Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-25 @ 3:02 PM
Study NCT ID:
NCT01299792
Status:
COMPLETED
Last Update Posted:
2024-02-13
First Post:
2010-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2010-12-10', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'correlation bladder wall thickness and detrusor compliance', 'timeFrame': 'calculated from maximum bladder filling', 'description': 'measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume'}], 'secondaryOutcomes': [{'measure': 'correlation bladder wall thickness and maximum detrusor pressure', 'timeFrame': 'measurement at maximum bladder capacity', 'description': 'correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal cord injury', 'urodynamics', 'ultrasound', 'neurogenic bladder dysfunction'], 'conditions': ['Spinal Cord Injury']}, 'descriptionModule': {'briefSummary': 'Video-urodynamic investigations are regarded as the current standard diagnostics for neurogenic bladder dysfunction in patients with spinal cord injury. This examination is exact, but time consuming, costly and associated with the risk of urinary tract infection.\n\nIn patients with lower urinary tract symptoms due to benign prostate hyperplasia, sonographic measurement of bladder wall thickness has been demonstrated to be able to replace urodynamic testing for the diagnosis of infravesical obstruction.\n\nHypothesis: measurement of bladder wall thickness in patients with neurogenic bladder dysfunction due to spinal cord injury is closely related to the known risk factors for upper urinary tract deterioration (bladder compliance, detrusor leak point pressure) in this group of patients and can therefore replace urodynamic examination in selected cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'individuals with neurogenic bladder dysfunction due to spinal cord injury', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* neurogenic bladder dysfunction due to spinal cord injury\n* ability to understand German language\n* willingness and capability to undergo urodynamic testing\n* age \\> or = 18 years\n\nExclusion Criteria:\n\n* acute urinary infection at the time of examination\n* known bladder tumor or bladder stone\n* age \\< 18 years\n* not capable to understand aim and purpose of the examination'}, 'identificationModule': {'nctId': 'NCT01299792', 'briefTitle': 'Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction', 'organization': {'class': 'NETWORK', 'fullName': 'Swiss Paraplegic Research, Nottwil'}, 'officialTitle': 'Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury', 'orgStudyIdInfo': {'id': '2009-07'}, 'secondaryIdInfos': [{'id': 'EK900', 'type': 'REGISTRY', 'domain': 'Ethic committee of Lucerne, Switzerland'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'one arm; neurogenic bladder dysfunction', 'description': 'evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury', 'interventionNames': ['Other: sonographic measurement of bladder wall thickness']}], 'interventions': [{'name': 'sonographic measurement of bladder wall thickness', 'type': 'OTHER', 'description': 'measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation', 'armGroupLabels': ['one arm; neurogenic bladder dysfunction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6007', 'city': 'Nottwil', 'country': 'Switzerland', 'facility': 'Swiss paraplecic centre', 'geoPoint': {'lat': 47.13469, 'lon': 8.13774}}], 'overallOfficials': [{'name': 'Juergen Pannek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swiss Paraplegic Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Paraplegic Research, Nottwil', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}