Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-03-02 @ 8:19 PM
Study NCT ID:
NCT03178734
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Foley Catheter vs a Self-contained Valved Urinary Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055499', 'term': 'Catheter-Related Infections'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'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': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study aim is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter vs a valved catheter in patients who are being discharged home with a catheter after urogynecologic proecures via a Randomized Clinical Trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-26', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-06-05', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of urinary tract infections', 'timeFrame': 'Up to 4 weeks after surgery', 'description': 'Number of urine cultures positive for infection (taken at voiding trial visit and post-operative visit).'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction', 'timeFrame': 'Up to 5 days after surgery', 'description': 'Foley satisfaction questionnaire will be collected at post-operative voiding trial office visit.'}, {'measure': 'Number of days until spontaneous void/Number of calls for device-related issues', 'timeFrame': 'Up to 4 weeks after surgery', 'description': 'Number of days until spontaneous void and number of call for device-related issues.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Catheter-Related Infections', 'Urinary Tract Infections', 'Urogynecologic Surgery']}, 'referencesModule': {'references': [{'pmid': '34184246', 'type': 'DERIVED', 'citation': 'Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial.', 'detailedDescription': 'The purpose of this study is to compare UTI rates and patient satisfaction associated with indwelling Foley catheter verses a valved catheter in patients who are being discharged home with a catheter after urogynecologic procedures via a Randomized Clinical Trial. Total number of participants will be 100. Inclusion criteria is all patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter. Exclusion criteria is intra-operative bladder injury during index surgery; intra-operative complication requiring continuous bladder drainage; and/or dementia/altered cognitive function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients undergoing pelvic reconstructive surgery/anti-incontinence procedures who are planned to be discharged home with a catheter.\n\nExclusion Criteria:\n\n* Intra-operative bladder injury during index surgery\n* Intra-operative complication requiring continuous bladder drainage\n* Dementia / altered cognitive function'}, 'identificationModule': {'nctId': 'NCT03178734', 'briefTitle': 'Foley Catheter vs a Self-contained Valved Urinary Catheter', 'organization': {'class': 'OTHER', 'fullName': 'Atlantic Health System'}, 'officialTitle': 'Foley Catheter vs a Self-contained Valved Urinary Catheter for Patients Who Are Being Discharged Home With a Catheter After Urogynecologic Procedures', 'orgStudyIdInfo': {'id': '908398'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Indwelling Foley Catheter', 'description': 'These patients will have a traditional foley catheter with attached drainage bag (Indwelling Foley Catheter).', 'interventionNames': ['Device: Foley Catheter vs Self-Contained Valved Catheter']}, {'type': 'OTHER', 'label': 'Self-Contained Valved Catheter', 'description': 'These patients will have a BARD Flip Flo Catheter Valve attached to the original foley catheter (Self-Contained Valved Catheter).', 'interventionNames': ['Device: Foley Catheter vs Self-Contained Valved Catheter']}], 'interventions': [{'name': 'Foley Catheter vs Self-Contained Valved Catheter', 'type': 'DEVICE', 'description': 'This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.', 'armGroupLabels': ['Indwelling Foley Catheter', 'Self-Contained Valved Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Atlantic Urogynecology Associates', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}], 'overallOfficials': [{'name': 'Charbel G Salamon, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atlantic Health System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'charbel salamon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Charbel Salamon, MD, MS, FACOG', 'investigatorFullName': 'charbel salamon', 'investigatorAffiliation': 'Atlantic Health System'}}}}