Ignite Creation Date:
2025-12-24 @ 3:46 PM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01107392
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2010-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Netherlands', 'Taiwan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': {'eventGroups': [{'id': 'EG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.', 'otherNumAtRisk': 158, 'otherNumAffected': 42, 'seriousNumAtRisk': 158, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.', 'otherNumAtRisk': 157, 'otherNumAffected': 44, 'seriousNumAtRisk': 157, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Prostatic specific antigen increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 18}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Haematospermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 16}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'seriousEvents': [{'term': 'Retinal detachment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Carotid artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}, {'term': 'Leukoplakia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 158, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 157, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.8', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '4.56', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '6.61', 'groupId': 'OG000'}, {'value': '-5.6', 'spread': '5.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total International Prostate Symptom Score (IPSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '21.8', 'spread': '4.90', 'groupId': 'OG000'}, {'value': '21.5', 'spread': '4.56', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 6 (n=156,156)', 'categories': [{'measurements': [{'value': '-5.4', 'spread': '5.84', 'groupId': 'OG000'}, {'value': '-5.3', 'spread': '5.27', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24 (n=152,154)', 'categories': [{'measurements': [{'value': '-6.3', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '-6.0', 'spread': '5.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 6, Week 24', 'description': 'IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Peak Urine Flow Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.52', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '2.86', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 6 (n=138,136)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '3.40', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 12 (n=143,147)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '5.24', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '4.38', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Week 24 (n=140,149)', 'categories': [{'measurements': [{'value': '2.5', 'spread': '4.97', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 6, 12 and 24', 'description': 'Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.', 'unitOfMeasure': 'mL/sec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population included all randomized and treated participants with at least one post-baseline IPSS measurement with data available for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Duration of Effect', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'OG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '18.6', 'upperLimit': '20.9'}, {'value': '20.6', 'comment': 'Not estimable.', 'groupId': 'OG001', 'lowerLimit': '20.1', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 Weeks', 'description': 'Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was \\< 4-points.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-treat population included all randomized and treated patients with at least one post-baseline IPSS measurement. Only patients with at least a 4-point reduction from Baseline in total IPSS were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'FG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '158'}, {'groupId': 'FG001', 'numSubjects': '157'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '153'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Administrative decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Botulinum Toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.'}, {'id': 'BG001', 'title': 'Placebo (Normal Saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '≤ 65 Years', 'measurements': [{'value': '89', 'spread': '8.19', 'groupId': 'BG000'}, {'value': '79', 'spread': '8.12', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}]}, {'title': '> 65 Years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '315', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2013-03-14', 'completionDateStruct': {'date': '2012-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-29', 'studyFirstSubmitDate': '2010-04-16', 'dispFirstSubmitQcDate': '2013-03-14', 'resultsFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2010-04-19', 'dispFirstPostDateStruct': {'date': '2013-03-20', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-24', 'studyFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Total International Prostate Symptom Score (IPSS)', 'timeFrame': 'Baseline, Week 6, Week 24', 'description': 'IPSS is a disease-specific outcome measure based on the American Urological Association Symptom Index. The questionnaire consisted of seven items. The patient evaluated their urinary symptoms (incomplete emptying, frequency, hesitancy, urgency, weak stream, straining, and nocturia) during the previous 4 weeks. The total symptom score ranged from 0 (no symptoms) to 35 (most severe symptoms). A negative change from Baseline indicated improvement.'}, {'measure': 'Change From Baseline in Peak Urine Flow Rate', 'timeFrame': 'Baseline, Weeks 6, 12 and 24', 'description': 'Urinary flow was determined by uroflowmetry measured in milliliters/second (mL/sec). An increase from Baseline indicated improvement.'}, {'measure': 'Duration of Effect', 'timeFrame': '24 Weeks', 'description': 'Duration of effect was calculated from the time of the first follow-up visit with a ≥ 4-point reduction from Baseline in IPSS to the next visit when the IPSS change from Baseline was \\< 4-points.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Benign Prostatic Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '24508634', 'type': 'BACKGROUND', 'citation': 'McVary KT, Roehrborn CG, Chartier-Kastler E, Efros M, Bugarin D, Chen R, Patel A, Haag-Molkenteller C. A multicenter, randomized, double-blind, placebo controlled study of onabotulinumtoxinA 200 U to treat lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2014 Jul;192(1):150-6. doi: 10.1016/j.juro.2014.02.004. Epub 2014 Feb 7.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of intraprostatic administration of botulinum toxin Type A (BOTOX®) compared with placebo to treat urinary tract symptoms due to benign prostatic hyperplasia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical enlargement of the prostate gland\n* Body weight ≥ 50 kg or 110 lbs\n\nExclusion Criteria:\n\n* History of chronic prostatitis\n* History of two or more urinary tract infections in the past year or one in the last 6 months\n* History of bladder stones\n* History of previous prostate surgery\n* History of bladder cancer or prostate cancer\n* Any previous or current usage of botulinum toxin therapy of any serotype for any urological condition\n* Botulinum toxin therapy of any serotype for any non-urological condition or usage (e.g., cosmetic) during the previous 12 weeks prior to study entry'}, 'identificationModule': {'nctId': 'NCT01107392', 'briefTitle': 'Safety and Efficacy of Botulinum Toxin Type A to Treat Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '191622-100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'botulinum toxin Type A', 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.', 'interventionNames': ['Drug: botulinum toxin Type A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (Normal saline)', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'DRUG', 'otherNames': ['BOTOX®', 'onabotulinumtoxinA'], 'description': 'botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.', 'armGroupLabels': ['botulinum toxin Type A']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.', 'armGroupLabels': ['Placebo (Normal saline)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Munich', 'country': 'Germany', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'city': 'Manila', 'country': 'Philippines', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Poznan', 'country': 'Poland', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Seoul', 'country': 'South Korea', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}