Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedNovember 22, 2016
November 1, 2016
1.2 years
May 1, 2012
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
amount of residual urine
determined by ultrasound
change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment
Secondary Outcomes (11)
bacterial prostate infection
5-10 minutes before and after prostate massage
bacteriuria
5-10 minutes before and after prostate massage
number of leucocytes in urine
5-10 minutes before and after prostate massage
number of erythrocytes in urine
5-10 minutes before and after prostate massage
patient characteristics
day 0
- +6 more secondary outcomes
Study Arms (2)
urinary tract infection
urinary tract infection in male patients with neurogenic bladder dysfunction due to spinal cord injury managed by intermittent catheterization
control group
less than three urinary tract infections / year
Interventions
residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
Eligibility Criteria
Male patients with chronic (\> 1 year) spinal cord injury who perform intermittent catheterization due to neurogenic bladder dysfunction
You may qualify if:
- male patients with chronic (\> 1 year) spinal cord injury
- bladder management by intermittent catheterization
You may not qualify if:
- symptomatic urinary tract infection
- prostate pathology
- immunodeficiency
- antibiotic therapy
- missing informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jürgen Pannek, Prof.
Swiss Paraplegic Center, Nottwil, Switzerland
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 17, 2012
Study Start
December 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
November 22, 2016
Record last verified: 2016-11