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

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

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.

Study Overview

• Status: Completed
• Conditions: Urinary Tract Infection
• Intervention / Treatment: Other: sonographic assessment of residual urine, urine culture

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 .

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Switzerland
  • LU
    • Nottwil, LU, Switzerland, 6207
      • Swiss Paraplegic Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of residual urine	determined by ultrasound	change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Centre Nottwil
• Investigators: Principal Investigator: Jürgen Pannek, Prof., Swiss Paraplegic Center, Nottwil, Switzerland

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: May 1, 2012
• First Submitted That Met QC Criteria: May 15, 2012
• First Posted (Estimate): May 17, 2012

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Urinary Tract Infection; Bacteriuria; Spinal Cord Injuries; Intermittent Catheterization; Prostatitis; Pyuria; Residual Urine
• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Wounds and Injuries; Disease Attributes; Prostatic Diseases; Trauma, Nervous System; Spinal Cord Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Spinal Cord Injuries; Prostatitis
• Other Study ID Numbers: 2011-16