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CompletedNCT02138149Updated Nov 17, 2015

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

An observational study in Spinal Cord Injury, Neurogenic Detrusor Overactivity and Neurogenic Lower Urinary Tract Dysfunction, sponsored by Swiss Paraplegic Research, Nottwil. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-17.

Sponsored by Swiss Paraplegic Research, Nottwil · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
47
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Spinal Cord Injury
  • Neurogenic Detrusor Overactivity
  • Neurogenic Lower Urinary Tract Dysfunction

Keywords

  • spinal cord injury
  • neurogenic lower urinary tract dysfunction
  • nerve growth factor
  • neurogenic detrusor overactivity
  • urodynamics
03

In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 47 is below the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Swiss Paraplegic Research, Nottwil is the lead sponsor of 69 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility 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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
47 participants (actual)
Patient registry
No

Groups and cohorts

  • spinal cord injury

    individuals with neurogenic lower urinary tract dysfunction

  • control group

    individuals with physiologic bladder function

06

What researchers measure

Primary outcomes

  1. urinary concentration of nerve growth factor

    Time frame: day 0

Secondary outcomes

  1. serum concentration of nerve growth factor

    Time frame: day 0

  2. demographics

    Time frame: day 0

  3. urodynamics

    only participants with spinal cord injury

    Time frame: day 0

  4. International Prostate Symptom Score (I-PSS)

    Time frame: day 0

07

Study locations

1 site
  • Swiss Paraplegic Centre
    Nottwil, LU 6207, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02138149
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
May 14, 2014
Start date
Nov 2013
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Nov 17, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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