Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-01 @ 10:09 AM
Study NCT ID:
NCT03607968
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2018-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'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': 134}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2018-05-13', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of urodynamic stress incontinence', 'timeFrame': '2011/11/01-2015/12/31', 'description': 'Preoperative and postoperative urodynamic studies to detect USI'}], 'secondaryOutcomes': [{'measure': 'Improvement of stress urinary incontinence', 'timeFrame': '2011/11/01-2015/12/31', 'description': 'Preoperative and postoperative 20-minute pad test changes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pelvic organ prolapse', 'Transvaginal mesh', 'Urodynamic stress incontinence'], 'conditions': ['Concomitant Conditions']}, 'descriptionModule': {'briefSummary': 'Background/Purpose:\n\nA novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.\n\nPatients and Methods:\n\nAll women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \\[i.e., 100 \\* (postoperative pad weight - baseline pad weight)/baseline pad weight\\].\n\nExpected Results:\n\nThe investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery. Key Words: pelvic organ prolapse, stress urinary incontinence, pad test, urodynamic stress incontinence', 'detailedDescription': 'Background/Purpose:\n\nA novel transvaginal mesh (TVM) surgery for women with pelvic organ prolapse (POP) had been reported. However, factors affecting the efficacy of this novel TVM surgery are unknown; and the above information should be important for preoperative consultation, especially for POP women with concomitant urodynamic stress incontinence (USI). Thus, the aim of this study is to investigate the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.\n\nMethods:\n\nAll women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries between November 2011 and December 2015 at the Department of Obstetrics \\& Gynecology, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \\[i.e., 100 \\* (postoperative pad weight - baseline pad weight)/baseline pad weight\\].\n\nExpected Results:\n\nThe investigators will get the factors responsible for anti-incontinence effect of this novel anterior TVM surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female\n* Diagnosed with pelvic organ prolapse and concomitant overt or occult urodynamic stress incontinence\n* Received the novel anterior transvaginal mesh surgery.\n\nExclusion Criteria:\n\n* Pregnant women, prepare for pregnancy or younger than 20-year-old\n* Significant severe urinary urgency\n* Mixed urinary incontinence with dominant urgency incontinence\n* Regular urethral catheterization or intermittent self-catheterization\n* Urinary tract infection (UTI) or chronic inflammation in recent 2 weeks before operation\n* Bladder calculus\n* A history of pelvic radiotherapy\n* Preexisting malignant pelvic tumors.'}, 'identificationModule': {'nctId': 'NCT03607968', 'briefTitle': 'Factors Affecting the Improvement of Severity of Concomitant USI After a Novel TVM Surgery for Women With POP', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Factors Affecting the Improvement of Severity of Concomitant Urodynamic Stress Incontinence After a Novel Transvaginal Mesh Surgery for Women With Pelvic Organ Prolapse', 'orgStudyIdInfo': {'id': '201604022RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All women in this study', 'description': 'All women with POP and concomitant overt or occult USI, who underwent the novel anterior TVM surgeries, were enrolled in this study. Medical records, including urodynamic studies, questionnaires and 3-day bladder diaries, were retrospectively reviewed. Linear regress analysis was used to identify factors that were responsible for the changes in pad weights from baseline \\[i.e., 100 \\* (postoperative pad weight - baseline pad weight)/baseline pad weight\\].', 'interventionNames': ['Procedure: The novel anterior TVM surgeries']}], 'interventions': [{'name': 'The novel anterior TVM surgeries', 'type': 'PROCEDURE', 'description': 'A novel transvaginal mesh (TVM) surgery fro women with pelvic organ prolapse (POP) had been reported. Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical outcomes and urodynamic effects of tailored transvaginal mesh surgery for pelvic organ prolapse. Biomed Res Int http;//dx.doi.org/10.1155/2015/191258.', 'armGroupLabels': ['All women in this study']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'HO-HSIUNG LIN, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Obstetrics and Gynecology, National Taiwan University College of Medicine and Hospital, Taipei, Taiwan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No IPD sharing plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}