Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02739256
Status:
TERMINATED
Last Update Posted:
2018-06-27
First Post:
2016-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Versus Late Voiding Trials After Prolapse Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016055', 'term': 'Urinary Retention'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'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'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'whyStopped': 'Institutional implementation of a same day discharge pathway', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-25', 'studyFirstSubmitDate': '2016-03-10', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to return of normal bladder function', 'timeFrame': '5 days'}], 'secondaryOutcomes': [{'measure': 'time to first ambulation', 'timeFrame': '24 hours'}, {'measure': 'anxiety level', 'timeFrame': '24 hours', 'description': "The State-Trait Anxiety Index anxiety inventory will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter"}, {'measure': 'pain level', 'timeFrame': '24 hours', 'description': "A pain scale will be administered pre-operatively and at 4 different time point post-operatively to assess the patient's level of anxiety related to the catheter"}, {'measure': 'patient preference in the timing of the voiding trial', 'timeFrame': '24 hours', 'description': 'a brief survey will be given 4 times during the hospital admission assess this'}, {'measure': 'catheter associated urinary tract infections', 'timeFrame': '6 weeks', 'description': 'medical records will be reviewed after discharge from the hospital for positive urine cultures'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['voiding trial', 'pelvic organ prolapse', 'post-operative catheterization'], 'conditions': ['Urinary Retention', 'Pelvic Organ Prolapse']}, 'referencesModule': {'references': [{'pmid': '22752014', 'type': 'RESULT', 'citation': 'Oliphant SS, Lowder JL, Ghetti C, Zyczynski HM. Effect of a preoperative self-catheterization video on anxiety: a randomized controlled trial. Int Urogynecol J. 2013 Mar;24(3):419-24. doi: 10.1007/s00192-012-1868-y. Epub 2012 Jul 3.'}, {'pmid': '21860294', 'type': 'RESULT', 'citation': 'Geller EJ, Hankins KJ, Parnell BA, Robinson BL, Dunivan GC. Diagnostic accuracy of retrograde and spontaneous voiding trials for postoperative voiding dysfunction: a randomized controlled trial. Obstet Gynecol. 2011 Sep;118(3):637-642. doi: 10.1097/AOG.0b013e318229e8dd.'}, {'pmid': '25185611', 'type': 'RESULT', 'citation': 'Turner LC, Kantartzis K, Shepherd JP. Predictors of postoperative acute urinary retention in women undergoing minimally invasive sacral colpopexy. Female Pelvic Med Reconstr Surg. 2015 Jan-Feb;21(1):39-42. doi: 10.1097/SPV.0000000000000110.'}, {'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 primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. Half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.', 'detailedDescription': 'Overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. A voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. A significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux.\n\nThis study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. An earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. Additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). To date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* surgical management of pelvic organ prolapse requiring an overnight hospital admission\n\nExclusion Criteria:\n\n* same day surgery\n* non-ambulatory (allowed to use an assistive device)\n* inability to provide informed consent, age \\< 21 years\n* pregnancy or desire for future pregnancy\n* systematic disease known to affect bladder function (Parkinson's disease, Multiple Sclerosis, Spina Bifida, spinal cord injury or trauma and neurogenic bladder)\n* known preoperative urinary retention (defined as a post-void residual \\> 100mL)\n* an untreated urinary tract infection at the time of surgery\n* treatment at the time of surgery for urinary tract infection\n* symptoms of urinary tract infection on the day of surgery"}, 'identificationModule': {'nctId': 'NCT02739256', 'briefTitle': 'Early Versus Late Voiding Trials After Prolapse Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Normal Voiding Function After Surgical Repair of Pelvic Organ Prolapse: A Randomized Trial Comparing Day of Surgery Retrograde Void Trials to Standard Postoperative Day One Retrograde Void Trials', 'orgStudyIdInfo': {'id': 'PRO15100653'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'voiding trial 4 hours post-op', 'interventionNames': ['Procedure: Retrograde voiding trial']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'voiding trial post-op day 1', 'interventionNames': ['Procedure: Retrograde voiding trial']}], 'interventions': [{'name': 'Retrograde voiding trial', 'type': 'PROCEDURE', 'otherNames': ['Bladder Test'], 'description': 'A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.', 'armGroupLabels': ['voiding trial 4 hours post-op', 'voiding trial post-op day 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Magee Women's Hospital of UPMC", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Charelle Carter-Brooks, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urogynecology Fellow'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Charelle Carter-Brooks', 'investigatorAffiliation': 'University of Pittsburgh'}}}}