Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2025-12-31 @ 8:37 PM
Study NCT ID:
NCT05408533
Status:
COMPLETED
Last Update Posted:
2024-11-25
First Post:
2022-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Silver-Coated vs Standard Catheter for UTI Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 310}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2022-04-29', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of UTIs requiring treatment', 'timeFrame': 'approximately 4 weeks', 'description': 'Post-operative UTI rate'}], 'secondaryOutcomes': [{'measure': 'Assess the types of bacterial uropathogens isolated from the urine cultures', 'timeFrame': 'approximately 4 weeks'}, {'measure': 'Adverse symptoms possibly causes by silver-coated catheter', 'timeFrame': 'approximately 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Silver-coated catheter', 'UTI', 'Pelvic Reconstructive Surgery', 'Urogynecology'], 'conditions': ['UTI']}, 'referencesModule': {'references': [{'pmid': '39744866', 'type': 'DERIVED', 'citation': 'Lewis K, Crisp C, Ray M, Bonglack M, Carrel-Lammert M, Aldrich E, Pauls R, Hoehn J, Yeung J. Silver-Coated Foley Catheters to Reduce UTIs: A Randomized Clinical Trial. Urogynecology (Phila). 2025 Mar 1;31(3):276-284. doi: 10.1097/SPV.0000000000001634. Epub 2025 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery\n\nSecondary Aims:\n\nTo assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.\n\nExclusion Criteria:\n\n* Unwilling or unable to participate in the study.\n* Unwilling or unable to do a catheter self-removal at home.\n* Inability to understand English.\n* Pregnant women\n* Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.\n* Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis\n* Active urinary tract infection.\n* Intraoperative bladder injury or cystotomy\n* Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms\n* Reported allergy to silver metal"}, 'identificationModule': {'nctId': 'NCT05408533', 'briefTitle': 'Silver-Coated vs Standard Catheter for UTI Prevention', 'organization': {'class': 'OTHER', 'fullName': 'TriHealth Inc.'}, 'officialTitle': 'Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '22-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silver-Coated Catheter', 'interventionNames': ['Device: 2-Way Foley Urethral Urinary Catheter']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard Catheter', 'interventionNames': ['Device: 2-Way Foley Urethral Urinary Catheter']}], 'interventions': [{'name': '2-Way Foley Urethral Urinary Catheter', 'type': 'DEVICE', 'description': 'Comparing two types of catheter (silver-coated silicone versus silicone) after Pelvic Reconstructive Surgery (PRS) to compare Urinary Tract Infection (UTI) rates', 'armGroupLabels': ['Silver-Coated Catheter', 'Standard Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Urogynecology Associates', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Good Samaritan Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Jennifer Yeung, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TriHealth Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TriHealth Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}