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NCT Number: NCT01601041

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

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.

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Key information

Conditions

Urinary Tract Infection Bacteriuria Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Infections Male Urogenital Diseases Nervous System Diseases Prostatic Diseases Prostatitis Pyuria Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Tract Infections Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sonographic assessment of residual urine, urine culture

Other

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

Other names: ultrasound, intermittent catheterization

Primary outcomes

  1. amount of residual urine

    Time frame: change from self-catheterization 10 minutes before and 10 minutes after urodynamic assessment

    determined by ultrasound

Secondary outcomes

  1. bacterial prostate infection

    Time frame: 5-10 minutes before and after prostate massage

    urinary culture

  2. bacteriuria

    Time frame: 5-10 minutes before and after prostate massage

    urine dip stick

  3. number of leucocytes in urine

    Time frame: 5-10 minutes before and after prostate massage

    urine dip stick

  4. number of erythrocytes in urine

    Time frame: 5-10 minutes before and after prostate massage

    urine dip stick

  5. patient characteristics

    Time frame: day 0

    age

  6. type of neurogenic bladder dysfunction

    Time frame: day 0

  7. type of catheter used for intermittent catheterization

    Time frame: day 0

  8. annual rate of symptomatic urinary tract infections

    Time frame: day 0

  9. patient characteristics

    Time frame: day 0

    sex

  10. patient characteristics

    Time frame: day 0

    time since spinal cord injury

  11. patient characteristics

    Time frame: day 0

    level and degree of spinal cord injury (ASIA impairment score)

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 17, 2012
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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