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

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02138149
• Other study ID #: 2013-22
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: November 16, 2015
• Start date: November 2013
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Centre	Nottwil	LU

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary concentration of nerve growth factor		day 0	No
Secondary	serum concentration of nerve growth factor		day 0	No
Secondary	demographics		day 0	No
Secondary	urodynamics	only participants with spinal cord injury	day 0	No
Secondary	International Prostate Symptom Score (I-PSS)		day 0	No