Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-02 @ 7:10 AM
Study NCT ID:
NCT01559558
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2012-03-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052858', 'term': 'Cystocele'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-19', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-19', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of pad weight and values of urethral pressure profiles after vaginal gauze packing.', 'timeFrame': '1 day', 'description': 'Changes of pad weight and values of urethral pressure profiles between before and after vaginal gauze packing'}], 'secondaryOutcomes': [{'measure': 'The rate of anti-incontinence surgery using the criteria of pad weight > 8 gm after vaginal gauze packing as the indication of concomitant anti-incontinence surgery during cystocele repair', 'timeFrame': '5 years', 'description': 'The rate of anti-incontinence surgery in the follow-up period after cystocele repair using the criteria of pad weight \\> 8 gm after vaginal gauze packing in the initial urodynamic examinations as the indication of concomitant anti-incontinence surgery during cystocele repair.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cystocele']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to retrospectively review the impact of vaginal packing on the urodynamic studies, especially for urethral pressure profiles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with \\>/= stage II cystocle', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with \\>= stage II cystocele and underwent urodynamic studies\n\nExclusion Criteria:\n\n* patients less than 20 patients'}, 'identificationModule': {'nctId': 'NCT01559558', 'briefTitle': 'Changes of Pad Weight Results and Urethral Pressure Profiles After Reduction of Cystocele by Vaginal Gauze Packing', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'orgStudyIdInfo': {'id': '201104016RC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'cystocele', 'interventionNames': ['Procedure: vaginal packing']}], 'interventions': [{'name': 'vaginal packing', 'type': 'PROCEDURE', 'description': 'vaginal packing after urodynamic studies, and repeat urethral pressure profile', 'armGroupLabels': ['cystocele']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ho-Hsiung Lin, Professor of Department of Obstetrics & Gynecology', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}