Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 11:54 PM
Study NCT ID:
NCT05911594
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2023-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-14', 'studyFirstSubmitDate': '2023-05-14', 'studyFirstSubmitQcDate': '2023-06-17', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overactive bladder symptom score', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months after the intervention', 'description': 'the Overactive bladder symptom score (OABSS) questionnaire will be calculated which consists of four items; namely, daytime frequency (score: 0-2), night-time frequency (score: 0-3), urgency (score: 0-5), and urgency incontinence (score: 0-5). The results scores were summed and a score of\\>8 suggesting an overactive bladder'}], 'secondaryOutcomes': [{'measure': 'Patient Perception of Bladder Condition (PPBC) scale', 'timeFrame': 'Baseline, 3, 6, 9 and 12 months after the intervention', 'description': "The Patient Perception of Bladder Condition (PPBC) scale will be calculated which includes 6-point describing patient's comment of his/her bladder problems and ranging from 1: Not at all, 2: Some very minor, 3: Some minor, 4: some moderate, 5: severe, 6: many severe problems."}, {'measure': "Patients' satisfaction", 'timeFrame': 'Up to the 12-month follow-up period', 'description': "The Patients' satisfaction will be assessed by the Likert scale (self-report scale where 0 = strong dissatisfaction, 1 = dissatisfaction, 2 = neutral, 3 = satisfaction, and 4 = strong satisfaction)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Overactive Bladder'], 'conditions': ['BOTOX', 'Percutaneous Tibial Nerve Stimulation']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the outcome of simultaneous intradetrusor BOTOX (IDB) injection and Percutaneous tibial nerve stimulation (PTNS) for management of children with recurrent wetness since at least 6 months.', 'detailedDescription': 'Overactive bladder is a syndrome characterized by symptoms of urgency, with or without urgency incontinence, usually with increased daytime frequency and nocturia. The Neurogenic or myogenic bladder dysfunction can lead to the symptoms that characterize Overactive bladder. Normal bladder contraction occurs when the muscarinic receptors in the detrusor muscle are stimulated with acetylcholine. Although the pathogenesis of Overactive bladder is not fully explained; sensitization of afferent nerves, deactivation of inhibitory mechanisms, and the emergence of contractions similar to primitive voiding reflexes are shown as pathogenetic mechanisms. Another hypothesis is that the number of intercellular connections among detrusor myocytes increase, and these cells are spontaneously stimulated.\n\nIn addition to the fact that the etiopathogenesis cannot be explained clearly and due to the intense relationship with the autonomic nervous system, undesirable systemic side effects are common in treatments applied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children with non-neurogenic overactive bladder defined after exclusion of neurogenic causes not responding to medical treatment for 6 months, and\n* aged of 7-16 years\n* presenting with recurrent night-time with occasional day-time wetness for overactive bladder.\n\nExclusion Criteria:\n\n* recurrent OAB manifestations within less than 6 months after the previous monotherapy\n* obstructive urinary tract diseases\n* a history of pelvic surgery\n* anatomical abnormalities\n* neurogenic bladder\n* syndromes that affect the bladder functions\n* either current infection that was evidenced by urinalysis and culture or within the last two months\n* systemic diseases inducing liability for wetness'}, 'identificationModule': {'nctId': 'NCT05911594', 'briefTitle': 'IDB Injection Combined With PTNS for Managing Children With OAB Not Responding to Monotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Efficacy and Safety of Intradetrusor BOTOX Injection Combined With Percutaneous Tibial Nerve Stimulation for Managing Children With Overactive Bladder Not Responding to Monotherapy', 'orgStudyIdInfo': {'id': 'Rc 14-2-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solifenacin group', 'description': 'Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment', 'interventionNames': ['Drug: Solifenacin group']}, {'type': 'EXPERIMENTAL', 'label': 'Percutaneous tibial nerve stimulation group', 'description': 'Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy', 'interventionNames': ['Procedure: Percutaneous tibial nerve stimulation group']}, {'type': 'EXPERIMENTAL', 'label': 'Intradetrusor BOTOX group', 'description': 'Patients in this group will receive Intradetrusor BOTOX after the failure of medical therapy', 'interventionNames': ['Drug: Intradetrusor BOTOX group']}, {'type': 'EXPERIMENTAL', 'label': 'Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group', 'description': 'Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after the failure of medical therapy', 'interventionNames': ['Combination Product: Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group']}], 'interventions': [{'name': 'Solifenacin group', 'type': 'DRUG', 'description': 'Patients in this group will receive medical treatment (Solifenacin 5 mg once or twice daily) without any second line of treatment', 'armGroupLabels': ['Solifenacin group']}, {'name': 'Percutaneous tibial nerve stimulation group', 'type': 'PROCEDURE', 'description': 'Patients in this group will receive Percutaneous tibial nerve stimulation after failure of medical therapy', 'armGroupLabels': ['Percutaneous tibial nerve stimulation group']}, {'name': 'Intradetrusor BOTOX group', 'type': 'DRUG', 'description': 'Patients in this group will receive Intradetrusor BOTOX after failure of medical', 'armGroupLabels': ['Intradetrusor BOTOX group']}, {'name': 'Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group', 'type': 'COMBINATION_PRODUCT', 'description': 'Patients in this group will receive Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation after failure of medical', 'armGroupLabels': ['Intradetrusor BOTOX combined with Percutaneous tibial nerve stimulation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Qalyubiyya', 'country': 'Egypt', 'facility': 'Pediatric Urology departments Benha University Hospitals', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'One year after the end of the study', 'ipdSharing': 'YES', 'description': 'The study will be available under a reasonable request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt', 'investigatorFullName': 'Tamer Abd El-Wahab Diab', 'investigatorAffiliation': 'Benha University'}}}}