Clinical Trial: Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Role of Residual Urine and Asymptomatic Prostatitis in the Development of Lower Urinary Tract Infections in Spinal Cord Injury Patients - a Prospective Study

Brief Summary:

The purpose of this prospective study is to investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization.

The following hypotheses will be tested:

  1. The amount of residual urine after intermittent catheterization is significantly greater in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.
  2. The incidence of asymptomatic bacterial prostate infections is significantly higher in SCI patients suffering from frequent (>2 /year) urinary tract infections compared to those without.

Detailed Summary: To investigate the association between the amount of residual urine and asymptomatic bacterial prostate infection with the occurrence of recurrent (>2 /year) symptomatic urinary tract infections in patients suffering from chronic (> 1 year) spinal cord injury (SCI) and neurogenic lower urinary tract dysfunction performing intermittent catheterization, patients perform self-catheterization twice (before and after urodynamic testing. After each catheterization, residual urine is assessed by ultrasound. Prior to urodynamic testing, prostate massage is performed, bacterial cultures of the fluid and the urine are initiated and the results of these cultures will be analysed .
Sponsor: Swiss Paraplegic Centre Nottwil

Current Primary Outcome: amount of residual urine [ Time Frame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment ]

determined by ultrasound


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • bacterial prostate infection [ Time Frame: 5-10 minutes before and after prostate massage ]
    urinary culture
  • bacteriuria [ Time Frame: 5-10 minutes before and after prostate massage ]
    urine dip stick
  • number of leucocytes in urine [ Time Frame: 5-10 minutes before and after prostate massage ]
    urine dip stick
  • number of erythrocytes in urine [ Time Frame: 5-10 minutes before and after prostate massage ]
    urine dip stick
  • patient characteristics [ Time Frame: day 0 ]
    age
  • type of neurogenic bladder dysfunction [ Time Frame: day 0 ]
  • type of catheter used for intermittent catheterization [ Time Frame: day 0 ]
  • annual rate of symptomatic urinary tract infections [ Time Frame: day 0 ]
  • patient characteristics [ Time Frame: day 0 ]
    sex
  • patient characteristics [ Time Frame: day 0 ]
    time since spinal cord injury
  • patient characteristics [ Time Frame: day 0 ]
    level and degree of spinal cord injury (ASIA impairment score)


Original Secondary Outcome: Same as current

Information By: Swiss Paraplegic Centre Nottwil

Dates:
Date Received: May 1, 2012
Date Started: December 2011
Date Completion:
Last Updated: November 21, 2016
Last Verified: November 2016