Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-06-03 @ 2:36 PM
Study NCT ID:
NCT02886520
Status:
COMPLETED
Last Update Posted:
2019-07-26
First Post:
2016-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}, {'id': 'D014549', 'term': 'Urinary Incontinence'}], 'ancestors': [{'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': 286}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-25', 'studyFirstSubmitDate': '2016-08-27', 'studyFirstSubmitQcDate': '2016-08-27', 'lastUpdatePostDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in subjective questionnaires of incontinence severity', 'timeFrame': 'One year', 'description': 'Change in the punctuation of the following questionnaires comparing before surgery and one year after operation:\n\n* International consultation on Incontinence Urinary Questionnaire-Short Form (ICIQ-SF).\n* Sandvik severity index.'}], 'primaryOutcomes': [{'measure': 'Effectiveness', 'timeFrame': 'One year', 'description': 'Percentage of patients who are regarded as cured or improved one-year after surgery with both techniques based on the following criteria:\n\n* CURED: negative cough stress test and patient must be fully satisfied with the operation (no leaks, no voiding dysfunction, and no use of urinary protection); Patient Global Impresison of Improvement (PGI-I) scale must be "Very much better".\n* IMPROVED: cough stress test had to be negative and the patient moderately satisfied with the result of surgery due to an increase in urinary frequency and/or sporadic urgency episodes; PGI-I must be "Much better" or "A little better".'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'Up to one year.', 'description': 'Comparison of the intra- and postoperative complications between both procedures.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Urinary incontinence', 'Materials', 'Surgery', 'Transobturator tape', 'Polyvinylidene fluoride', 'Polypropylene'], 'conditions': ['Urinary Stress Incontinence']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness and complications of polyvinylidene fluoride (PVDF) and polypropylene (PP) transobturator suburethral tapes (TOTs) in the treatment of female stress urinary incontinence. Half of participants will be operated with PVDF-TOTs, while the other half will be operated with PP ones.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with stress urinary incontinence.\n* Women with stress-predominant mixed urinary incontinence.\n\nExclusion Criteria:\n\n* Incapacity to understand the information or give their consent.\n* Previous anti-incontinence surgery with slings.\n* Low pressure urethra (MUCP \\< 20cmH2O).\n* Neurogenic bladder.'}, 'identificationModule': {'nctId': 'NCT02886520', 'briefTitle': 'Comparative Study of PDVF and Polypropylene Transobturator Suburethral Tapes', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Multicentric Randomized Clinical Trial Comparing Polyvinylidene Fluoride and Polypropylene Transobturator Suburethral Tapes in the Treatment of Female Stress Urinary Incontinence.', 'orgStudyIdInfo': {'id': 'PR(AMI)241-2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PVDF transobturator tape', 'description': 'Transobturator tension-free suburethral tape made of polyvinylidene fluoride.', 'interventionNames': ['Device: PVDF transobturator tape']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PP transobturator tape', 'description': 'Transobturator tension-free suburethral tape made of polypropylene.', 'interventionNames': ['Device: Polypropylene transobturator tape']}], 'interventions': [{'name': 'PVDF transobturator tape', 'type': 'DEVICE', 'otherNames': ['Dynamesh-SIS'], 'armGroupLabels': ['PVDF transobturator tape']}, {'name': 'Polypropylene transobturator tape', 'type': 'DEVICE', 'armGroupLabels': ['PP transobturator tape']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Mataró', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de Viladecans', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital General de Granollers', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Girona', 'country': 'Spain', 'facility': 'Hospital Santa Caterina', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'city': 'Huelva', 'country': 'Spain', 'facility': 'Hospital General Riotinto', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Quiron Sagrado Corazon', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital de Granollers', 'class': 'OTHER'}, {'name': 'Hospital Quiron Sagrado Corazon', 'class': 'OTHER'}, {'name': 'Hospital de Mataró', 'class': 'OTHER'}, {'name': 'Hospital Riotinto', 'class': 'UNKNOWN'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Universitari de Bellvitge', 'class': 'OTHER'}, {'name': 'Hospital de Viladecans', 'class': 'OTHER'}, {'name': 'Hospital Santa Caterina', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}