Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2025-12-31 @ 10:28 PM
Study NCT ID:
NCT00770406
Status:
UNKNOWN
Last Update Posted:
2009-08-04
First Post:
2008-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-03', 'studyFirstSubmitDate': '2008-10-09', 'studyFirstSubmitQcDate': '2008-10-09', 'lastUpdatePostDateStruct': {'date': '2009-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incontinence episode frequency', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Urge Urinary Incontinence']}, 'descriptionModule': {'briefSummary': 'A pilot study to examine efficacy and safety of intravesical botulinum toxin type A.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* refractory urge urinary incontinence\n\nExclusion Criteria:\n\n* neurological disease\n* pregnant or lactating\n* bladder neoplasias'}, 'identificationModule': {'nctId': 'NCT00770406', 'briefTitle': 'Intravesical Instillation of Botulinum Toxin Type A to Patients With Urge Urinary Incontinence', 'organization': {'class': 'OTHER', 'fullName': 'Glostrup University Hospital, Copenhagen'}, 'officialTitle': 'Intravesikal Instillation af Botulinum Toxin Type A Til Patienter Med Urge Urininkontinens', 'orgStudyIdInfo': {'id': 'BTXA2008'}}, 'armsInterventionsModule': {'interventions': [{'name': 'botulinum toxin type A', 'type': 'DRUG', 'description': '100 or 200 units intravesically'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2600', 'city': 'Glostrup Municipality', 'state': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Soren Brostrom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Glostrup Hospital', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'centralContacts': [{'name': 'Soren Brostrom, MD, PhD', 'role': 'CONTACT', 'email': 'soren@brostrom.dk', 'phone': '+45-43232243'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Soren Brostrom, MD, PhD', 'oldOrganization': 'Glostrup University Hospital,Copenhagen'}}}}