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

NCT ID: NCT01601041

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-02-28

Brief Summary

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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

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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

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Urinary Tract Infection

Keywords

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Urinary Tract Infection Bacteriuria Pyuria Prostatitis Intermittent Catheterization Spinal Cord Injuries Residual Urine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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urinary tract infection

urinary tract infection in male patients with neurogenic bladder dysfunction due to spinal cord injury managed by intermittent catheterization

sonographic assessment of residual urine, urine culture

Intervention Type OTHER

residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage

control group

less than three urinary tract infections / year

sonographic assessment of residual urine, urine culture

Intervention Type OTHER

residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage

Interventions

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sonographic assessment of residual urine, urine culture

residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage

Intervention Type OTHER

Other Intervention Names

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ultrasound intermittent catheterization

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jürgen Pannek, Prof.

Role: PRINCIPAL_INVESTIGATOR

Swiss Paraplegic Center, Nottwil, Switzerland

Locations

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Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2011-16

Identifier Type: -

Identifier Source: org_study_id