- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138149
Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?
Spinal cord injury (SCI) almost always affects bladder function as well. As a result of this bladder dysfunction, individuals with SCI have to undergo regular invasive examination of their bladder function (urodynamic examination).
The nerve growth factor (NGF) is released from smooth muscle cells of the bladder, and there are reports, that the concentration of NGF is elevated in the urine of patients with bladder dysfunction. The NGF concentration can also be measured in the blood. The concentration of NGF in the blood and urine of SCI individuals has not yet been investigated. These concentrations may correlate with the severity of bladder dysfunction, and may thus be used to replace or at least reduce the number of the more invasive urodynamic examinations.
The hypothesis that urine and blood NGF concentrations in individuals with SCI are higher compared to individuals with healthy bladder function will be tested.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
LU
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Nottwil, LU, Switzerland, 6207
- Swiss Paraplegic Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Control Group
Inclusion Criteria:
- physiologic bladder function
Exclusion Criteria:
- no signed consent form
- age <18 / >80 years
- urinary tract infection
- bladder surgery
- radiation therapy of the pelvic area
- pregnancy
- bleeding disorder
Study Group
Inclusion Criteria:
- neurogenic detrusor overactivity
- presentation for urodynamic examination
Exclusion Criteria:
- no signed consent form
- age <18 / >80 years
- urinary tract infection
- bladder augmentation
- bladder evacuation by permanent catheterization
- radiation therapy of the pelvic area
- pregnancy
- bleeding disorder
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
spinal cord injury
individuals with neurogenic lower urinary tract dysfunction
|
control group
individuals with physiologic bladder function
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
urinary concentration of nerve growth factor
Time Frame: day 0
|
day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum concentration of nerve growth factor
Time Frame: day 0
|
day 0
|
|
demographics
Time Frame: day 0
|
day 0
|
|
urodynamics
Time Frame: day 0
|
only participants with spinal cord injury
|
day 0
|
International Prostate Symptom Score (I-PSS)
Time Frame: day 0
|
day 0
|
Collaborators and Investigators
Sponsor
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 (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-22 (Other Identifier: AP HM)
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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