[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637967":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":66,"collaborators":29,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":50,"whyStopped":29,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Beni-Suef University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Solifenacin","ACTIVE_COMPARATOR","Participants will receive oral solifenacin 5 mg once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.",[13],"Drug: Solifenacin",{"label":15,"type":16,"description":17,"interventionNames":18},"Melatonin","EXPERIMENTAL","Participants will receive oral melatonin 3 mg once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.",[19],"Drug: Melatonin",{"label":21,"type":16,"description":22,"interventionNames":23},"Solifenacin Plus Melatonin","Participants will receive oral solifenacin 5 mg once daily plus oral melatonin 3 mg once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.",[13,19],[25,30],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Solifenacin 5 mg orally once daily for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.",[9,21],null,{"type":26,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Melatonin 3 mg orally once nightly for 14 days after unilateral ureteroscopic lithotripsy with postoperative Double-J ureteral stent insertion.",[15,21],[34],{"name":35,"affiliation":36,"role":37},"Hany F Badawy, MD","Beni suef University hospital","PRINCIPAL_INVESTIGATOR",[39,43],{"name":35,"role":40,"phone":41,"phoneExt":29,"email":42},"CONTACT","+201149525028","HANYFATHY86@GMAIL.COM",{"name":44,"role":40,"phone":45,"phoneExt":29,"email":46},"Mahmoud Abdallah, MD","+201211874080","Drhanyfathy86@GMAIL.COM",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":29,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Department of Urology- Beni-Suef University Hospitals","RECRUITING","Banī Suwayf","BeniSuef","Egypt","EG",{"type":56,"coordinates":57},"Point",[58,59],31.09785,29.07441,{"lat":59,"lon":58},[62,64,65],{"name":35,"role":40,"phone":41,"phoneExt":29,"email":63},"Hanyfathy86@gmail.com",{"name":44,"role":40,"phone":45,"phoneExt":29,"email":46},{"name":35,"role":37,"phone":29,"phoneExt":29,"email":29},{"type":37,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Hany Fathy Badawy, MD","Lecturer of Urology, Faculty of Medicine, Beni-Suef University","100637967","phase-2-melatonin-and-solifenacin-for-double-j-ureteral-stent-symptoms-100637967",false,"NCT07617922","Melatonin and Solifenacin for Double-J Ureteral Stent Symptoms","Melatonin Versus Solifenacin Versus Their Combination for Improving Double-J Ureteral Stent-Related Symptoms and Quality of Life: A Prospective Randomized Study","MEL-SOL-STENT","Inclusion Criteria:\n\n1. Age 18 to 60 years.\n2. Patients undergoing unilateral ureteroscopy or ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent.\n3. Ability to understand and complete the study questionnaires.\n4. Willingness to participate and provide written informed consent.\n\nExclusion Criteria:\n\n1. Bilateral ureteral stents.\n2. Stents inserted for malignant ureteral obstruction or non-stone reconstructive indications.\n3. Known hypersensitivity or contraindication to solifenacin or melatonin.\n4. History of acute or chronic urinary retention, or evidence of clinically significant bladder outlet obstruction at baseline.\n5. History of narrow-angle glaucoma or other contraindications to antimuscarinic therapy, including gastric retention.\n6. Significant hepatic impairment.\n7. Severe renal impairment if judged clinically relevant to study medication safety.\n8. Pre-existing moderate to severe lower urinary tract symptoms unrelated to the stent.\n9. Recent use of antimuscarinics, alpha-blockers, or melatonin that may interfere with symptom assessment.\n10. Pregnancy or lactation.\n11. Inability to complete follow-up.","ALL","18 Years","60 Years",{"count":81,"type":82},189,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Double-J ureteral stents are commonly inserted after ureteroscopy, but they may cause bothersome urinary symptoms, pain, sleep disturbance, and reduced quality of life.\n\nThis prospective randomized assessor-blinded three-arm clinical trial will compare oral solifenacin, oral melatonin, and their combination for improving ureteral stent-related symptoms in adult patients after unilateral ureteroscopic lithotripsy with insertion of a unilateral Double-J ureteral stent.\n\nParticipants will be randomized to receive solifenacin 5 mg once daily, melatonin 3 mg once nightly, or combined solifenacin 5 mg once daily plus melatonin 3 mg once nightly for 14 days after surgery. The primary outcome is the total Ureteral Stent Symptom Questionnaire score at postoperative Day 7. Secondary outcomes include total Ureteral Stent Symptom Questionnaire score at Day 14, change in questionnaire score between Day 7 and Day 14, Insomnia Severity Index score, Visual Analogue Scale pain score, adverse events, treatment compliance, and rescue analgesic consumption.",[88,89,90],"Ureteral Stent-Related Symptoms","Ureteral Calculi","Lower Urinary Tract Symptoms",[92,93,94,9,15],"Double-J ureteral stent","Ureteral stent symptoms","Ureteral Stent Symptom Questionnaire","2026-05-29",{"date":97,"type":98},"2026-06-02","ACTUAL",{"date":100,"type":98},"2026-05-07",{"date":102,"type":82},"2027-05",{"name":5,"class":6},1]