Spinal Cord Injury Clinical Trial
Official title:
Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Verified date | December 2016 |
Source | Balgrist University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Observational |
The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management
Status | Completed |
Enrollment | 120 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Spinal cord injury - Neurogenic lower urinary tract dysfunction - Written informed consent Exclusion Criteria: - Lower urinary tract dysfunction due to other causes than spinal cord injury |
Observational Model: Case-Only, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Switzerland | Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital | Zürich |
Lead Sponsor | Collaborator |
---|---|
Balgrist University Hospital |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and degree of vesico ureter renal reflux | video urodynamic, ultrasound examination | average: yearly scheduled control | No |
Secondary | pdet (cmH2O) | urodynamic parameter, detrusor pressure | average: yearly scheduled control | No |
Secondary | Medication | name of drugs and applied dosis | average: yearly scheduled examination | No |
Secondary | possible complications | urinary tract infection, pyelonephritis, renal dysfunction | average: yearly scheduled examination | No |
Secondary | maximum cystometric capacity | the volume at which a patient, with normal sensation, fells he/she can no longer delay micturition | average: yearly scheduled control | No |
Secondary | compliance mL/cmH2O | Compliance is the change in volume divided by change in detrusor pressure expressed as mL/cmH2O. | average: yearly scheduled control | No |
Secondary | bladder management | most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients | average: yearly scheduled control | No |
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