Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-03-05 @ 12:53 PM
Study NCT ID:
NCT00573703
Status:
WITHDRAWN
Last Update Posted:
2013-04-08
First Post:
2007-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence
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': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'lastUpdateSubmitDate': '2013-04-05', 'studyFirstSubmitDate': '2007-12-12', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2013-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopic Burch colposuspension', 'Stress incontinence', 'Surgery', 'TOT', 'Treatment', 'Predominant or genuine stress urinary incontinence'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'Transobturatory tape (TOT) procedure is a minimally invasive approach to urinary stress incontinence owing to the category of the sling-adopting procedures. Its efficacy and safety, also in comparison with similar procedures have been demonstrated. The benefits of the sling- adopting procedures in comparison to laparoscopic Burch colposuspension, which has been considered as the gold standard treatment, have been showed. But these comparisons did not included the TOT procedure in the experimental arms. Based on this considerations the aim of this trial will be to compare TOT and laparoscopic Burch colposuspension in women with urinary stress incontinence.', 'detailedDescription': 'Women with predominant and genuine stress urinary incontinence will be enrolled and randomized in two groups (groups A and B). Patients of group A will be treated with laparoscopic Burch colposuspension, whereas patients of group B will be treated with TOT procedure.\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* Predominant or 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* Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree\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': 'NCT00573703', 'briefTitle': 'Laparoscopic Burch Colposuspension Versus Transobturatory Tape for the Treatment of Female Urinary Stress Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University Magna Graecia'}, 'officialTitle': 'A Comparison Between Laparoscopic Burch Colposuspension and Transobturatory Tape (TOT) for the Treatment of Female Urinary Stress Incontinence', 'orgStudyIdInfo': {'id': '02/2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'interventionNames': ['Procedure: Laparoscopic Burch colposuspension']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Procedure: Transobturator tape procedure']}], 'interventions': [{'name': 'Laparoscopic Burch colposuspension', 'type': 'PROCEDURE', 'description': "Lapaparoscopic approach. One or two nonadsorbable sutures are placed at the level of the midurethra without penetrating the vaginal mucosa and fixed to Cooper's ligament with a tension free knotting technique.", 'armGroupLabels': ['Group A']}, {'name': 'Transobturator tape procedure', 'type': 'PROCEDURE', 'description': 'Small incision sites in the vagina and in the femoral/pelvic fold. Bilateral transobturator insertion of mesh by means of needle. Application of resorbable tensioning suture that maintains the mesh and enables fine adjustments in mesh tension during the procedure and in the immediate postoperative period.', 'armGroupLabels': ['Group B']}]}, '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'}}}}