Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 3:15 AM
Study NCT ID:
NCT07447518
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double j Stent Related Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}], 'ancestors': [{'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}, {'id': 'C520025', 'term': 'mirabegron'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-26', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2026-02-26', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Double j related symptoms', 'timeFrame': 'Six weeks', 'description': 'Double j related symptoms questionnaire score'}], 'secondaryOutcomes': [{'measure': 'Sex matters related double j stent', 'timeFrame': 'Six weeks', 'description': 'Sex matters related stent'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LUTS', 'Double j'], 'conditions': ['Lower Urinary Tract Symptoms']}, 'descriptionModule': {'briefSummary': 'In urology, ureteral stents are used to treat obstructive diseases. Hematuria (54%), fever, discomfort, and lower urinary system symptoms are the predominant symptoms related to ureteral stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age above 18 years\n* any patient need post urs or pcnl double stent\n\nExclusion Criteria:\n\n* age less than 18 years\n* known over active bladder patient'}, 'identificationModule': {'nctId': 'NCT07447518', 'briefTitle': 'Double j Stent Related Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Comparison of Mirabegron ,Tamsulosin and Solifenacinin Relieving Double -J Stent Related Symptoms : Approspective Randmized Placebo Controlledtrial', 'orgStudyIdInfo': {'id': '35806/9/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A : patients will receive tadalafil', 'interventionNames': ['Drug: Tadalafil 5mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B: patients will receive solidosin', 'interventionNames': ['Drug: solidosin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C: patients will receive solfenacin', 'interventionNames': ['Drug: Solfenacin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group D: patients will receive mirabegron', 'interventionNames': ['Drug: Mirabegron']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group E: patients will receive placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tadalafil 5mg', 'type': 'DRUG', 'description': 'once daily 5mg', 'armGroupLabels': ['Group A : patients will receive tadalafil']}, {'name': 'solidosin', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Group B: patients will receive solidosin']}, {'name': 'Solfenacin', 'type': 'DRUG', 'description': 'once dialy', 'armGroupLabels': ['Group C: patients will receive solfenacin']}, {'name': 'Mirabegron', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Group D: patients will receive mirabegron']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily', 'armGroupLabels': ['Group E: patients will receive placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44749', 'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Elsayed Abdelhalim', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer, urology department, Kafrelsheikh university', 'investigatorFullName': 'Elsayed Abdelhalim Elsayed', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}