Urinary Tract InfectionNCT01601041
Role of Residual Urine and Asymptomatic Prostatitis in the Development of Urinary Tract Infections in Spinal Cord Injury
An observational study of Urinary Tract Infection, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- sonographic assessment of residual urine, urine culture
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients with chronic (> 1 year) spinal cord injury who perform intermittent catheterization due to neurogenic bladder dysfunction
Who may be able to join
- male patients with chronic (> 1 year) spinal cord injury
- bladder management by intermittent catheterization
Who cannot join
- symptomatic urinary tract infection
- prostate pathology
- immunodeficiency
- antibiotic therapy
- missing informed consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
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
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:
- 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.
- 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.
Read the 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 .
- Conditions
- Urinary Tract Infection
- Being tested
- sonographic assessment of residual urine, urine culture
- Keywords
- Urinary Tract Infection, Bacteriuria, Pyuria, Prostatitis, Intermittent Catheterization, Spinal Cord Injuries, Residual Urine
- Medical subject headings
- Urinary Tract Infections, Bacteriuria, Pyuria, Prostatitis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonographic assessment of residual urine, urine cultureOther
Also called ultrasound, intermittent catheterization
residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
| Study group | Role | What they receive |
|---|---|---|
| urinary tract infection | urinary tract infection in male patients with neurogenic bladder dysfunction due to spinal cord injury managed by intermittent catheterization Receives: Other: sonographic assessment of residual urine, urine culture | |
| control group | less than three urinary tract infections / year Receives: Other: sonographic assessment of residual urine, urine culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of residual urine
determined by ultrasound
Measured: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment
Secondary outcomes (11)
bacterial prostate infection
urinary culture
Measured: 5-10 minutes before and after prostate massage
bacteriuria
urine dip stick
Measured: 5-10 minutes before and after prostate massage
number of leucocytes in urine
urine dip stick
Measured: 5-10 minutes before and after prostate massage
number of erythrocytes in urine
urine dip stick
Measured: 5-10 minutes before and after prostate massage
patient characteristics
age
Measured: day 0
type of neurogenic bladder dysfunction
Measured: day 0
type of catheter used for intermittent catheterization
Measured: day 0
annual rate of symptomatic urinary tract infections
Measured: day 0
patient characteristics
sex
Measured: day 0
patient characteristics
time since spinal cord injury
Measured: day 0
patient characteristics
level and degree of spinal cord injury (ASIA impairment score)
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startDec 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, Prof., Principal investigator, Swiss Paraplegic Center, Nottwil, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601041
- Sponsor's protocol ID
- 2011-16
- Status last verified
- Nov 2016
- First submitted
- 1 May 2012
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01601041
- Acronym / sponsor ID
- 2011-16
- Conditions
- Urinary Tract Infection
- Keywords
- Urinary Tract Infection, Bacteriuria, Pyuria, Prostatitis, Intermittent Catheterization, Spinal Cord Injuries, Residual Urine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Dec 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| urinary tract infection | – | Other: sonographic assessment of residual urine, urine cultureurinary tract infection in male patients with neurogenic bladder dysfunction due to spinal cord injury managed by intermittent catheterization |
| control group | – | Other: sonographic assessment of residual urine, urine cultureless than three urinary tract infections / year |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients with chronic (> 1 year) spinal cord injury who perform intermittent catheterization due to neurogenic bladder dysfunction
Key inclusion criteria (2 listed)
- male patients with chronic (> 1 year) spinal cord injury
- bladder management by intermittent catheterization
Key exclusion criteria (5 listed)
- symptomatic urinary tract infection
- prostate pathology
- immunodeficiency
- antibiotic therapy
- missing informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonographic assessment of residual urine, urine cultureAlso: ultrasound, intermittent catheterizationresidual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage | Other | control group, urinary tract infection |
Primary outcome
amount of residual urine
Time frame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment
determined by ultrasound
11 secondary outcomes
bacterial prostate infection
Time frame: 5-10 minutes before and after prostate massage
bacteriuria
Time frame: 5-10 minutes before and after prostate massage
number of leucocytes in urine
Time frame: 5-10 minutes before and after prostate massage
number of erythrocytes in urine
Time frame: 5-10 minutes before and after prostate massage
patient characteristics
Time frame: day 0
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
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Pannek, Prof. principal investigator
Swiss Paraplegic Center, Nottwil, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
amount of residual urine (time frame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2016; AzTrials last refreshed its copy on 7 Nov 2026.