Clinical trial NCT01601041: Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Tract Infection
Keywords: Urinary Tract Infection
Bacteriuria
Pyuria
Prostatitis
Intermittent Catheterization
Spinal Cord Injuries
Residual Urine
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2012-05-17
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 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 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

Primary outcomes:
measure: amount of residual urine
timeFrame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment
Secondary outcomes:
measure: bacterial prostate infection
timeFrame: 5-10 minutes before and after prostate massage
measure: bacteriuria
timeFrame: 5-10 minutes before and after prostate massage
measure: number of leucocytes in urine
timeFrame: 5-10 minutes before and after prostate massage
measure: number of erythrocytes in urine
timeFrame: 5-10 minutes before and after prostate massage
measure: patient characteristics
timeFrame: day 0
measure: type of neurogenic bladder dysfunction
timeFrame: day 0
measure: type of catheter used for intermittent catheterization
timeFrame: day 0
measure: annual rate of symptomatic urinary tract infections
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
measure: patient characteristics
timeFrame: day 0
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
affiliation: Swiss Paraplegic Center, Nottwil, Switzerland
name: Jürgen Pannek, Prof.
role: PRINCIPAL_INVESTIGATOR
References: