Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:14 AM
Study NCT ID:
NCT03809806
Status:
COMPLETED
Last Update Posted:
2019-01-18
First Post:
2019-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Four-arm Mesh for Vaginal Stump Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients with vaginal stump prolapse who had undergone hysterectomy in the past'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-17', 'studyFirstSubmitDate': '2019-01-16', 'studyFirstSubmitQcDate': '2019-01-17', 'lastUpdatePostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pelvic Organ Prolapse Quantification (POPQ) 1 year after procedure', 'timeFrame': '1 year', 'description': 'assessment of POPQ 1 year after mesh operation, Pelvic Organ Prolapse Quantification system (POP-Q) refers to an objective, site-specific system for describing, quantifying, and staging pelvic support in women. It provides a standardized tool for documenting, comparing, and communicating clinical findings with proven interobserver and intraobserver reliability'}], 'secondaryOutcomes': [{'measure': 'Sexual function 1 year after procedure', 'timeFrame': '1 year', 'description': 'assessment of sexual function before and 1 year after the procedure with the use of The Female Sexual Function Index questionnaire'}, {'measure': 'Urinary incontinence 1 year after procedure', 'timeFrame': '1 year', 'description': 'assessment of urinary incontinence before and 1 year after the procedure with the use of the Urogenital Distress Inventory (UDI 6) and the Incontinence Impact Questionnaire (IIQ 7) questionnaire'}, {'measure': 'quality of life 1 year after procedure', 'timeFrame': '1 year', 'description': 'assessment of quality of life before and 1 year after the procedure with the use of The Short Form Health Survey (SF 36)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vaginal stump prolapse', 'sexual function', 'quality of life'], 'conditions': ['Pelvic Organ Prolapse', 'Sexual Function Abnormal']}, 'descriptionModule': {'briefSummary': 'To estimate the safety and efficacy of performing modified anterior transvaginal mesh surgery using polypropylene mesh for treatment of advanced urogenital prolapse after hysterectomy (stage III and IV vc Pelvic Organ Prolapse Quantification \\[POP-Q\\] system staging).', 'detailedDescription': 'Pelvic reconstructive procedures were primarily performed using the transvaginal four arm polypropylene mesh, which was inserted through: upper arms- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments. All patients underwent hysterectomy in the past apart from one which underwent vaginal hysterectomy during the procedure. Perineoplasty was performed additionally, if indicated. Subjective and objective evaluations included Pelvic Organ Prolapse Quantification \\[POP-Q\\] staging, preoperative and 1-year postoperative questionnaires were performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pelvic Organ Prolapse Quantification (POPQ) III and IV vc after hysterectomy\n\nExclusion Criteria:\n\n* malignant diseases\n* unability to understand informed consent'}, 'identificationModule': {'nctId': 'NCT03809806', 'briefTitle': 'Four-arm Mesh for Vaginal Stump Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lublin'}, 'officialTitle': 'Four-arm Mesh for Vaginal Stump Prolapse: Surgical Technique and Outcomes', 'orgStudyIdInfo': {'id': '02/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patients after hysterectomy', 'description': 'modified anterior transvaginal mesh surgery', 'interventionNames': ['Procedure: 4-arm polypropylene mesh surgery', 'Diagnostic Test: The Female Sexual Function Index (FSFI) questionnaire', 'Diagnostic Test: King Health Questionnaire (KHQ)', 'Diagnostic Test: Pelvic Organ Prolapse Quantification (POPQ) staging', 'Diagnostic Test: Postoperative questionnaire', 'Diagnostic Test: The Short Form Health Survey (SF 36) questionnaire']}], 'interventions': [{'name': '4-arm polypropylene mesh surgery', 'type': 'PROCEDURE', 'description': 'Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.', 'armGroupLabels': ['patients after hysterectomy']}, {'name': 'The Female Sexual Function Index (FSFI) questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients fulfilled questionnaire before and 1 year after procedure', 'armGroupLabels': ['patients after hysterectomy']}, {'name': 'King Health Questionnaire (KHQ)', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients fulfilled questionnaire before and 1 year after procedure', 'armGroupLabels': ['patients after hysterectomy']}, {'name': 'Pelvic Organ Prolapse Quantification (POPQ) staging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Pelvic Organ Prolapse staging before and 1 year after the procedure', 'armGroupLabels': ['patients after hysterectomy']}, {'name': 'Postoperative questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure', 'armGroupLabels': ['patients after hysterectomy']}, {'name': 'The Short Form Health Survey (SF 36) questionnaire', 'type': 'DIAGNOSTIC_TEST', 'description': 'patients fulfilled questionnaire before and 1 year after procedure', 'armGroupLabels': ['patients after hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20-954', 'city': 'Lublin', 'country': 'Poland', 'facility': '2nd Gynecology Department', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}], 'overallOfficials': [{'name': 'Tomasz Rechberger, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': '2nd Gynecology Department Medical University in Lublin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lublin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Paweł Miotła', 'investigatorAffiliation': 'Medical University of Lublin'}}}}