Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-01 @ 5:01 PM
Study NCT ID:
NCT07030803
Status:
RECRUITING
Last Update Posted:
2025-11-18
First Post:
2025-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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': 'C005419', 'term': 'oxybutynin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 124}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-04-29', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of DVISS score between PTNS treatment group and oxybutynin group', 'timeFrame': 'at 3 months', 'description': "DVISS score is : Dysfunctional Voiding and Incontinence Symptoms Score (DVISS) Questionnaire.\n\nThe DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format.\n\nThe DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD."}], 'secondaryOutcomes': [{'measure': 'variation of treatment duration between both groups', 'timeFrame': 'at 6 months'}, {'measure': 'variation of time to treatment efficacy between both groups', 'timeFrame': 'at 6 months'}, {'measure': 'variation of tolerance between both groups', 'timeFrame': 'at 3 months'}, {'measure': 'variation of tolerance between both groups', 'timeFrame': 'at 6 months'}, {'measure': 'variation of compliance between both groups', 'timeFrame': 'at 3 months', 'description': 'variation of compliance between both groups'}, {'measure': 'variation of compliance between both groups', 'timeFrame': 'at 6 months', 'description': 'variation of compliance between both groups'}, {'measure': 'variation of long-term efficacy between both groups', 'timeFrame': 'at 12 months'}, {'measure': 'variation of long-term efficacy between both groups', 'timeFrame': 'at 18 months'}, {'measure': 'variation of long-term efficacy of AOB frequency between both groups', 'timeFrame': 'at 24 months', 'description': "Long term efficacy of OAB frequency is measured with DVISS score. The DVISS is a 13-item instrument that includes 1 QOL question. The first 5 questions are scored using an ordinal scale with the remainder in binary format.\n\nThe DVISS scores are based on the estimated odds ratio (OR) for each question between cases and controls. For example, a score of 1 is given if the item's OR is between 2 and 10, and a score of 5 is given if the OR is greater than 50. The total score can range from 0 to 35 with a cutoff score of 8.5 having 90% sensitivity and specificity at detecting BBD."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive Bladder', 'transcutaneous neurostimulation', 'posterior tibial nerve stimulation'], 'conditions': ['Overactive Bladder (OAB)', 'Transcutaneous Neurostimulation', 'Posterior Tibial Nerve Stimulation']}, 'descriptionModule': {'briefSummary': 'The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment.\n\nBefore inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 6 to 16 years\n* Showing signs of OAB (pollakiuria (\\> 8 micturitions/d and/or urgenturia(\\>x2/week) and/or daytime urine leakage (1/d) and/or nocturia x2/night)\n* No treatment for more than 3 months\n* Urotherapy rules followed for at least 1 month\n* Beneficiary of a social security plan\n* Signature of consent by parents/legal guardian(s) and child's agreement\n\nExclusion Criteria:\n\n* Neurological cause of bladder dysfunction,\n* History of pelvic surgery,\n* Significant post-micturition residual (\\> 10% of micturition),\n* Recurrent urinary tract infections (\\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.\n* Pregnant or breast-feeding adolescents\n* Severe constipation resistant to treatment (Rome IV),\n* Contraindication to oxybutynin\n* Contraindication to the use of TENS (Urostim)"}, 'identificationModule': {'nctId': 'NCT07030803', 'acronym': 'HAV-O-TENS', 'briefTitle': 'Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation', 'orgStudyIdInfo': {'id': 'PI2023_843_0176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'oxybutynin', 'interventionNames': ['Other: Oxybutynin']}, {'type': 'EXPERIMENTAL', 'label': 'TENS', 'interventionNames': ['Device: medical device Urostim']}], 'interventions': [{'name': 'Oxybutynin', 'type': 'OTHER', 'description': 'oxybutynin', 'armGroupLabels': ['oxybutynin']}, {'name': 'medical device Urostim', 'type': 'DEVICE', 'description': 'medical device used to deliver posterior tibial nerve stimulation (PTNS)', 'armGroupLabels': ['TENS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Elodie Haraux, Pr', 'role': 'CONTACT', 'email': 'Haraux.elodie@chu-amiens.fr', 'phone': '33+322836787'}], 'facility': 'CHRU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Elodie Haraux, Pr', 'role': 'CONTACT', 'email': 'Haraux.elodie@chu-amiens.fr', 'phone': '33+322836787'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Rouen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}