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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01601041
First received: May 1, 2012
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  Purpose

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.

Condition Intervention
Urinary Tract Infection
 Other: sonographic assessment of residual urine, urine culture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • amount of residual urine [ Time Frame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment ] [ Designated as safety issue: No ]
    determined by ultrasound


Secondary Outcome Measures:
  • bacterial prostate infection [ Time Frame: 5-10 minutes before and after prostate massage ] [ Designated as safety issue: No ]
    urinary culture

  • bacteriuria [ Time Frame: 5-10 minutes before and after prostate massage ] [ Designated as safety issue: No ]
    urine dip stick

  • number of leucocytes in urine [ Time Frame: 5-10 minutes before and after prostate massage ] [ Designated as safety issue: No ]
    urine dip stick

  • number of erythrocytes in urine [ Time Frame: 5-10 minutes before and after prostate massage ] [ Designated as safety issue: No ]
    urine dip stick

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    age

  • type of neurogenic bladder dysfunction [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • type of catheter used for intermittent catheterization [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • annual rate of symptomatic urinary tract infections [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    sex

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    time since spinal cord injury

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    level and degree of spinal cord injury (ASIA impairment score)


Enrollment: 60
Study Start Date: December 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
urinary tract infection
urinary tract infection in male patients with neurogenic bladder dysfunction due to spinal cord injury managed by intermittent catheterization
 Other: sonographic assessment of residual urine, urine culture
residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
Other Names:
  • ultrasound
  • intermittent catheterization
control group
less than three urinary tract infections / year
 Other: sonographic assessment of residual urine, urine culture
residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
Other Names:
  • ultrasound
  • intermittent catheterization

Detailed Description:

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 .

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male patients with chronic (> 1 year) spinal cord injury who perform intermittent catheterization due to neurogenic bladder dysfunction

Criteria

Inclusion Criteria:

  • male patients with chronic (> 1 year) spinal cord injury
  • bladder management by intermittent catheterization

Exclusion Criteria:

  • symptomatic urinary tract infection
  • prostate pathology
  • immunodeficiency
  • antibiotic therapy
  • missing informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01601041

Locations
Switzerland
Swiss Paraplegic Centre
Nottwil, LU, Switzerland, 6207
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jürgen Pannek, Prof. Swiss Paraplegic Center, Nottwil, Switzerland
  More Information

No publications provided

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01601041     History of Changes
Other Study ID Numbers: JP-003
Study First Received: May 1, 2012
Last Updated: February 11, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
Urinary Tract Infection
Bacteriuria
Pyuria
Prostatitis
 Intermittent Catheterization
Spinal Cord Injuries
Residual Urine

Additional relevant MeSH terms:
Prostatitis
Spinal Cord Injuries
Urinary Tract Infections
Prostatic Diseases
Genital Diseases, Male
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013