Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT01297660
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2011-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuro-urological Outcome After Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-15', 'studyFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2016-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urodynamic evaluation', 'timeFrame': '5 years after SCI, yearly thereafter (participants are followed until death)', 'description': 'Max. cystometric capacity, compliance, detrusor leak point pressure'}], 'secondaryOutcomes': [{'measure': 'secondary complications', 'timeFrame': '5 years after SCI, yearly thereafter (participants are followed until death)', 'description': 'recurrent tract infection, deterioration of the upper urinary tract'}, {'measure': 'imaging of the upper urinary tract', 'timeFrame': '5 years after SCI, yearly thereafter (participants are followed until death)', 'description': 'videocystography, ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neurogenic detrusor overactivity', 'detrusor sphincter dyssynergia', 'compliance', 'video urodynamic', 'spinal cord injury'], 'conditions': ['Urinary Bladder Neurogenic Dysfunction']}, 'descriptionModule': {'briefSummary': 'Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.', 'detailedDescription': 'Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Ages Eligibility: minimum 18 years old Genders Eligibility: female and male', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal cord injury for at least 5 years\n* Neurogenic lower urinary tract dysfunction\n* Written informed consent\n\nExclusion Criteria:\n\n* Lower urinary tract dysfunction due to other causes than spinal cord injury'}, 'identificationModule': {'nctId': 'NCT01297660', 'briefTitle': 'Neuro-urological Outcome After Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Balgrist University Hospital'}, 'orgStudyIdInfo': {'id': 'KEK-2010-0207/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with SCI for at least 5 years', 'description': 'Ages Eligibility: minimum 18 years Genders Eligibility: female and male', 'interventionNames': ['Other: Video-urodynamic examination']}], 'interventions': [{'name': 'Video-urodynamic examination', 'type': 'OTHER', 'armGroupLabels': ['patients with SCI for at least 5 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8008', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Jens Wöllner, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Balgrist University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balgrist University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Thomas Kessler', 'investigatorAffiliation': 'Balgrist University Hospital'}}}}