Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT06408051
Status:
COMPLETED
Last Update Posted:
2024-12-27
First Post:
2024-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 200 IU OnabotulinumtoxinA in Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-21', 'studyFirstSubmitDate': '2024-05-06', 'studyFirstSubmitQcDate': '2024-05-06', 'lastUpdatePostDateStruct': {'date': '2024-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequencies of urination, nocturia, incontinence episodes', 'timeFrame': '1 years', 'description': 'below 8,above 8'}, {'measure': 'urgency,', 'timeFrame': '1 years', 'description': 'present or absent'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment']}, 'descriptionModule': {'briefSummary': 'This study aimed to assess the efficacy and safety of onabotulinumtoxinA (botulinum toxin type A) in patients with idiopathic overactive bladder (OAB) and urinary incontinence who had previously failed to respond to anticholinergic treatment. Additionally, we examined the impact of significant reductions in bladder wall thickness on therapeutic outcomes.', 'detailedDescription': "The efficacy of OnabotulinumtoxinA was investigated in patients who attended urology outpatient clinics between January 2016 and June 2022 for overactive bladder unresponsive to anticholinergic therapy. Baseline symptoms and quality of life data were compared to those at month 6 after the treatment. The voiding diary (for 3 days) of each patient was reviewed to assess and record patients' symptoms. Baseline ultrasound (US)-measured post-void residual urine (PVR) and bladder wall thickness (BWT) values were recorded. Patients with a history of neurological disorders, anticholinergic-naive patients, patients diagnosed with bladder cancer, and those with bladder outlet obstruction were excluded from the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'In patients with overactive bladder and urinary incontinence who had previously failed to respond to anticholinergic treatments', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overactive bladder urge incontinence\n\nExclusion Criteria:\n\n* neurological and/or neurosurgical disorders, anticholinergic-naive patients, bladder cancer, bladder stone, interstitial cystitis, prostate cancer chronic prostatitis bladder outlet obstruction'}, 'identificationModule': {'nctId': 'NCT06408051', 'briefTitle': 'Efficacy of 200 IU OnabotulinumtoxinA in Idiopathic Overactive Bladder Resistant to Anticholinergic Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Hisar Intercontinental Hospital'}, 'officialTitle': 'Efficacy of 200 IU OnabotulinumtoxinA (Botulinum Toxin Type A) in Patients With Idiopathic', 'orgStudyIdInfo': {'id': '10.11.203/23-54'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'singel', 'interventionNames': ['Procedure: Injection of onabotulinumtoxinA into the bladder wall']}], 'interventions': [{'name': 'Injection of onabotulinumtoxinA into the bladder wall', 'type': 'PROCEDURE', 'description': 'BTX was injected into the detrusor muscles at 20 sites', 'armGroupLabels': ['singel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34768', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Basri Cakiroglu', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34768', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Hisar Intercontinental Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hisar Intercontinental Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Basri Cakiroglu', 'investigatorAffiliation': 'Hisar Intercontinental Hospital'}}}}