Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:09 PM
Study NCT ID:
NCT07018934
Status:
COMPLETED
Last Update Posted:
2025-06-13
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alfuzosin and Mirabegron for Double-J Stent Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053040', 'term': 'Nephrolithiasis'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-22', 'size': 33509, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-22T14:11', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent-Related Pain Score', 'timeFrame': 'Day 7 postoperatively and Day 14 postoperatively.', 'description': 'Pain score ranges from 0 to 39 (higher scores indicate worse pain).'}, {'measure': 'Lower Urinary Tract Symptom (LUTS) Score', 'timeFrame': 'Day 7 postoperatively and Day 14 postoperatively', 'description': 'IPSS ranges from 0 to 35 (higher scores indicate more severe LUTS).'}], 'secondaryOutcomes': [{'measure': 'Stone-Free Rate', 'timeFrame': 'Day 14 postoperatively', 'description': 'Proportion of patients with no residual fragments \\> 2 mm on NCCT'}, {'measure': 'Residual Fragment Status', 'timeFrame': 'Day 14 postoperatively', 'description': 'Categorization of residual fragments into 0 mm, 1-2 mm, or \\> 2 mm'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nephrolithiasis', 'Ureteral Stent-Related Symptoms', 'Lower Urinary Tract Symptoms', 'Postoperative Pain', 'Retrograde Intrarenal Surgery'], 'conditions': ['Ureteral Stent-Related Symptoms']}, 'referencesModule': {'references': [{'pmid': '36244331', 'type': 'RESULT', 'citation': 'Zhang K, Yan W, Li H, Chen J, Wang Q, Chai Y, Yuan L, Zhu G. Comparison of Mirabegron plus Tamsulosin and Tamsulosin Monotherapy for the Treatment of Ureteral Stent-Related Symptoms: A Prospective Randomized Study. Urol Int. 2022;106(12):1226-1232. doi: 10.1159/000526607. Epub 2022 Oct 14.'}, {'pmid': '37556003', 'type': 'RESULT', 'citation': 'Uslu M, Yildirim U, Ezer M, Erihan IB, Sarica K. Residual fragment size following retrograde intrarenal surgery: a critical evaluation of related variables. Urolithiasis. 2023 Aug 9;51(1):100. doi: 10.1007/s00240-023-01478-8.'}, {'pmid': '35927160', 'type': 'RESULT', 'citation': 'Geraghty RM, Davis NF, Tzelves L, Lombardo R, Yuan C, Thomas K, Petrik A, Neisius A, Turk C, Gambaro G, Skolarikos A, Somani BK. Best Practice in Interventional Management of Urolithiasis: An Update from the European Association of Urology Guidelines Panel for Urolithiasis 2022. Eur Urol Focus. 2023 Jan;9(1):199-208. doi: 10.1016/j.euf.2022.06.014. Epub 2022 Aug 1.'}, {'pmid': '32928162', 'type': 'RESULT', 'citation': 'Yuk HD, Park J, Cho SY, Sung LH, Jeong CW. The effect of preoperative ureteral stenting in retrograde Intrarenal surgery: a multicenter, propensity score-matched study. BMC Urol. 2020 Sep 14;20(1):147. doi: 10.1186/s12894-020-00715-1.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing DJ stent placement after retrograde intrarenal surgery (RIRS) for renal stones. The primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (LUTS). Patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. Pain and LUTS will be assessed using validated questionnaires such as the Ureteral Stent Symptom Questionnaire (USSQ) and IPSS.', 'detailedDescription': 'Retrograde intrarenal surgery (RIRS) is a commonly used minimally invasive procedure for the treatment of renal stones. Postoperative placement of double-J (DJ) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (LUTS), which negatively impact patient quality of life. Alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. This study aims to compare the individual and combined efficacy of these agents on stent-related pain, LUTS, and postoperative stone outcomes. Patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-RIRS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients aged 18 to 75 years undergoing retrograde intrarenal surgery (RIRS) for renal stones, followed by double-J (DJ) stent placement', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Undergoing RIRS and DJ stenting\n\nAbility to provide informed consent\n\nExclusion Criteria:\n\n* Neurogenic bladder\n\nProstate volume \\>40 mL or significant LUTS at baseline\n\nContraindications to alpha-blockers or mirabegron\n\nHepatic or severe renal impairment'}, 'identificationModule': {'nctId': 'NCT07018934', 'briefTitle': 'Alfuzosin and Mirabegron for Double-J Stent Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Gaziantep'}, 'officialTitle': 'Comparison of the Efficacy of Alpha-Blockers and Mirabegron on Symptoms Associated With Double-J Stent Implanted After Retrograde Intrarenal Surgery', 'orgStudyIdInfo': {'id': '2024/05'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Group 1 : The group that did not receive medical treatment'}, {'label': '2', 'description': 'Group 2 : Alfuzosin 10 mg/d oral'}, {'label': '3', 'description': 'Group 3 : Mirabegron 50 mg/d oral'}, {'label': '4', 'description': 'Group 4 : Combination therapy with alfuzosin + Mirabegron'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaziantep', 'country': 'Turkey (Türkiye)', 'facility': 'Gaziantep University Faculty of Medicine Hospital', 'geoPoint': {'lat': 37.05944, 'lon': 37.3825}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data (IPD) will not be shared due to patient privacy concerns and institutional policy restrictions. However, summary results will be published in scientific journals and presented at academic meetings.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gaziantep', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'Mehmet Öztürk', 'investigatorAffiliation': 'University of Gaziantep'}}}}