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Completed

NCT Number: NCT01297673

Reflux in 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

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Key information

Conditions

Vesico-Ureteral Reflux Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Urinary Bladder Diseases Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Zurich, Canton of Zurich, 8008, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

video-urodynamic examination

Procedure

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 outcomes

  1. Incidence and degree of vesico ureter renal reflux

    Time frame: average: yearly scheduled control

    video urodynamic, ultrasound examination

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 17, 2011
Registry last updated
Dec 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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