Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-25 @ 7:55 AM
Study NCT ID:
NCT03709992
Status:
SUSPENDED
Last Update Posted:
2023-10-12
First Post:
2018-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Kuwait']}, 'conditionBrowseModule': {'meshes': [{'id': 'D053039', 'term': 'Ureterolithiasis'}, {'id': 'D014517', 'term': 'Ureteral Obstruction'}], 'ancestors': [{'id': 'D014515', 'term': 'Ureteral 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C003330', 'term': 'trospium chloride'}, {'id': 'D000077409', 'term': 'Tamsulosin'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Because of COVID-19 Crisis', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2018-10-15', 'studyFirstSubmitQcDate': '2018-10-15', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ureteral Stent Symptoms Questionnaire (USSQ) score', 'timeFrame': '14 days', 'description': 'Quantitative assessment of quality of life score'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': '14 days', 'description': 'Assessment of side effects of the drug used'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ureteral stent', 'USSQ', 'Tamsulosin', 'Trospium Chloride'], 'conditions': ['Ureter Stone', 'Quality of Life', 'Ureter Obstruction']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare the efficacy and safety of Trospium chloride versus Tamsulosin for treatment of ureteral stent related symptoms.', 'detailedDescription': 'Eligible patients will be randomized to one of the two treatment groups. Group 1 patients will receive 30 mg of Trospium chloride tablet twice daily, while group 2 patients will receive 0.4 mg of Tamsulosin tablet once daily, until the stent is removed. Ureteral Stent Symptoms Questionnaire (USSQ) will be used to evaluate the symptoms of the patients with DJ stent after 2 weeks of inserting the stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with double "J" (DJ) stent after ureteroscopy or for drainage of obstructed kidney\n\nExclusion Criteria:\n\n1. Patients with hypersensitivity to either Trospium chloride or Tamsulosin\n2. Patients with complications after DJ insertion (such as fever, hematuria, perforation, stent migration).\n3. Patients receiving alpha blockers or anticholinergic medications for any other reason.\n4. Patients with history of orthostatic hypotension.\n5. Pregnant or breastfeeding females.\n6. Patients with hepatic impairment (Child-Pugh score \\>9).\n7. Patients with severe renal impairment with creatinine clearance of less than 15 mL/min.\n8. Patients with narrow-angle glaucoma.\n9. Patients with history of urinary retention or gastric retention.'}, 'identificationModule': {'nctId': 'NCT03709992', 'briefTitle': 'Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms:', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Trospium Chloride vs Tamsulosin in Treatment of Ureteral Stent Related Symptoms: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Trospium vs Tamsulosin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trospium', 'description': 'Patients will receive 30 mg of Trospium chloride tablet twice daily', 'interventionNames': ['Drug: Trospium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tamsulosin', 'description': 'Patients will receive 0.4 mg of Tamsulosin tablet once daily', 'interventionNames': ['Drug: Tamsulosin']}], 'interventions': [{'name': 'Trospium Chloride', 'type': 'DRUG', 'otherNames': ['Spasmix'], 'description': '30 mg of Trospium chloride tablet twice daily', 'armGroupLabels': ['Trospium']}, {'name': 'Tamsulosin', 'type': 'DRUG', 'otherNames': ['Omnic'], 'description': '0.4 mg of Tamsulosin tablet once daily', 'armGroupLabels': ['Tamsulosin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'state': 'Kuwait', 'country': 'Egypt', 'facility': 'Ahmed R EL-Nahas', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Abdullatif AL-Terki, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Amiri Hospital - Kuwait'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Amiri Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Urology', 'investigatorFullName': 'Ahmed R. EL-Nahas', 'investigatorAffiliation': 'Mansoura University'}}}}