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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.
 
ClinicalTrials.gov Identifier: NCT01297673
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Kessler, Balgrist University Hospital

Tracking Information
First Submitted Date February 16, 2011
First Posted Date February 17, 2011
Last Update Posted Date December 16, 2016
Study Start Date January 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2011)
Incidence and degree of vesico ureter renal reflux [ Time Frame: average: yearly scheduled control ]
video urodynamic, ultrasound examination
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 15, 2016)
  • pdet (cmH2O) [ Time Frame: average: yearly scheduled control ]
    urodynamic parameter, detrusor pressure
  • Medication [ Time Frame: average: yearly scheduled examination ]
    name of drugs and applied dosis
  • possible complications [ Time Frame: average: yearly scheduled examination ]
    urinary tract infection, pyelonephritis, renal dysfunction
  • 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
  • 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.
  • bladder management [ Time Frame: average: yearly scheduled control ]
    most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients
Original Secondary Outcome Measures
 (submitted: February 16, 2011)
  • pdet (cmH2O) [ Time Frame: average: yearly scheduled control ]
    urodynamic parameter, detrusor pressure
  • Medication [ Time Frame: average: yearly sceduled examination ]
    name of drugs and applied dosis
  • possible complications [ Time Frame: average: yearly sceduled examination ]
    urinary tract infection, pyelonephritis, renal dysfunction
  • 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
  • compliance mL/cmH2O [ Time Frame: average: yearly scheduled control ]
    Compliance is the change in volume diveded by change in detrusor pressure expressed as mL/cmH2O.
  • bladder management [ Time Frame: average: yearly scheduled control ]
    most common: intermittent catheterisation, indwelling catheter, external condom urinal for male patients
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Reflux in Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
Official Title Vesico-ureteral Reflux in a Contemporary Series of Spinal Cord Injury Patients With Neurogenic Lower Urinary Tract Dysfunction
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
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Ages Eligibility: minimum 18 years Genders Eligibility: female and male
Condition
  • Vesico-ureteral Reflux
  • Spinal Cord Injury
Intervention 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
Study Groups/Cohorts Spinal cord injury
Patients with neurogenic lower urinary tract dysfunction due to spinal cord injury with regular urodynamic examination
Intervention: Procedure: video-urodynamic examination
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 16, 2011)
120
Original Actual Enrollment Same as current
Actual Study Completion Date August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01297673
Other Study ID Numbers EK 2010-0207/02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Thomas Kessler, Balgrist University Hospital
Study Sponsor Balgrist University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Balgrist University Hospital
Verification Date December 2016