Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-13 @ 11:01 PM
Study NCT ID:
NCT00571350
Status:
UNKNOWN
Last Update Posted:
2007-12-12
First Post:
2007-12-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anterior Vaginal Wall Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014596', 'term': 'Uterine Prolapse'}, {'id': 'D052858', 'term': 'Cystocele'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital 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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-12-10', 'studyFirstSubmitDate': '2007-12-10', 'studyFirstSubmitQcDate': '2007-12-10', 'lastUpdatePostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.', 'timeFrame': '2008'}], 'secondaryOutcomes': [{'measure': 'GOOD QUALITY OF LIFE FOR PATIENTS', 'timeFrame': '2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cystocele', 'tension free vaginal tapes', 'urinary incontinence'], 'conditions': ['Vaginal Prolapse']}, 'referencesModule': {'references': [{'pmid': '11408853', 'type': 'BACKGROUND', 'citation': 'Sand PK, Koduri S, Lobel RW, Winkler HA, Tomezsko J, Culligan PJ, Goldberg R. Prospective randomized trial of polyglactin 910 mesh to prevent recurrence of cystoceles and rectoceles. Am J Obstet Gynecol. 2001 Jun;184(7):1357-62; discussion 1362-4. doi: 10.1067/mob.2001.115118.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.', 'detailedDescription': 'Objective: The purpose of this study is to assess the effectiveness of the polypropylene tape in preventing cystocele recurrence when placed underneath the bladder base as a concomitant measure to the anterior colporrhaphy procedure.\n\nMethods: Fifty Caucasian women 50 to 77 years old (mean age 66.6 years), 2 pre and 48 post menopausal with stage II-IV pelvic organ prolapse, enrolled into the study. Vaginal reconstructive surgery included an anterior colporrhaphy in all patients, posterior colpoperineorrhaphy in 28 patients and hysterectomy in 36 patients. They were randomly divided in a control group of 22 women and a study group of 28 women. As reinforcement to the anterior colporrhaphy procedure a polypropylene tape (TVT-O) was placed not under the midurethra, as originally described in case of stress incontinence, but underneath the bladder base and was fixed there with polyglactin sutures, in the study group. The postoperative follow up was carried out in frequent intervals of 4 months (total 48 months). The assessment of the anatomic result included evaluation of the operated sites and of the position of the tapes inserted on clinical grounds and after perineal sonography, which measured the distance of the bladder base to the inferior edge of the symphysis pubis.\n\nResults: In all patients the postoperative correction of the anterior vaginal wall was sufficient; the mean distance of the bladder base to the inferior edge of the symphysis pubis was 1.5 cm (range 1.0-2.2 cm). Mean residual urine volume was 30 ml. There were postoperatively 2 cases of stress incontinence and two cases of urge incontinence one in each group. There was no case of tape erosion noted, no dyspareunia and no recurrent cystocele in the study group. Four cases of recurrent cystocele (20%) were reported in our control group.\n\nConclusion: The tension free vaginal tape, particularly TVT-O, placed underneath the bladder base, when performed concomitantly to the anterior colporrhaphy appears to be safe and effective. While the preliminary results of our study are encouraging, larger series of patients and longer follow up are required to verify the effectiveness of the aforementioned modification.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '77 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 50-77 years old with stage II-IV organ prolapse'}, 'identificationModule': {'nctId': 'NCT00571350', 'briefTitle': 'Anterior Vaginal Wall Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Hippocration General Hospital'}, 'officialTitle': 'Anterior Vaginal Wall Reconstruction: Anterior Colporrhaphy Reinforced With Tension Free Vaginal Tape Underneath Bladder Base', 'orgStudyIdInfo': {'id': 'ARISFC'}, 'secondaryIdInfos': [{'id': 'HIPPOKRATIO HOSPITAL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'women with vaginal prolapse who underwent TVT O', 'interventionNames': ['Procedure: tvt-o operation', 'Procedure: tvt o operation']}], 'interventions': [{'name': 'tvt-o operation', 'type': 'PROCEDURE', 'otherNames': ['Johnson & Johnson Ethicon Gyneacare, Somerville, NJ, USA'], 'description': 'transvaginal tention free obturator tape', 'armGroupLabels': ['A']}, {'name': 'tvt o operation', 'type': 'PROCEDURE', 'otherNames': ['tention free vaginal tape'], 'description': 'transobturator vaginal tape insertion', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Medical School Aristotle University', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'ANGELOS DANIILIDIS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIPPOKRATIO UNIVERSITY HOSPITAL'}, {'name': 'JOHN TZAFETTAS, PROFESSOR', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HIPPOKRATIO UNIVERSITY HOSPITAL'}, {'name': 'THEOHARIS TANTANASIS, ASS PROF', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HIPPOKRATIO UNIVERSITY HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hippocration General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': '2nd OBSTETRICS AND GYNECOLOGY UNIVERSITY CLINIC', 'oldOrganization': 'HIPPOKRATIO UNIVERSITY HOSPITAL'}}}}