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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297673
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : December 16, 2016
Information provided by (Responsible Party):
Thomas Kessler, Balgrist University Hospital

Brief Summary:
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 or disease Intervention/treatment
Vesico-ureteral Reflux Spinal Cord Injury Procedure: video-urodynamic examination

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.

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Study Type : Observational
Actual Enrollment : 120 participants
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
Study Start Date : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Incidence and degree of vesico ureter renal reflux [ Time Frame: average: yearly scheduled control ]
    video urodynamic, ultrasound examination

Secondary Outcome Measures :
  1. pdet (cmH2O) [ Time Frame: average: yearly scheduled control ]
    urodynamic parameter, detrusor pressure

  2. Medication [ Time Frame: average: yearly scheduled examination ]
    name of drugs and applied dosis

  3. possible complications [ Time Frame: average: yearly scheduled examination ]
    urinary tract infection, pyelonephritis, renal dysfunction

  4. 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

  5. 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.

  6. bladder management [ Time Frame: average: yearly scheduled control ]
    most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ages Eligibility: minimum 18 years Genders Eligibility: female and male

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297673

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Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
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Responsible Party: Thomas Kessler, PD Dr. med., Balgrist University Hospital Identifier: NCT01297673    
Other Study ID Numbers: EK 2010-0207/02
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by Thomas Kessler, Balgrist University Hospital:
vesico-ureteral reflux
neurogenic bladder dysfunction
spinal cord injury
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Spinal Cord Injuries
Vesico-Ureteral Reflux
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases