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

Completed

• Conditions: Spinal Cord Injury; Neurogenic Lower Urinary Tract Dysfunction; Neurogenic Detrusor Overactivity

• Registration Number: NCT02138149
• Lead Sponsor: Swiss Paraplegic Research, Nottwil

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-12
• Study First Posted: 2014-05-14
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urinary concentration of nerve growth factor	day 0

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Swiss Paraplegic Centre; 🇨🇭 Nottwil, LU, Switzerland