Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 1:11 PM
Study NCT ID:
NCT02590250
Status:
COMPLETED
Last Update Posted:
2018-03-26
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'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'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-23', 'studyFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from the baseline value of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF)', 'timeFrame': 'at up to 4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Overactive Bladder']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://AllerganClinicalTrials.com', 'label': 'More Information'}]}, 'descriptionModule': {'briefSummary': 'This is a Post-Marketing Surveillance study in India to evaluate safety and efficacy of BOTOX® (Botulinum Toxin Type A) in the treatment of patients with urinary incontinence due to neurogenic detrusor overactivity or overactive bladder.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with urinary incontinence (due to NDO, eg, as a result of SCI or MS, or due to OAB) who have an inadequate response to or are intolerant of an anticholinergic medication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02590250', 'briefTitle': 'A Safety and Efficacy Study of BOTOX® (Botulinum Toxin Type A) in Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in India', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'officialTitle': 'Evaluation of the Safety and Effectiveness of BOTOX® (Botulinum Toxin Type A) in the Treatment of Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder: A Phase IV Non-interventional Post-marketing Surveillance Study in India', 'orgStudyIdInfo': {'id': '191622-140'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BOTOX®', 'description': 'Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.', 'interventionNames': ['Biological: botulinum toxin Type A']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®', 'onabotulinumtoxinA'], 'description': 'Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.', 'armGroupLabels': ['BOTOX®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560070', 'city': 'Padmanabha Nagar', 'state': 'Banglore', 'country': 'India', 'facility': 'NU Hospitals', 'geoPoint': {'lat': 13.05722, 'lon': 80.21556}}, {'zip': '380007', 'city': 'Ahmedabad', 'state': 'Gujarat', 'country': 'India', 'facility': 'Bodyline Hospitals', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'zip': '560076', 'city': 'Bengaluru', 'state': 'Karnataka', 'country': 'India', 'facility': 'Fortis Hospitals', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '400053', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '411004', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': "AMAI Charitable Trust's ACE Hospital and Research Centre", 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '411040', 'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Inamdar Multispeciality Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'zip': '110001', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Dr. Ram Manohar Lohia Hospital', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Indian Spinal Injuries Centre', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110025', 'city': 'Okhla Road', 'state': 'New Delhi', 'country': 'India', 'facility': 'Fortis Escorts Heart Institute'}, {'zip': '141008', 'city': 'Ludhiana', 'state': 'Punjab', 'country': 'India', 'facility': 'Christian Medical College & Hospital', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}, {'zip': '632004', 'city': 'Vellore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Christian Medical College and Hospital', 'geoPoint': {'lat': 12.9184, 'lon': 79.13255}}, {'zip': '500004', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Global Hospital', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'overallOfficials': [{'name': 'Ahunna Ukah', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}