Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 11:30 PM
Study NCT ID:
NCT04829994
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2021-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Market Clinical Follow-Up onTVT EXACT® Continence System
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2036-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2021-03-17', 'studyFirstSubmitQcDate': '2021-03-31', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cough Stress Test (CST) Assessment Change', 'timeFrame': 'Post-surgery through study completion, approximately 5-10 yrs', 'description': 'Objective cure of Stress Urinary Incontinence (SUI) (treatment success) sproximately 5-10 years after surgery, defined as a negative CST'}], 'secondaryOutcomes': [{'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': 'Post-surgery through study completion, approximately 10 yrs'}, {'measure': 'International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)', 'timeFrame': 'Baseline and post-surgery through study completion, approximately 10 yrs'}, {'measure': 'Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)', 'timeFrame': 'Baseline and post-surgery through study, approximately 10 yrs completion'}, {'measure': 'Wong-Baker FACES® Pain Rating Scale', 'timeFrame': 'Post-surgery through study completion, approximately 10 yrs', 'description': 'To assess pain on a scale from 0 (no pain) to 10 (worst pain) related to study device or procedure'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['GYNECARE TVT EXACT® Continence System', 'SUI'], 'conditions': ['Stress Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'The objective of this single arm, post market, clinical study is to evaluate the performance of Gynecare TVT EXACT® Continence System in women undergoing retropubic mid-urethral sling surgery for Stress Urinary Incontinence (SUI).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female subjects ≥ 21 years of age with a diagnosis of SUI, resulting from utrethral hypermobility and/or intrinsic sphincter deficiency.', 'genderDescription': 'Female subjects ≥ 21 years of age', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nSubjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:\n\n1. Stress urinary incontinence symptoms\n2. Stress urinary incontinence confirmed by diagnostic evaluation of a cough stress test\n3. Female subjects ≥ 21 years of age requiring treatment of SUI\n4. Desired surgical correction of stress urinary incontinence using a synthetic pubo-urethral vaginal sling\n5. Planned surgery for primary stress incontinence without concomitant prolapse surgery\n6. Patient able and willing to participate in follow-up\n7. Subject or authorized representative has signed the approved informed consent\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be considered not eligible for enrollment in this study:\n\n1. Physical or psychological condition which would impair study participation or are unwilling or unable to participate in all required study visits and are unable to complete the questionnaires\n2. Any pre-operative or intra-operative findings identified by the surgeon that may preclude the use of study product\n3. History of previous synthetic, biologic or fascial pubo-urethral sling\n4. Pregnancy or plans for future pregnancy\n5. History of bleeding diathesis or current anti-coagulation therapy which cannot be suspended peri-operatively according to site's standard practice.\n6. Current genitourinary fistula or urethral diverticulum\n7. Reversible cause of incontinence (i.e. drug effect)\n8. Contraindication to surgery"}, 'identificationModule': {'nctId': 'NCT04829994', 'briefTitle': 'Post-Market Clinical Follow-Up onTVT EXACT® Continence System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Long Term Prospective Post Market Clinical Follow-up (PMCF) of the GYNECARE TVT EXACT® Continence System for the Treatment of Stress Urinary Incontinence', 'orgStudyIdInfo': {'id': 'ESC_2020_05'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intervention', 'type': 'DEVICE', 'description': 'There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures subjects would receive as part of SOC.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27707', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '19454', 'city': 'North Wales', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Institute for Female Pelvic Medicine', 'geoPoint': {'lat': 40.21094, 'lon': -75.27823}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'city': 'Hillerød', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}, {'city': 'Lille', 'country': 'France', 'facility': 'Hopital Jeanne de Flandres', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitatsklinikum Tubingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Martin Weisberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon, Inc.'}]}, 'ipdSharingStatementModule': {'url': 'http://yoda.yale.edu', 'ipdSharing': 'YES', 'description': 'Johnson \\& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}