need for a secondary procedure. The dose, route, and timing are standardized for all participants in this arm.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"No intervention (observational study)","Participants in this arm will undergo flexible ureterorenolithotripsy without receiving any alpha-blocker prior to surgery. All other perioperative care and surgical procedures will follow the same protocol as the experimental group.",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Pedro FB Buchalla, MD","CONTACT","+5516997704207","pedrofbuchalla@gmail.com",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Santo André","São Paulo","09060-870","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.53833,-23.66389,{"lat":48,"lon":47},[51],{"name":52,"role":33,"phone":34,"phoneExt":25,"email":35},"Pedro Buchalla",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Pedro de Figueiredo Buchalla","Alpha-Blockers Prior to Ureteral Access Sheath Placement in Flexible Ureteroscopy: A Randomized Prospective Study","100602499","phase-4-alpha-blockers-prior-to-ureteral-access-sheath-placement-in-flexible-ureteroscopy-a-randomized-prospective-study-100602499",false,"NCT07124299","Prospective, Randomized Study on the Efficiency of Alpha-Blockers Prior to Ureteral Sheath Placement in Flexible Ureterolithotripsy","ALFA-URS","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of nephrolithiasis with surgical indication for flexible ureterorenolithotripsy\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnancy\n* History of ureteral stricture, prior ureteral reconstructive surgery, and\u002For abdominal or pelvic radiotherapy\n* Prior ureteroscopy or ipsilateral double-J stent placement within the past 3 months\n* Chronic use of alpha-blockers for benign prostatic hyperplasia or medical expulsive therapy for ureteral stones","ALL","18 Years",{"count":67,"type":68},140,"ESTIMATED","INTERVENTIONAL",[71],"PHASE4","This study aims to evaluate whether the use of alpha-blockers before flexible ureterorenolithotripsy facilitates the passage of the ureteral access sheath. The trial will enroll adult patients diagnosed with kidney stones who are scheduled for flexible ureteroscopy. Participants will be randomly assigned to receive or not receive alpha-blockers for seven days before surgery. The primary outcome is the rate of successful sheath placement without the need for a second procedure. Secondary outcomes include the incidence of ureteral injuries and the need for additional surgical interventions. The goal is to improve surgical efficiency and patient outcomes in the treatment of kidney stones.",[74,75,76],"Nephrolithiasis","Alpha Blocker","Ureteral Access Sheath","2025-08-09",{"date":79,"type":80},"2025-08-15","ACTUAL",{"date":82,"type":80},"2024-01-01",{"date":84,"type":68},"2026-02-01",{"name":55,"class":6},1]