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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02138149

Enrollment

Registered

2014-05-14

Start date

2013-11-30

Completion date

2015-11-30

Last updated

2015-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
urinary concentration of nerve growth factor	day 0

Secondary

Measure	Time frame	Description
serum concentration of nerve growth factor	day 0	—
demographics	day 0	—
urodynamics	day 0	only participants with spinal cord injury
International Prostate Symptom Score (I-PSS)	day 0	—

Countries

Switzerland

Outcome results