Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2026-01-01 @ 3:44 PM
Study NCT ID:
NCT04309032
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2020-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction
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': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-12', 'studyFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2020-03-12', 'lastUpdatePostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to void', 'timeFrame': '1day', 'description': 'time from foley catheter removal to actual initial voiding'}, {'measure': 'Time to discharge', 'timeFrame': '1day', 'description': 'time from foley catheter removal to actual discharge'}, {'measure': 'Medical staff satisfaction', 'timeFrame': '1year', 'description': 'Medical staff satisfaction discomfort/satisfaction with overall process based on a Likert scale (5)'}, {'measure': 'Patient satisfaction', 'timeFrame': '1day', 'description': 'patient discomfort/satisfaction with overall process based on a Likert scale (5)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retrograde Bladder Fill']}, 'descriptionModule': {'briefSummary': 'This study is a randomized controlled trial on the effect of retrograde partial bladder fill on time to discharge in patients who have had urological surgery for BPH, and whether it affects overall medical staff satisfaction.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any male patient between ages 20-80 with foley catheter indwelled after urological surgery performed at our institution\n\nExclusion Criteria:\n\n* Any patient that does not remove foley catheter at discharge'}, 'identificationModule': {'nctId': 'NCT04309032', 'briefTitle': 'A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Randomized Controlled Trial on the Effect of Retrograde Partial Bladder Fill on Time to Discharge and Overall Medical Staff Satisfaction', 'orgStudyIdInfo': {'id': 'B-1806-474-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bladder fill', 'description': 'Retrograde bladder filling of 250cc of 0.9% normal saline for irrigation prior to removal of foley catheter', 'interventionNames': ['Procedure: retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter']}, {'type': 'NO_INTERVENTION', 'label': 'No bladder Fill', 'description': 'no filling prior to removal of foley catheter'}], 'interventions': [{'name': 'retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter', 'type': 'PROCEDURE', 'description': '0.9% NS 250cc was introduced before foley catheter removed for discharge', 'armGroupLabels': ['Bladder fill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13620', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'overallOfficials': [{'name': 'Hakmin Lee, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Bundang Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Hakmin Lee', 'investigatorAffiliation': 'Seoul National University Bundang Hospital'}}}}