Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

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

Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

The purpose of this study is to investigate the incidence of reflux in patients with spinal cord injury in relation to the lesion level, duration of injury and bladder management

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vesico-ureteral reflux was the main cause for renal failure and reduced life expectancy in patients with neurogenic bladder dysfunction due to spinal cord injury. Neurogenic detrusor overactivity leads to high intravesical pressure and may induce reflux. Decreasing intravesical pressure and increasing bladder capacity is necessary to prevent reflux and secondary renal failure.

Study Type

Observational

Enrollment (Actual)

120

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 Genders Eligibility: female and male

Description

Inclusion Criteria:

  • Spinal cord injury
  • 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
Spinal cord injury
Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination
Procedure: video-urodynamic examination
Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and degree of vesico ureter renal reflux
Time Frame: average: yearly scheduled control
video urodynamic, ultrasound examination
average: yearly scheduled control

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pdet (cmH2O)
Time Frame: average: yearly scheduled control
urodynamic parameter, detrusor pressure
average: yearly scheduled control
Medication
Time Frame: average: yearly scheduled examination
name of drugs and applied dosis
average: yearly scheduled examination
possible complications
Time Frame: average: yearly scheduled examination
urinary tract infection, pyelonephritis, renal dysfunction
average: yearly scheduled examination
maximum cystometric capacity
Time Frame: average: yearly scheduled control
the volume at which a patient, with normal sensation, fells he/she can no longer delay micturition
average: yearly scheduled control
compliance mL/cmH2O
Time Frame: average: yearly scheduled control
Compliance is the change in volume divided by change in detrusor pressure expressed as mL/cmH2O.
average: yearly scheduled control
bladder management
Time Frame: average: yearly scheduled control
most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients
average: yearly scheduled control

Collaborators and Investigators

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

Sponsor

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)

August 1, 2010

Study Completion (Actual)

August 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

  • EK 2010-0207/02

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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