Spinal Cord Injury Clinical Trial
Official title:
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury
NCT number | NCT01299792 |
Other study ID # | 2009-07 |
Secondary ID | EK900 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 2009 |
Est. completion date | October 2011 |
Verified date | February 2024 |
Source | Swiss Paraplegic Research, Nottwil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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. In 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. Hypothesis: 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.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2011 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - neurogenic bladder dysfunction due to spinal cord injury - ability to understand German language - willingness and capability to undergo urodynamic testing - age > or = 18 years Exclusion Criteria: - acute urinary infection at the time of examination - known bladder tumor or bladder stone - age < 18 years - not capable to understand aim and purpose of the examination |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss paraplecic centre | Nottwil |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Research, Nottwil |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | correlation bladder wall thickness and detrusor compliance | measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume | calculated from maximum bladder filling | |
Secondary | correlation bladder wall thickness and maximum detrusor pressure | correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase | measurement at maximum bladder capacity |
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