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

November 16, 2015 updated by: Swiss Paraplegic Centre Nottwil

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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • LU
      • Nottwil, LU, Switzerland, 6207
        • Swiss Paraplegic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

individuals suffering from neurogenic lower urinary tract dysfunction, namely neurogenic detrusor overactivity

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 12, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 14, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

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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