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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas M Kessler, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT01297673
First received: February 16, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Vesico-ureteral Reflux
Spinal Cord Injury
 Procedure: video-urodynamic examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Balgrist University Hospital:

Primary Outcome Measures:
  • Incidence and degree of vesico ureter renal reflux [ Time Frame: average: yearly scheduled control ] [ Designated as safety issue: No ]
    video urodynamic, ultrasound examination


Secondary Outcome Measures:
  • pdet (cmH2O) [ Time Frame: average: yearly scheduled control ] [ Designated as safety issue: No ]
    urodynamic parameter, detrusor pressure

  • Medication [ Time Frame: average: yearly sceduled examination ] [ Designated as safety issue: No ]
    name of drugs and applied dosis

  • possible complications [ Time Frame: average: yearly sceduled examination ] [ Designated as safety issue: No ]
    urinary tract infection, pyelonephritis, renal dysfunction

  • maximum cystometric capacity [ Time Frame: average: yearly scheduled control ] [ Designated as safety issue: No ]
    the volume at which a patient, with normal sensation, fells he/she can no longer delay micturition

  • compliance mL/cmH2O [ Time Frame: average: yearly scheduled control ] [ Designated as safety issue: No ]
    Compliance is the change in volume diveded by change in detrusor pressure expressed as mL/cmH2O.

  • bladder management [ Time Frame: average: yearly scheduled control ] [ Designated as safety issue: No ]
    most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients


Enrollment: 120
Study Start Date: January 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 incicence degree and localization of vesico ureteral reflux based on the result of video urodynamics

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.

  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 Genders Eligibility: female and male

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297673

Locations
Switzerland
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
  More Information

No publications provided

Responsible Party: Thomas M Kessler, PD Dr. med., Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01297673     History of Changes
Other Study ID Numbers: EK 2010-0207/02
Study First Received: February 16, 2011
Last Updated: January 7, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Balgrist University Hospital:
vesico-ureteral reflux
neurogenic bladder dysfunction
spinal cord injury

Additional relevant MeSH terms:
Gastroesophageal Reflux
Spinal Cord Injuries
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013