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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury Neurogenic Detrusor Overactivity Neurogenic Lower Urinary Tract Dysfunction

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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spinal cord injury

individuals with neurogenic lower urinary tract dysfunction

No interventions assigned to this group

control group

individuals with physiologic bladder function

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* physiologic bladder function

* neurogenic detrusor overactivity
* presentation for urodynamic examination

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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2013-22

Identifier Type: -

Identifier Source: org_study_id