Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 10:48 AM
Study NCT ID:
NCT03537534
Status:
TERMINATED
Last Update Posted:
2024-02-26
First Post:
2018-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraurethral Lidocaine After Endourology Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053159', 'term': 'Dysuria'}], 'ancestors': [{'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C008371', 'term': 'phenylmercury borate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-23', 'studyFirstSubmitDate': '2018-05-15', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subjective patient symptom score', 'timeFrame': '1 day (immediately before and after procedure)', 'description': 'questionnaire scores'}], 'secondaryOutcomes': [{'measure': 'Patient complications', 'timeFrame': 'within 30 days', 'description': 'Unplanned patient returns to clinic or ED, UTIs, admissions'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dysuria']}, 'descriptionModule': {'briefSummary': 'Many urological conditions are diagnosed and treated with the use of endourology procedures. Unfortunately, dysuria is a common patient complaint following these procedures. Intraurethral lidocaine instillation is regularly used prior to office-based endourology procedures to alleviate dysuria, as well as, discomfort during the procedure.. Studies have confirmed that office-based procedures using intraurethral lidocaine have resulted in less patient reported dysuria. Many endourology procedures are done under general anesthesia such as urinary stone treatments or resection of bladder tumors. There is a paucity of data regarding the use of intraurethral lidocaine at the conclusion of these procedures evaluating patient reported dysuria. We have designed a prospective, randomized, placebo controlled trial to evaluate the role of intraurethral lidocaine instillation following endourology procedures in the anesthetized patient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: Adult patients, age 18 and older scheduled to undergo endourologic procedure to include ureteroscopy, rigid diagnostic cystoscopy, bladder biopsy, laser lithotripsy, cystolithalopaxy, and transurethral resection of bladder tumor in the operating room under general anesthesia.\n\n\\-\n\nExclusion Criteria: active urinary tract infection, current dysuria symptoms, pregnant females, urethral stricture disease, indwelling foley catheter, and history of pelvic radiation\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03537534', 'briefTitle': 'Intraurethral Lidocaine After Endourology Procedures', 'organization': {'class': 'FED', 'fullName': 'San Antonio Uniformed Services Health Education Consortium'}, 'officialTitle': 'Intraurethral Lidocaine After Endourology Procedure to Improve Dysuria in Anesthetized Patients', 'orgStudyIdInfo': {'id': 'C.2018.055d'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experiment', 'description': 'Lidocaine jelly (2%) 5mL x 1 dose only', 'interventionNames': ['Drug: Lidocaine Jet Injector']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Surgilube 5mL x 1 dose only', 'interventionNames': ['Drug: Placebos']}], 'interventions': [{'name': 'Lidocaine Jet Injector', 'type': 'DRUG', 'otherNames': ['Urojet'], 'description': 'Applying Lidocaine following endourologic procedure', 'armGroupLabels': ['Experiment']}, {'name': 'Placebos', 'type': 'DRUG', 'otherNames': ['Surgilube'], 'description': 'Applying surgilube following endourologic procedure', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78234', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'BAMC', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}], 'overallOfficials': [{'name': 'Christopher Allam, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'San Antonio Uniformed Services Health Education Consortium'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'San Antonio Uniformed Services Health Education Consortium', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Endourology and Laparoscopy', 'investigatorFullName': 'Christopher Allam', 'investigatorAffiliation': 'San Antonio Uniformed Services Health Education Consortium'}}}}