- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01299792
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction
Sonographic Measurement of Bladder Wall Thickness in Patients With Neurogenic Bladder Dysfunction Due to Spinal Cord Injury
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Nottwil, Switzerland, 6007
- Swiss paraplecic centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
one arm; neurogenic bladder dysfunction
evaluation of the clinical utility of bladder wall thickness as a diagnostic tool in patients with spinal cord injury
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measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation bladder wall thickness and detrusor compliance
Time Frame: calculated from maximum bladder filling
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measurement of detrusor compliance at maximum bladder volume; measurement of bladder wall thickness at maximum bladder volume
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calculated from maximum bladder filling
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
correlation bladder wall thickness and maximum detrusor pressure
Time Frame: measurement at maximum bladder capacity
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correlation between bladder wall thickness and maximum detrusor pressure during the urodynamic storage phase
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measurement at maximum bladder capacity
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Collaborators and Investigators
Investigators
- Principal Investigator: Juergen Pannek, MD, Swiss Paraplegic Centre
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- Urologic Diseases
- Urinary Bladder Diseases
- Neurologic Manifestations
- Wounds and Injuries
- Trauma, Nervous System
- Spinal Cord Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
Other Study ID Numbers
- 2009-07
- EK900 (Registry Identifier: Ethic committee of Lucerne, Switzerland)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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