Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-29 @ 12:12 PM
Study NCT ID:
NCT04412928
Status:
COMPLETED
Last Update Posted:
2023-09-15
First Post:
2020-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 591}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-14', 'studyFirstSubmitDate': '2020-05-31', 'studyFirstSubmitQcDate': '2020-05-31', 'lastUpdatePostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Factors affecting the presence of overactive bladder syndrome after mid-urethral sling procedure', 'timeFrame': '10 year'}], 'secondaryOutcomes': [{'measure': 'Factors affecting cure of overactive bladder syndrome after mid-urethral sling procedure', 'timeFrame': '10 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors.', 'detailedDescription': 'At present, around 30% of women with stress urinary incontinence have overactive bladder syndrome after mid-urethral sling procedure. But its predictive factor is still unclear. We will estimate the incidence of patients with overactive bladder syndrome after surgery and explore related predictors. In addition, we will explore the cure rate and predictors of cure of overactive bladder syndrome after the mid-urethral sling procedure for women with stress urinary incontinence. The above results will be used as a reference for preoperative and postoperative consultation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All women with stress urinary incontinence who underwent mid-urethral sling procedure.', 'genderDescription': 'women with stress urinary incontinence', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women with stress urinary incontinence who underwent mid-urethral sling procedure from January 01, 2008 to July 31, 2019 will be reviewed.\n\nExclusion Criteria:\n\n* Patients undergoing other gynecological operations at the same time, except for cystoscopy.'}, 'identificationModule': {'nctId': 'NCT04412928', 'briefTitle': 'Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Factors Affecting the Cure of Overactive Bladder Syndrome in Women Underwent Mid-urethral Sling Procedure', 'orgStudyIdInfo': {'id': '109048-E'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mid-urethral sling procedure', 'type': 'PROCEDURE', 'description': 'mid-urethral sling procedure'}]}, 'contactsLocationsModule': {'locations': [{'zip': '22050', 'city': 'Banqiao District', 'state': 'New Taipei', 'country': 'Taiwan', 'facility': 'Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Department of Obstetrics & Gynecology, Associate Professor', 'investigatorFullName': 'Sheng-Mou Hsiao', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}