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OpenTrials
Completed

NCT Number: NCT02138149

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

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neurogenic Detrusor Overactivity Neurogenic Lower Urinary Tract Dysfunction Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: day 0

    only participants with spinal cord injury

  4. International Prostate Symptom Score (I-PSS)

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 14, 2014
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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