Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:02 PM
Study NCT ID:
NCT04859660
Status:
COMPLETED
Last Update Posted:
2024-02-29
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy
Sponsor:
Organization:
Raw JSON
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Patients needed to void at least 100cc to be considered to have "passed" their void trial.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Discharge From the Post-anesthesia Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tamsulosin- Intervention Group', 'description': 'Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Placebo arm: Participants will be given Placebo the pre-op bay.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '8 weeks', 'description': 'The time from the patient leaving the OR to the time they were discharged home from the Post-anesthesia care unit was recorded to determine the Time to discharge.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tamsulosin- Intervention Group', 'description': 'Tamsulosin arm: Participants will receive a single dose of 0.4mg oral Tamsulosin capsule in the pre-op bay 1-2 hours before surgery.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Placebo arm: Participants will receive a single dose of oral placebo capsule in the pre-op bay 1-2 hours before surgery.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tamsulosin- Intervention Group', 'description': 'Tamsulosin arm: Participants will be given Tamsulosin in the pre-op bay'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Placebo arm: Participants will be given Placebo the pre-op bay.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '46'}, {'value': '42', 'groupId': 'BG001', 'lowerLimit': '35', 'upperLimit': '45'}, {'value': '41', 'groupId': 'BG002', 'lowerLimit': '34', 'upperLimit': '45'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '38'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '26', 'upperLimit': '37'}, {'value': '30', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '38'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Current smoker', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Living births', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Charston Comorbidity index', 'classes': [{'categories': [{'title': 'Score 0 (no health conditions)', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'Score 1', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Score 2', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Score 3', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Score 4 (several health conditions)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-19', 'size': 109273, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-02T16:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2021-04-20', 'resultsFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2021-04-23', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-02', 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Spontaneous Void', 'timeFrame': '8 weeks', 'description': 'Each participant underwent a void trial post-operatively by backfilling their bladder with 200cc normal saline at the conclusion of the case and removing the foley. Patients needed to void at least 100cc to be considered to have "passed" their void trial.'}], 'secondaryOutcomes': [{'measure': 'Time to Discharge From the Post-anesthesia Care Unit', 'timeFrame': '8 weeks', 'description': 'The time from the patient leaving the OR to the time they were discharged home from the Post-anesthesia care unit was recorded to determine the Time to discharge.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Retention Postoperative']}, 'referencesModule': {'references': [{'pmid': '39265173', 'type': 'DERIVED', 'citation': 'Gabra M, Hall C, McCann L, Shah J, Jones I, Masjedi A, Runke S, Hsu CH, Aguirre A. Tamsulosin and Time to Spontaneous Void After Hysterectomy: A Randomized Controlled Trial. Obstet Gynecol. 2024 Dec 1;144(6):810-816. doi: 10.1097/AOG.0000000000005724. Epub 2024 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if a one time dose of tamsulosin given pre-operatively decreases the time to void and the time to discharge after minimally invasive hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18-80 undergoing outpatient minimally invasive hysterectomy\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Bladder malignancy\n* Intra-operative bladder or ureteral injury; anticipated prolonged bladder catheterization\n* Plan for sling or anterior repair'}, 'identificationModule': {'nctId': 'NCT04859660', 'briefTitle': 'Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'Pre-operative Tamsulosin After Minimally Invasive Hysterectomy and Time to Spontaneous Void: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2102483026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tamsulosin- intervention group', 'interventionNames': ['Drug: Tamsulosin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tamsulosin', 'type': 'DRUG', 'description': 'Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.', 'armGroupLabels': ['Tamsulosin- intervention group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center- Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center- Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}