Neuro-urological Outcome After Spinal Cord Injury
| Tracking Information | |||||
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| First Received Date ICMJE | February 16, 2011 | ||||
| Last Updated Date | January 7, 2013 | ||||
| Start Date ICMJE | January 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Urodynamic evaluation [ Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death) ] [ Designated as safety issue: No ] Max. cystometric capacity, compliance, detrusor leak point pressure |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01297660 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Neuro-urological Outcome After Spinal Cord Injury | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Ages Eligibility: minimum 18 years old Genders Eligibility: female and male |
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| Condition ICMJE | Urinary Bladder Neurogenic Dysfunction | ||||
| Intervention ICMJE | Other: Video-urodynamic examination
Other Name: video-urodynamic examination |
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| Study Group/Cohort (s) | patients with SCI for at least 5 years
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Intervention: Other: Video-urodynamic examination |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 55 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01297660 | ||||
| Other Study ID Numbers ICMJE | EK 2010-0207/01 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Thomas M Kessler, Balgrist University Hospital | ||||
| Study Sponsor ICMJE | Balgrist University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Balgrist University Hospital | ||||
| Verification Date | January 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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