Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2026-01-11 @ 5:29 AM
Study NCT ID:
NCT02266368
Status:
COMPLETED
Last Update Posted:
2016-09-13
First Post:
2014-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2014-10-11', 'studyFirstSubmitQcDate': '2014-10-11', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of urinary tract infection (UTI)', 'timeFrame': 'up to 3 months', 'description': 'UTI will be diagnosed with urine and stent culture of stent removal'}], 'secondaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': 'up to 3 months', 'description': 'The impact of stent coating on quality of life will be assissed with ureteral stent symptom questionnaire (USSQ)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ureteral stents', 'Double J stent', 'Antimicoreal coated stent', 'USSQ', 'UTI'], 'conditions': ['Quality of Life']}, 'descriptionModule': {'briefSummary': 'This study will be conducted to compare the efficacy of antimicrobial coated ureteral stent with non-coated stents in prevention of UTI in patients with ureteral stents', 'detailedDescription': "The efficacy of antimicrobial coated of ureteral stent with silver sulphadiazine in prevention of UTI in patients with ureteral stents will be studied by comparining the results of urine and stent cultures with patients who had non-coated ureteral stents. The impact of antimicrobeal stent coating on patients' quality of life will be evaluated with comparing the scores of ureteral stent symptom questionnaire between both groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will undergo ureteral stent placement\n\nExclusion Criteria:\n\n* Patients allergic to sulpha containing medications\n* Ureteral stent insertion for infected hydronephrosis\n* Patients who developed septic complications requiring antibiotic treatment after stent placement\n* Patients who need bilateral stents\n* Patients with chronic kidney disease grade IV and V (GFR \\<30ml/min)\n* Immunocompromised patients as those with malignancy or organ transplantation.'}, 'identificationModule': {'nctId': 'NCT02266368', 'briefTitle': 'Comparison of Antimicrobial Coated Ureteral Stents With Non-coated Stents', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'A Randomized Controlled Trial Comparing Antimicrobial Coated (Silver Sulfadiazine) Ureteral Stents With Non-coated Stents', 'orgStudyIdInfo': {'id': 'Antimicrobeal ureteral stents'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'This arm will include patients with non-coated stents'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antimicrobeal group', 'description': 'This arm will include patients with antimicrobeal coated stents', 'interventionNames': ['Device: Antimicrobeal coated stents']}], 'interventions': [{'name': 'Antimicrobeal coated stents', 'type': 'DEVICE', 'description': 'Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents', 'armGroupLabels': ['Antimicrobeal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Urology and Nephrology Center', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ahmed R EL-NAHAS, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professour, urology department, urology and nephrology center, mansoura university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Ahmed R. EL-Nahas', 'investigatorAffiliation': 'Mansoura University'}}}}