Neuro-urological Outcome After Spinal Cord Injury

December 15, 2016 updated by: Thomas Kessler, Balgrist University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8008
        • Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with SCI for at least 5 years
Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Other: Video-urodynamic examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urodynamic evaluation
Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death)
Max. cystometric capacity, compliance, detrusor leak point pressure
5 years after SCI, yearly thereafter (participants are followed until death)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
secondary complications
Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death)
recurrent tract infection, deterioration of the upper urinary tract
5 years after SCI, yearly thereafter (participants are followed until death)
imaging of the upper urinary tract
Time Frame: 5 years after SCI, yearly thereafter (participants are followed until death)
videocystography, ultrasound
5 years after SCI, yearly thereafter (participants are followed until death)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balgrist University Hospital

Investigators

  • Principal Investigator: Jens Wöllner, Dr. med., Balgrist University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

February 16, 2011

First Submitted That Met QC Criteria

February 16, 2011

First Posted (Estimate)

February 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-2010-0207/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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