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Is the Nerve Growth Factor (NGF) a Useful Biomarker in Neurogenic Bladder Dysfunction After Spinal Cord Injury?

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ClinicalTrials.gov Identifier: NCT02138149
Recruitment Status : Completed
First Posted : May 14, 2014
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

Study Description
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Brief Summary:

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.


Condition or disease
Spinal Cord Injury Neurogenic Detrusor Overactivity Neurogenic Lower Urinary Tract Dysfunction

Study Design
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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Control
Time Perspective: Prospective
Study Start Date : November 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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Groups and Cohorts
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Group/Cohort
spinal cord injury
individuals with neurogenic lower urinary tract dysfunction
control group
individuals with physiologic bladder function


Outcome Measures
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Primary Outcome Measures :
  1. urinary concentration of nerve growth factor [ Time Frame: day 0 ]

Secondary Outcome Measures :
  1. serum concentration of nerve growth factor [ Time Frame: day 0 ]
  2. demographics [ Time Frame: day 0 ]
  3. urodynamics [ Time Frame: day 0 ]
    only participants with spinal cord injury

  4. International Prostate Symptom Score (I-PSS) [ Time Frame: day 0 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
individuals suffering from neurogenic lower urinary tract dysfunction, namely neurogenic detrusor overactivity
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138149


Locations
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Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
More Information
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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT02138149    
Other Study ID Numbers: 2013-22
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Keywords provided by Swiss Paraplegic Centre Nottwil:
spinal cord injury
neurogenic lower urinary tract dysfunction
nerve growth factor
neurogenic detrusor overactivity
urodynamics
Additional relevant MeSH terms:
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Spinal Cord Injuries
Urinary Bladder, Overactive
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Trauma, Nervous System
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations