Neuro-urological Outcome After Spinal Cord Injury

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas M Kessler, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT01297660
First received: February 16, 2011
Last updated: January 7, 2013
Last verified: January 2013

February 16, 2011
January 7, 2013
January 2010
September 2010   (final data collection date for primary outcome measure)
Urodynamic evaluation [ Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death) ] [ Designated as safety issue: No ]
Max. cystometric capacity, compliance, detrusor leak point pressure
Same as current
Complete list of historical versions of study NCT01297660 on ClinicalTrials.gov Archive Site
  • secondary complications [ Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death) ] [ Designated as safety issue: No ]
    recurrent tract infection, detoriation of the upper urinary tract
  • imaging of the upper urinary tract [ Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death) ] [ Designated as safety issue: No ]
    videocystography, ultrasound
Same as current
Not Provided
Not Provided
 
Neuro-urological Outcome After Spinal Cord Injury
Not Provided

Most patients with spinal cord injury suffer from bladder dysfunction which may - especially in the long-term - impair renal function. Improved treatment during the last decades improved life expectancy and quality of life. This study evaluates the bladder function in the long-term after spinal cord injury.

Bladder dysfunction is a common consequence of spinal cord injury and depends on the completeness and the level of the lesion. Patients with suprasacral injury usually suffer from neurogenic detrusor overactivity mostly combined with detrusor sphincter dyssynergia. Without adequate treatment, this adverse combination puts the upper urinary tract at risk due to high intravesical pressure often causing vesico-ureteral reflux. Based on improved therapeutic options in the last decades, life expectancy and quality of life constantly increased in spinal cord injury patients. The investigators aim to evaluate the bladder function in the long-term after spinal cord injury.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

Ages Eligibility: minimum 18 years old Genders Eligibility: female and male

Urinary Bladder Neurogenic Dysfunction
Other: Video-urodynamic examination
Other Name: video-urodynamic examination
patients with SCI for at least 5 years
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Intervention: Other: Video-urodynamic examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Spinal cord injury for at least 5 years
  • Neurogenic lower urinary tract dysfunction
  • Written informed consent

Exclusion Criteria:

  • Lower urinary tract dysfunction due to other causes than spinal cord injury
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01297660
EK 2010-0207/01
No
Thomas M Kessler, Balgrist University Hospital
Balgrist University Hospital
Not Provided
Principal Investigator: Jens Wöllner, Dr. med. Balgrist University Hospital
Balgrist University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP