Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-28 @ 6:07 AM
Study NCT ID:
NCT00743535
Status:
TERMINATED
Last Update Posted:
2013-04-08
First Post:
2008-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052858', 'term': 'Cystocele'}, {'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D011391', 'term': 'Prolapse'}], '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': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'Low recruitment rate.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-05', 'studyFirstSubmitDate': '2008-08-28', 'studyFirstSubmitQcDate': '2008-08-28', 'lastUpdatePostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective/subjective symptoms improvements', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Intra-operative complication rate', 'timeFrame': 'one day'}, {'measure': 'Postoperative complications rate', 'timeFrame': '12 months'}, {'measure': 'Failure rate', 'timeFrame': '12 months'}, {'measure': 'Recurrence rate', 'timeFrame': '12 months'}, {'measure': 'Quality of life', 'timeFrame': '12 months'}, {'measure': 'Sexual function', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Cystocele', 'Mesh', 'Prolapse', 'Sling', 'Stress incontinence', 'Surgery', 'TOT', 'TVT', 'Treatment'], 'conditions': ['Cystocele', 'Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The incidence of anterior pelvic defect in women is estimated about 10% and it may be often associated to urinary stress incontinence. To date the correction of anterior defects with the use of graft material inserted with transobturator approach has become of large use. Moreover, given the frequent association of urinary stress incontinence to anterior defect, in most of cases it becomes necessary to perform at the same time an anti-incontinence procedure, i.e. a sub-urethral sling positioning. Based on these considerations the aim of this trial will be to compare two different approach for sub-urethral sling positioning, transobturator and transvaginal tape (TOT and TVT) performed in association to transobturator correction of anterior defect with mesh in terms of efficacy and safety.', 'detailedDescription': 'Women with anterior defect and genuine stress urinary incontinence will be enrolled and randomized in two groups (arm 1 and 2). All patients will be treated with a transobturator correction of anterior defect, in patients of arm 1 will be associated TOT, whereas in patients of arm 2 will be associated TVT.\n\nAll patients eligible will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.\n\nData will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cystocele\n* Genuine stress urinary incontinence by self report, examination and test\n* Urethral hypermobility\n* Eligible for both surgical procedures\n* Ambulatory\n\nExclusion Criteria:\n\n* Pregnancy\n* \\<12 months post-partum\n* Systemic disease and/or drugs known to affect bladder function\n* Current chemotherapy or radiation therapy\n* Urethral diverticulum, augmentation cytoplasty, or artificial sphincter\n* Recent pelvic surgery\n* Previous pelvic or anti-incontinence surgery\n* History of severe abdominopelvic infections\n* Known extensive abdominopelvic adhesions\n* Detrusor instability and/or intrinsic sphincter dysfunction\n* Other gynaecologic pathologies (eg, fibroids, ovarian cysts)\n* BMI \\>30'}, 'identificationModule': {'nctId': 'NCT00743535', 'briefTitle': 'Anterior Defect Correction With Mesh Plus Treatment of Stress Incontinence With Transobturator or Transvaginal Approach', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'A Comparison in Terms of Efficacy and Safety Between Transobturator and Transvaginal Tape Performed at the Same Time of Anterior Defect Correction With Mesh', 'orgStudyIdInfo': {'id': '03/2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Transobturatory correction of anterior defect plus TOT', 'interventionNames': ['Procedure: Transobturatory correction of anterior defect plus TOT']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage.\n\nSmall incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle.', 'interventionNames': ['Procedure: Transobturatory correction of anterior defect plus TVT']}], 'interventions': [{'name': 'Transobturatory correction of anterior defect plus TOT', 'type': 'PROCEDURE', 'description': 'Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage.\n\nSmall incision sites in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of mono-use needle', 'armGroupLabels': ['1']}, {'name': 'Transobturatory correction of anterior defect plus TVT', 'type': 'PROCEDURE', 'description': 'Longitudinal vaginal incision 1 cm far from esternal urethral meatus. Bladder dissecting and identification of ischiatic spines. Bilateral transobturator insertion of anterior mesh through high and low trans-obturatory approach. Mesh anchorage.\n\nSmall incision sites at sovrapubic level. Bilateral retropubic insertion of mesh by means of mono-use needle.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88100', 'city': 'Catanzaro', 'state': 'Catanzaro', 'country': 'Italy', 'facility': '"Pugliese" Hospital', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Stefano Palomba, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro'}, {'name': 'Fulvio Zullo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair of Obstetrics and Gynecology, University "Magna Graecia" of Catanzaro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Magna Graecia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefano Palomba', 'investigatorAffiliation': 'University Magna Graecia'}}}}