Viewing Study NCT00461292

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Ignite Creation Date: 2025-12-24 @ 3:43 PM
Ignite Modification Date: 2025-12-27 @ 7:39 AM
Study NCT ID: NCT00461292
Status: COMPLETED
Last Update Posted: 2015-10-02
First Post: 2007-04-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, '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': 'D019274', 'term': 'Botulinum Toxins, Type A'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated. S(AE)s are displayed for the placebo-controlled treatment Cycle 1.', 'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)', 'otherNumAtRisk': 89, 'otherNumAffected': 70, 'seriousNumAtRisk': 89, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)', 'otherNumAtRisk': 91, 'otherNumAffected': 63, 'seriousNumAtRisk': 91, 'seriousNumAffected': 17}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)', 'otherNumAtRisk': 90, 'otherNumAffected': 52, 'seriousNumAtRisk': 90, 'seriousNumAffected': 23}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Septic shock', 'notes': 'Event not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Endocarditis enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Bursa injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urethral injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Urine cytology abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Joint contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Renal failure acute', 'notes': 'Event not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Renal impairment', 'notes': 'Event not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Respiratory failure', 'notes': 'Event not related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 90, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Number of Weekly Episodes of Urinary Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '31.2', 'spread': '18.14', 'groupId': 'OG000'}, {'value': '32.5', 'spread': '18.44', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '30.67', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-19.4', 'spread': '25.67', 'groupId': 'OG000'}, {'value': '-21.8', 'spread': '18.06', 'groupId': 'OG001'}, {'value': '-13.2', 'spread': '20.02', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. 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MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.', 'unitOfMeasure': 'Milliliters (mL) of urine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, defined as all patients who started the study (randomized)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Detrusor Pressure (MDP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '42.1', 'spread': '33.21', 'groupId': 'OG000'}, {'value': '51.7', 'spread': '40.95', 'groupId': 'OG001'}, {'value': '41.5', 'spread': '31.17', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '-26.9', 'spread': '33.17', 'groupId': 'OG000'}, {'value': '-28.5', 'spread': '47.82', 'groupId': 'OG001'}, {'value': '6.4', 'spread': '41.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.', 'unitOfMeasure': 'Centimeters of water (cm H2O)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, defined as all patients who started the study (randomized)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)'}, {'id': 'OG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '36.32', 'spread': '18.685', 'groupId': 'OG000'}, {'value': '37.46', 'spread': '20.109', 'groupId': 'OG001'}, {'value': '35.72', 'spread': '18.656', 'groupId': 'OG002'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '24.26', 'spread': '28.981', 'groupId': 'OG000'}, {'value': '24.43', 'spread': '25.372', 'groupId': 'OG001'}, {'value': '11.71', 'spread': '20.163', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6', 'description': "Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement.", 'unitOfMeasure': 'Number on a Scale (Score)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat, defined as all patients who started the study (randomized)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)'}, {'id': 'FG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)'}], 'periods': [{'title': 'Treatment Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '92'}, {'groupId': 'FG002', 'numSubjects': '92'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '80'}, {'groupId': 'FG002', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}]}, {'title': 'Treatment Cycle 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '32 from the 300U group + 31 from the Placebo group entered Cycle 2', 'groupId': 'FG000', 'numSubjects': '63'}, {'comment': '42 from the 200U group + 32 from the Placebo group entered Cycle 2', 'groupId': 'FG001', 'numSubjects': '74'}, {'comment': 'Cycle 1 Placebo pts were randomized to receive 300U or 200 U in Cycle 2', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '275', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A (300U)', 'description': 'botulinum toxin Type A (300U)'}, {'id': 'BG001', 'title': 'Botulinum Toxin Type A (200U)', 'description': 'botulinum toxin Type A (200U)'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Normal saline (placebo)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< 40 years', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}, {'title': 'Between 40 and 64 years', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '172', 'groupId': 'BG003'}]}]}, {'title': 'Between 65 and 74 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': '>= 75 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '120', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 275}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2011-03-31', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-17', 'studyFirstSubmitDate': '2007-04-13', 'dispFirstSubmitQcDate': '2011-03-31', 'resultsFirstSubmitDate': '2011-09-09', 'studyFirstSubmitQcDate': '2007-04-13', 'dispFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-09', 'studyFirstPostDateStruct': {'date': '2007-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Number of Weekly Episodes of Urinary Incontinence', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from baseline in the weekly frequency of incontinence episodes at Week 6 after the first treatment. Incontinence is defined as involuntary loss of urine as recorded in a patient bladder diary. A negative number change from baseline indicates a reduction in incontinence episodes (improvement).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Maximum Cystometric Capacity (MCC)', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from baseline in MCC at Week 6. MCC represents the maximum volume of urine the bladder holds. A positive number change from baseline represents an improvement (increase) in maximum volume of urine the bladder holds.'}, {'measure': 'Change From Baseline in Maximum Detrusor Pressure (MDP)', 'timeFrame': 'Baseline, Week 6', 'description': 'Change from baseline in MDP during the first involuntary detrusor contraction at week 6. MDP represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle. The greater the negative number change from baseline, the better the improvement.'}, {'measure': 'Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire', 'timeFrame': 'Baseline, Week 6', 'description': "Change from baseline in I-QOL questionnaire total score at Week 6, as completed by the patient. The I-QOL is a validated, disease-specific quality of life (QOL) questionnaire containing 22 questions designed to measure impact of urinary incontinence on patients' lives. Each question is answered on a 5-point scale (1 = worst QOL, and 5 = best QOL). The scores are totaled over the 22 questions and normalized to a score of 0-100 (0=worst QOL and 100=best QOL). A positive change from baseline represents an improvement."}]}, 'conditionsModule': {'conditions': ['Overactive Bladder']}, 'referencesModule': {'references': [{'pmid': '25288099', 'type': 'DERIVED', 'citation': 'Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.'}, {'pmid': '22965657', 'type': 'DERIVED', 'citation': 'Sussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10.'}, {'pmid': '21798658', 'type': 'DERIVED', 'citation': 'Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis\n* Inadequate response to anticholinergic medication used to treat overactive bladder\n\nExclusion Criteria:\n\n* History or evidence of pelvic or urologic abnormality\n* Previous or current diagnosis of bladder or prostate cancer\n* Urinary tract infection at time of enrollment'}, 'identificationModule': {'nctId': 'NCT00461292', 'briefTitle': 'Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-516'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'botulinum toxin Type A (200U)', 'interventionNames': ['Biological: botulinum toxin Type A (200U)']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'botulinum toxin Type A (300U)', 'interventionNames': ['Biological: botulinum toxin Type A (300U)']}, {'type': 'OTHER', 'label': '3', 'description': 'placebo; botulinum toxin Type A (200U)', 'interventionNames': ['Other: Normal saline (Placebo); botulinum toxin Type A (200U)']}, {'type': 'OTHER', 'label': '4', 'description': 'placebo; botulinum toxin Type A (300U)', 'interventionNames': ['Other: Normal saline (Placebo); botulinum toxin Type A (300U)']}], 'interventions': [{'name': 'botulinum toxin Type A (200U)', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®'], 'description': 'botulinum toxin Type A 200 U injection at Day 1 followed by botulinum toxin Type A 200 U injection \\> Week 12; injections into detrusor', 'armGroupLabels': ['1']}, {'name': 'botulinum toxin Type A (300U)', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®'], 'description': 'botulinum toxin Type A 300 U injection on Day 1 followed by botulinum toxin Type A 300 U injection \\> Week 12; injections into detrusor', 'armGroupLabels': ['2']}, {'name': 'Normal saline (Placebo); botulinum toxin Type A (200U)', 'type': 'OTHER', 'otherNames': ['BOTOX®'], 'description': 'Placebo injection on Day 1 followed by botulinum toxin Type A 200 U injection \\> 12 weeks; injections into detrusor', 'armGroupLabels': ['3']}, {'name': 'Normal saline (Placebo); botulinum toxin Type A (300U)', 'type': 'OTHER', 'otherNames': ['BOTOX®'], 'description': 'Placebo injection on Day 1 followed by botulinum toxin Type A 300 U injection \\> Week 12; injections into detrusor', 'armGroupLabels': ['4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Middlebury', 'state': 'Connecticut', 'country': 'United States', 'geoPoint': {'lat': 41.52787, 'lon': -73.12761}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'Victoria', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 48.4359, 'lon': -123.35155}}, {'city': 'Salouël', 'country': 'France', 'geoPoint': {'lat': 49.86988, 'lon': 2.2434}}, {'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Porto', 'country': 'Portugal', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'city': 'Singapore', 'country': 'Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'city': 'Santa Cruz de Tenerife', 'country': 'Spain', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Hualien City', 'country': 'Taiwan', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'city': 'Scunthorpe', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.57905, 'lon': -0.65437}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}