Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT00345332
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2006-06-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014549', 'term': 'Urinary Incontinence'}], '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'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amy_keller@urmc.rochester.edu', 'phone': '585-273-3232', 'title': 'Division of Urogynecology', 'organization': 'University of Rochester'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Placebo Group', 'description': '6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.', 'otherNumAtRisk': 11, 'otherNumAffected': 3, 'seriousNumAtRisk': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Botox Group', 'description': 'BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.', 'otherNumAtRisk': 20, 'otherNumAffected': 11, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'post void retention volumes > 200cc', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incontinent Episodes Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.'}, {'id': 'OG001', 'title': 'Botox Group', 'description': 'BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.34', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '3.90', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'week 13', 'description': 'The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.', 'unitOfMeasure': 'incontinence episodes per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Incontinence Pads Used Per Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': '6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.'}, {'id': 'OG001', 'title': 'Botox Group', 'description': 'BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.18', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '3.13', 'spread': '0.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'week 13', 'description': 'The number of incontinence pads used per day per day was recorded by each participant in a diary.', 'unitOfMeasure': 'pads per day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': '6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.'}, {'id': 'FG001', 'title': 'Botox Group', 'description': 'Botox (BTX) was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Group', 'description': '6 cc of saline was administered into the detrusor along the bladder base. We injected 0.5 ccs at each injection site.'}, {'id': 'BG001', 'title': 'Botox Group', 'description': 'BTX was administered into the detrusor along the bladder base. BTX was reconstituted in 6 ccs of preservative free saline according to manufacturers instructions. We injected 0.5 ccs at each injection site.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.45', 'spread': '12.85', 'groupId': 'BG000'}, {'value': '65.15', 'spread': '10.83', 'groupId': 'BG001'}, {'value': '65.97', 'spread': '11.55', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-07', 'studyFirstSubmitDate': '2006-06-27', 'resultsFirstSubmitDate': '2016-04-04', 'studyFirstSubmitQcDate': '2006-06-27', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-07', 'studyFirstPostDateStruct': {'date': '2006-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incontinent Episodes Per Day', 'timeFrame': 'week 13', 'description': 'The number of incontinence episodes per day was recorded by each participant in a diary. All incontinence episodes were counted when calculating episodes per day at each time point.'}], 'secondaryOutcomes': [{'measure': 'Number of Incontinence Pads Used Per Day', 'timeFrame': 'week 13', 'description': 'The number of incontinence pads used per day per day was recorded by each participant in a diary.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Urinary Incontinence']}, 'referencesModule': {'references': [{'pmid': '15538257', 'type': 'RESULT', 'citation': 'Flynn MK, Webster GD, Amundsen CL. The effect of botulinum-A toxin on patients with severe urge urinary incontinence. J Urol. 2004 Dec;172(6 Pt 1):2316-20. doi: 10.1097/01.ju.0000143889.00681.3f.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.', 'detailedDescription': 'A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects 21-90 years of age\n* subjects has urinary incontinence on 3 day bladder diary\n* subject has severe incontinence\n* urine dipstick or urine culture negative for urinary tract infection\n* cystometrogram without stress urinary leakage\n* must have failed at least one anti-cholinergic medication\n* negative urine pregnancy test on day of administration of study medication\n\nExclusion Criteria:\n\n* history of carcinoma of the bladder\n* presence of foreign body in the bladder, cystitis or other correctable etiology for Urge Urinary Incontinance\n* gross fecal incontinence\n* known allergy to sulfa or ciprofloxacin or to lidocaine\n* any medical condition that may put the subject at increased risk with exposure to Botox\n* females who are pregnant, breast-feeding, or planning a pregnancy during the study or who are of child-bearing potential\n* known allergy to any of the components in the study medication\n* prior documented resistance to Botox\n* evidence of recent alcohol or drug abuse\n* concurrent participation in another investigational drug or device study within 30 days'}, 'identificationModule': {'nctId': 'NCT00345332', 'briefTitle': 'A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial of Botox for Severe Refractory Urge Urinary Incontinence', 'orgStudyIdInfo': {'id': '12299'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Botox', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'Botox', 'type': 'DRUG', 'description': 'Injected', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Injected', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California at Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Michael K Flynn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}