Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-01-09 @ 7:06 AM
Study NCT ID:
NCT02709304
Status:
UNKNOWN
Last Update Posted:
2016-03-16
First Post:
2016-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2016-03-09', 'studyFirstSubmitQcDate': '2016-03-11', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease postoperative urinary catheter related discomfort', 'timeFrame': 'Within 1 hour of emergence from general anesthetic', 'description': 'Subject and objective pain scale'}], 'secondaryOutcomes': [{'measure': 'decreased incidence of bacteriuria', 'timeFrame': 'immediate post catheter insertion and at 2 hour time point', 'description': 'Urine culture and colony counts'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['urinary catheter discomfort'], 'conditions': ['Urinary Catheter Discomfort in Surgical Patients']}, 'descriptionModule': {'briefSummary': 'This study will evaluate whether lidocaine gel for urinary catheter insertion would decrease pain and discomfort associate with Foley catheters upon awakening from general anesthesia in the post anesthesia care unit. As a secondary objective, the study will evaluate bacterial colony counts from urine obtained from the surgical patients after insertion of the Foley catheter prior to prophylactic antimicrobial administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males requiring catheterization for surgical procedures scheduled for less than 4 hours.\n\nExclusion Criteria:\n\n* Females, patients with preexisting urological conditions, and infections'}, 'identificationModule': {'nctId': 'NCT02709304', 'briefTitle': 'Efficacy of Lidocaine Gel in Reducing Foley Catheter Discomfort in Surgical Patients', 'organization': {'class': 'OTHER', 'fullName': 'Creighton University'}, 'officialTitle': 'Exploring the Potential Efficacy of Lidocaine Gel in Reducing Discomfort in Patients Undergoing Surgical Procedures Requiring Foley Catheter Placement', 'orgStudyIdInfo': {'id': '693571'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Gel', 'description': 'Standard gel not containing local anesthetic used to insert urinary catheters.', 'interventionNames': ['Drug: standard gel']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine Gel', 'description': 'lidocaine containing gel uses to insert urinary catheters', 'interventionNames': ['Drug: Lidocaine gel']}], 'interventions': [{'name': 'Lidocaine gel', 'type': 'DRUG', 'otherNames': ['Urojet'], 'description': 'Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used', 'armGroupLabels': ['Lidocaine Gel']}, {'name': 'standard gel', 'type': 'DRUG', 'description': 'Standard gel that is used to insert a urinary catheter that does not contain local anesthetic', 'armGroupLabels': ['Standard Gel']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mark D Reisbig, MD PhD', 'role': 'CONTACT', 'email': 'mdr44643@creighton.edu', 'phone': '402-449-4847'}], 'overallOfficials': [{'name': 'Mark D Reisbig, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Creighton University School of Medicine / CHI Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Creighton University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}