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

NCT02138149 | Completed

• 1 other identifier: 2013-22
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• urinary concentration of nerve growth factor

  day 0

Secondary Outcomes (4)

• serum concentration of nerve growth factor

  day 0

• demographics

  day 0

• urodynamics

  day 0

• International Prostate Symptom Score (I-PSS)

  day 0

Study Arms (2)

spinal cord injury

individuals with neurogenic lower urinary tract dysfunction

control group

individuals with physiologic bladder function

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• physiologic bladder function

You may not qualify if:

• no signed consent form
• age \<18 / \>80 years
• urinary tract infection
• bladder surgery
• radiation therapy of the pelvic area
• pregnancy
• bleeding disorder
• Study Group
• neurogenic detrusor overactivity
• presentation for urodynamic examination
• no signed consent form
• age \<18 / \>80 years
• urinary tract infection
• bladder augmentation
• bladder evacuation by permanent catheterization

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Hereditary Sensory and Autonomic Neuropathies

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 14, 2014
• Study Start: November 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

CH (1)