Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-04-16 @ 7:50 AM
Study NCT ID:
NCT02161159
Status:
COMPLETED
Last Update Posted:
2016-04-18
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder
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': 515}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-14', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-06-09', 'lastUpdatePostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients Who have Greatly Improved or Improved on the 4-Point Treatment Benefit Scale (TBS)', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in Number of Urinary Incontinence Episodes', 'timeFrame': 'Baseline, Week 12'}], 'secondaryOutcomes': [{'measure': 'Time to Re-Injection of BOTOX®', 'timeFrame': '12 Months'}, {'measure': 'Number of Nocturia Episodes', 'timeFrame': '12 Months'}, {'measure': 'Usage of Incontinence Support Products', 'timeFrame': '12 Months'}, {'measure': 'Percentage of Patients Who Have at Least a 50% Reduction in Urinary Incontinence and Urinary Urgency Incontinence', 'timeFrame': 'Baseline, 12 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urinary Incontinence', 'Urinary Bladder, Overactive']}, 'referencesModule': {'references': [{'pmid': '37260130', 'type': 'DERIVED', 'citation': 'Farrelly E, Hamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Yu J, Patel A, Nelson M. One treatment with onabotulinumtoxinA relieves symptoms of overactive bladder in patients refractory to one or more oral medications. Neurourol Urodyn. 2023 Aug;42(6):1203-1213. doi: 10.1002/nau.25221. Epub 2023 Jun 1.'}, {'pmid': '33955921', 'type': 'DERIVED', 'citation': 'Poster. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S89-S189. doi: 10.1097/SPV.0000000000000936. No abstract available.'}, {'pmid': '33955918', 'type': 'DERIVED', 'citation': 'Short orals. Female Pelvic Med Reconstr Surg. 2020 Oct 1;26(10S Suppl 1):S21-S77. doi: 10.1097/SPV.0000000000000934. No abstract available.'}, {'pmid': '32719964', 'type': 'DERIVED', 'citation': 'Hamid R, Lorenzo-Gomez MF, Schulte-Baukloh H, Boroujerdi A, Patel A, Farrelly E. OnabotulinumtoxinA is a well tolerated and effective treatment for refractory overactive bladder in real-world practice. Int Urogynecol J. 2021 Jan;32(1):65-74. doi: 10.1007/s00192-020-04423-0. Epub 2020 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate real world pattern of use of BOTOX® in actual clinical practice in patients with idiopathic overactive bladder (iOAB) with urinary incontinence whose symptoms have not been adequately managed by oral anticholinergic therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients With Urinary Incontinence Due to iOAB', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No prior treatment with botulinum toxin Type A for treatment of iOAB\n\nExclusion Criteria:\n\n* Treatment with any botulinum toxin Type A within 18 months'}, 'identificationModule': {'nctId': 'NCT02161159', 'acronym': 'GRACE', 'briefTitle': 'An Observational Study of BOTOX® for the Management of Urinary Incontinence in Patients With Idiopathic Overactive Bladder', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF/AGN/NS/OAB/002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients With Urinary Incontinence Due to iOAB', 'description': 'Patients with urinary incontinence due to iOAB treated with BOTOX® in accordance with physician standard practice.', 'interventionNames': ['Biological: botulinum toxin Type A']}], 'interventions': [{'name': 'botulinum toxin Type A', 'type': 'BIOLOGICAL', 'otherNames': ['BOTOX®', 'onabotulinumtoxinA'], 'description': 'botulinum toxin Type A administered in accordance with physician standard practice.', 'armGroupLabels': ['Patients With Urinary Incontinence Due to iOAB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97980', 'city': 'Bad Mergentheim', 'country': 'Germany', 'facility': 'David Brix', 'geoPoint': {'lat': 49.4925, 'lon': 9.77361}}, {'zip': '10551', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Urologie Turmschtraße', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12099', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Uwe-Carsten', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12247', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Albrecht Kastein', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14197', 'city': 'Berlin', 'country': 'Germany', 'facility': 'ATURO', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '31303', 'city': 'Burgdorf, Hanover', 'country': 'Germany', 'facility': 'MVZ Burgdorf', 'geoPoint': {'lat': 52.44628, 'lon': 10.0064}}, {'zip': '01099', 'city': 'Dresden', 'country': 'Germany', 'facility': 'Ev.-Luth. Diakonissenanstalt Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '79312', 'city': 'Emmendingen', 'country': 'Germany', 'facility': 'Stefan Carl', 'geoPoint': {'lat': 48.12096, 'lon': 7.85359}}, {'zip': '60439', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Zentrum für Urologie FFM', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Georg-August-Universität Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '06120', 'city': 'Halle', 'country': 'Germany', 'facility': 'Universitätsklinikum Halle (Saale)', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Urologikum Hamburg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '22359', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Urologische Praxis Volksdorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '44649', 'city': 'Herne', 'country': 'Germany', 'facility': 'Claudia Olszak-Warnat', 'geoPoint': {'lat': 51.5388, 'lon': 7.22572}}, {'zip': '67655', 'city': 'Kaiserslautern', 'country': 'Germany', 'facility': 'Westpfalz-Klinikum Kaiserslautern', 'geoPoint': {'lat': 49.443, 'lon': 7.77161}}, {'zip': '24103', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Urologie Zentrum Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '68623', 'city': 'Lampertheim', 'country': 'Germany', 'facility': 'Joachim Weiß', 'geoPoint': {'lat': 49.59786, 'lon': 8.4725}}, {'zip': '84028', 'city': 'Landshut', 'country': 'Germany', 'facility': 'Uro- Vital-Zentrum, GP Hellmeier, Krause et al', 'geoPoint': {'lat': 48.52961, 'lon': 12.16179}}, {'zip': '04109', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Tom Kempe', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '04416', 'city': 'Markkleeberg', 'country': 'Germany', 'facility': 'Institut Dr. Schulze', 'geoPoint': {'lat': 51.2755, 'lon': 12.36906}}, {'zip': '45468', 'city': 'Mülheim', 'country': 'Germany', 'facility': 'Elke Stagge', 'geoPoint': {'lat': 51.43218, 'lon': 6.87967}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitätsklinikum Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '90409', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Urologen am Stadtpark', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': '49076', 'city': 'Osnabrück', 'country': 'Germany', 'facility': 'Urologicum Osnabrück', 'geoPoint': {'lat': 52.27264, 'lon': 8.0498}}, {'zip': '72764', 'city': 'Reutlingen', 'country': 'Germany', 'facility': 'Simone Maier', 'geoPoint': {'lat': 48.49144, 'lon': 9.20427}}, {'zip': '06198', 'city': 'Salzatal OT Schiepzig', 'country': 'Germany', 'facility': 'Andres Melchior'}, {'zip': '06526', 'city': 'Sangerhausen', 'country': 'Germany', 'facility': 'Andreas Reinhard Wicht', 'geoPoint': {'lat': 51.47221, 'lon': 11.29533}}, {'zip': '78224', 'city': 'Singen', 'country': 'Germany', 'facility': 'Franz Hirschle', 'geoPoint': {'lat': 47.75935, 'lon': 8.8403}}, {'zip': '70174', 'city': 'Stuttgart', 'country': 'Germany', 'facility': 'Wolfgang Theurer', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '78532', 'city': 'Tuttlingen', 'country': 'Germany', 'facility': 'Benjamin Fischer', 'geoPoint': {'lat': 47.98464, 'lon': 8.8177}}, {'zip': '78532', 'city': 'Tuttlingen', 'country': 'Germany', 'facility': 'Dietmar Jung', 'geoPoint': {'lat': 47.98464, 'lon': 8.8177}}, {'zip': '78052', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Kontinenzzentrum Südwest', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'zip': '09006', 'city': 'Burgos', 'country': 'Spain', 'facility': 'Hospital Universitario Burgos', 'geoPoint': {'lat': 42.34106, 'lon': -3.70184}}, {'zip': '33394', 'city': 'Gijón', 'country': 'Spain', 'facility': 'Hospital de Cabueñes', 'geoPoint': {'lat': 43.53573, 'lon': -5.66152}}, {'zip': '29010', 'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'zip': '32005', 'city': 'Ourense', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}, {'zip': '33011', 'city': 'Oviedo', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marqués de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41014', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital de Valme', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '30185', 'city': 'Halmstad', 'country': 'Sweden', 'facility': 'Urologimottagningen, Hallands Sjukhus Halmstad', 'geoPoint': {'lat': 56.67446, 'lon': 12.85676}}, {'zip': '11883', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Urologiska kliniken, Södersjukhuset AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '17177', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '18288', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Kvinnokliniken, Danderyds Sjukhus AB', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '59381', 'city': 'Västervik/Kalmar', 'country': 'Sweden', 'facility': 'Kirurgkliniken, Västervik Sjukhus'}, {'zip': 'B15 2TH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Queen Elizabeth Hospital, Queen Elizabeth Medical Centre, Edgbaston', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'G51 4TF', 'city': 'Glasgow, Lanarkshire', 'country': 'United Kingdom', 'facility': 'Southern General Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'LS9 7TF', 'city': 'Leeds, West Yorkshire', 'country': 'United Kingdom', 'facility': "Leeds Teaching Hospitals NHS Trust, St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'NW1 2BU', 'city': 'London', 'country': 'United Kingdom', 'facility': 'University College London Hospitals NHS foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': "Imperial College Healthcare NHS Trust, The Bays, St Mary's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'L35 5DR', 'city': 'Prescot, Merseyside', 'country': 'United Kingdom', 'facility': 'St Helens & Knowsley Teaching Hospitals NHS Trust, Whiston Hospital', 'geoPoint': {'lat': 53.42948, 'lon': -2.80031}}, {'zip': 'SP2 8BJ', 'city': 'Salisbury, Wiltshire', 'country': 'United Kingdom', 'facility': 'Salisbury NHS Foundation Trust, Salisbury District Hospital', 'geoPoint': {'lat': 51.06931, 'lon': -1.79569}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}