Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT04935918
Status:
RECRUITING
Last Update Posted:
2021-06-23
First Post:
2021-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001746', 'term': 'Bladder Exstrophy'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2028-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight', 'timeFrame': '24 months', 'description': 'Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in 24 hour Pad weight at 6, 12 and 24 months follow-up compared to the pad weight results at baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of pads per day (voiding diary)', 'timeFrame': '6, 12 and 24 months', 'description': 'Change of number of peds changed per day from baseline to 6, 12 and 24 months (the best : 0 pads changed a day).'}, {'measure': 'Number of incontinence episodes per day (voiding diary)', 'timeFrame': '6, 12 and 24 months', 'description': 'Change in number of incontinence episodes per day from baseline to 6, 12 and 24 months (the best : 0)'}, {'measure': 'PIN-Q questionnaire', 'timeFrame': '6, 12 and 24 months', 'description': 'Change on validated incontinence quality of life questionnaire from baseline to 6, 12 and 24 months'}, {'measure': 'Incidence of urethral stricture and device erosion after ACT implantation', 'timeFrame': '6, 12 and 24 months', 'description': 'Cumulative incidence of ACT related clinically relevant urethral structure and device erosions (the best : 0)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bladder Exstrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.\n\nThe ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Boys and girls \\> 5 years with bladder exstrophy or isolated epispadias;\n* sphincteric incontinence (leak point pressure \\< 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);\n* normal renal function (eGFR \\> 90ml/min);\n* no (or stable) upper urinary tract dilatation in ultrasound.\n\nExclusion Criteria:\n\n* under 5 years or more than 18 years old;\n* renal insufficiency (acute or chronic);\n* evolutive deterioration of the upper urinary tract (hydronephrosis);\n* unmanageable detrusor instability;\n* residual volume greater than 100 ml after voiding;\n* bleeding disorders."}, 'identificationModule': {'nctId': 'NCT04935918', 'acronym': 'ACT', 'briefTitle': 'EVALUATION OF THE SAFETY AND EFFICACY OF ADJUSTABLE CONTINENCE THERAPY BALLOONS IN BLADDER EXSTROPHY AND INCONTINENT EPISPADIAS PATIENTS', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'officialTitle': 'PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS', 'orgStudyIdInfo': {'id': '2019-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Arm 1', 'description': 'Children with bladder exstrophy or isolated epispadias', 'interventionNames': ['Device: ACT']}], 'interventions': [{'name': 'ACT', 'type': 'DEVICE', 'description': 'Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck. The ACT system is a permanent implant designed for the correction of incontinence in patients.', 'armGroupLabels': ['Study Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'PACA', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alice FAURE, MD', 'role': 'CONTACT', 'email': 'alice.faure@ap-hm.fr', 'phone': '04.91.96.81.41'}, {'name': 'Claire MORANDO', 'role': 'CONTACT', 'email': 'claire.morando@ap-hm.fr', 'phone': '04 91 38 21 83'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Alice FAURE, MD', 'role': 'CONTACT', 'email': 'alice.faure@ap-hm.fr', 'phone': '04.91.96.81.41'}, {'name': 'Claire MORANDO', 'role': 'CONTACT', 'email': 'claire.morando@ap-hm.fr', 'phone': '04 91 38 21 83'}], 'overallOfficials': [{'name': 'Emilie GARRIDO-PRADALIE', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}