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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
History of Changes
  Purpose

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.


Condition Intervention
Urinary Bladder Neurogenic Dysfunction
 Other: Video-urodynamic examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Balgrist University Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 55
Study Start Date: January 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with SCI for at least 5 years
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
 Other: Video-urodynamic examination
Other Name: video-urodynamic examination

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297660

Locations
Switzerland
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Investigators
Principal Investigator: Jens Wöllner, Dr. med. Balgrist University Hospital
  More Information

No publications provided

Responsible Party: Thomas M Kessler, PD Dr. med., Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01297660     History of Changes
Other Study ID Numbers: EK 2010-0207/01
Study First Received: February 16, 2011
Last Updated: January 7, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Balgrist University Hospital:
neurogenic detrusor overactivity
detrusor sphincter dyssynergia
compliance
video urodynamic
spinal cord injury

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Spinal Cord Injuries
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013