Viewing Study NCT01003457


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Study NCT ID: NCT01003457
Status: COMPLETED
Last Update Posted: 2009-10-28
First Post: 2009-10-27
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity
Sponsor:
Organization:

Raw JSON

{'hasResults': False, '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': 'D019220', 'term': 'High-Energy Shock Waves'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-10-27', 'studyFirstSubmitDate': '2009-10-27', 'studyFirstSubmitQcDate': '2009-10-27', 'lastUpdatePostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Detrusor Overactivity']}, 'referencesModule': {'references': [{'pmid': '20535449', 'type': 'DERIVED', 'citation': 'Serati M, Salvatore S, Cattoni E, Soligo M, Cromi A, Ghezzi F. Ultrasound measurement of bladder wall thickness in different forms of detrusor overactivity. Int Urogynecol J. 2010 Nov;21(11):1405-11. doi: 10.1007/s00192-010-1194-1. Epub 2010 Jun 10.'}]}, 'descriptionModule': {'briefSummary': 'In the last decade, several authors proposed ultrasound measurement of Bladder wall thickness (BWT) for the screening of the voiding dysfunction and of the detrusor overactivity (DO). The aims of the investigator prospective study were:\n\n* to compare the ultrasonographic measurement of BWT in women with DO vs women with other urodynamic diagnosis in a very large population.\n* to verify whether the BWT in women with DO can be different in the clinically or urodinamically different forms of DO.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all women with urinary dysfunction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women referred to our Urogynecology Unit from January 2005 to December 2008 for symptoms of OAB, stress urinary incontinence or mixed incontinence and sottoposte a prove urodinamiche complete were included in this prospective study\n\nExclusion Criteria:\n\n* The investigators excluded women with documented recurrent urinary tract infections\n* Previous antimuscarinic treatment\n* Previous pelvic surgery\n* Neurological disease\n* Vaginal prolapse \\> I stage\n* Symptoms or clinical and/or urodynamic signs of voiding dysfunction\n* Patients included in other ongoing clinical trials during the same study period.'}, 'identificationModule': {'nctId': 'NCT01003457', 'briefTitle': 'Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity', 'organization': {'class': 'OTHER', 'fullName': "Università degli Studi dell'Insubria"}, 'officialTitle': 'Ultrasonographic Bladder Wall Thickness and Different Forms of Detrusor Overactivity', 'orgStudyIdInfo': {'id': 'uninsubria1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'detrusor overactivity', 'interventionNames': ['Other: ultrasonography']}], 'interventions': [{'name': 'ultrasonography', 'type': 'OTHER', 'description': 'transvaginal ultrasonography of bladder wall thickness', 'armGroupLabels': ['detrusor overactivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21100', 'city': 'Varese', 'state': 'varese', 'country': 'Italy', 'facility': 'University of Insubria', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Università degli Studi dell'Insubria", 'class': 'OTHER'}}}}