Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05885958
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2023-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Timing of Active Void Trials After Urogynecologic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013995', 'term': 'Time'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 231}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-26', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-05-22', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pass Rate', 'timeFrame': '60 minutes', 'description': 'to compare the active void trial pass rate between arms'}], 'secondaryOutcomes': [{'measure': 'Time in PACU', 'timeFrame': '6 hours', 'description': 'to compare overall time spent in the PACU between arms'}, {'measure': 'Pass Rate After Failing', 'timeFrame': '60 minutes', 'description': 'to assess the overall pass rate of active void trial after failed first attempt'}, {'measure': 'UTI', 'timeFrame': '2 weeks', 'description': 'to assess rate of urinary tract infection after surgery'}, {'measure': 'Surgical Procedures Performed Prior to Active Void Trial', 'timeFrame': '2 years', 'description': 'to compare types of surgery women are having with the rate of void trial passing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Care', 'Urinary Catheters', 'Urogynecology']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Barber MD, Walters MD, Karram MM, et al. Walters & Karram Urogynecology and Reconstructive Pelvic Surgery - E-Book: Elsevier Health Sciences; 2021'}, {'pmid': '27647467', 'type': 'BACKGROUND', 'citation': 'Lo TS, Shailaja N, Hsieh WC, Uy-Patrimonio MC, Yusoff FM, Ibrahim R. Predictors of voiding dysfunction following extensive vaginal pelvic reconstructive surgery. Int Urogynecol J. 2017 Apr;28(4):575-582. doi: 10.1007/s00192-016-3144-z. Epub 2016 Sep 19.'}, {'pmid': '22500251', 'type': 'BACKGROUND', 'citation': 'Kim JW, Moon du G, Shin JH, Bae JH, Lee JG, Oh MM. Predictors of Voiding Dysfunction after Mid-urethral Sling Surgery for Stress Urinary Incontinence. Int Neurourol J. 2012 Mar;16(1):30-6. doi: 10.5213/inj.2012.16.1.30. Epub 2012 Mar 31.'}, {'pmid': '31732771', 'type': 'BACKGROUND', 'citation': 'Mills JT, Rapp DE, Shaw NM, Hougen HY, Agard HE, Case RM Jr, McMurry TL, Schenkman NS, Krupski TL. Effect of active versus passive void trials on time to patient discharge, urinary tract infection, and urinary retention: a randomized clinical trial. World J Urol. 2020 Sep;38(9):2247-2252. doi: 10.1007/s00345-019-03005-0. Epub 2019 Nov 15.'}, {'pmid': '26886553', 'type': 'BACKGROUND', 'citation': 'Wang R, Won S, Haviland MJ, Von Bargen E, Hacker MR, Li J, Lefevre R. Voiding trial outcome following pelvic floor repair without incontinence procedures. Int Urogynecol J. 2016 Aug;27(8):1215-20. doi: 10.1007/s00192-016-2975-y. Epub 2016 Feb 17.'}, {'pmid': '26894607', 'type': 'BACKGROUND', 'citation': 'Barr SA, Thomas A, Potter S, Melick CF, Gavard JA, McLennan MT. Incidence of successful voiding and predictors of early voiding dysfunction after retropubic sling. Int Urogynecol J. 2016 Aug;27(8):1209-14. doi: 10.1007/s00192-016-2972-1. Epub 2016 Feb 19.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn about active void trial pass rates in patients undergoing urogynecologic surgery. The main question it aims to answer is the comparison in pass rate during active void trial between women who are given 30 minutes versus 60 minutes to void following urogynecologic surgery.\n\nPatient will be randomized to two arms prior to scheduled surgery. During the active void trial, women will be allotted up to 30 minutes or up to 60 minutes to void depending on respective randomization.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing a urogynecologic surgery at Tampa General Hospital and who are seen preoperatively at the University of South Florid Urogynecology clinic\n* Women undergoing a urogynecologic surgery where a postoperative active void trial is indicated\n* Planned for same day surgery\n* Women able to consent for themselves\n* Speak English and/or Spanish as preferred language\n\nExclusion Criteria:\n\n* Imprisoned patients\n* Females under the age of 18 years old\n* Women who are unable or unwilling to consent to participation\n* Women who are planning to stay inpatient overnight\n* Women with history of urinary retention or neurogenic bladder\n* Women undergoing procedure that is not standard of care to perform a void trial (includes sacral neuromodulation, botox to the pelvic floor, cystoscopy with hydrodistension, urethral bulking, etc)'}, 'identificationModule': {'nctId': 'NCT05885958', 'briefTitle': 'Timing of Active Void Trials After Urogynecologic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Timing of Active Void Trials After Urogynecologic Procedures', 'orgStudyIdInfo': {'id': 'STUDY005629'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate', 'description': 'Patients will be given up to 30 minutes to void during the active void trial postoperatively.', 'interventionNames': ['Other: Time']}, {'type': 'EXPERIMENTAL', 'label': 'Extended', 'description': 'Patients will be given up to 60 minutes to void during the active void trial postoperatively.', 'interventionNames': ['Other: Time']}], 'interventions': [{'name': 'Time', 'type': 'OTHER', 'description': 'Patients will be given up to 30 minutes to void.', 'armGroupLabels': ['Immediate']}, {'name': 'Time', 'type': 'OTHER', 'description': 'Patients will be given up to 60 minutes to void.', 'armGroupLabels': ['Extended']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Urogynecology Clinic', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Simone Fertel', 'investigatorAffiliation': 'University of South Florida'}}}}