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Completed

NCT Number: NCT01297647

Incidence of Urinary Tract Infection After Urodynamic Investigation

The purpose of this study is to evaluate the incidence of urinary tract infection after urodynamic investigation and to identify the involved germs.

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Key information

Conditions

Neurogenic Bladder Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Tract Infections Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

About this study

Patients with neurogenic bladder dysfunction after spinal cord injury need lifelong urologic control examinations with CMG (urodynamic examination). The manipulation may cause urinary tract infections which have to be treated. Patients often noticed an infection after a CMG examination. Aim of this study is the determination of the infection rate and germs. Also should be noticed the pre-interventional infections and differences between the causing germs. Simultaneously the investigators test the reliability of the quicktest for urinary infection. Additionally the investigators will examine the Quality of Life in patients with neurogenic bladder dysfunction.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with neurogenic lower urinary tract dysfunction with scheduled urodynamic investigation
  • No antibiotic treatment
  • Written informed consent

Exclusion criteria

  • Pregnancy and breastfeeding
  • Current antibiotic therapy

Treatment and study plan

urodynamic examination

Procedure

Standard urodynamic investigation according to the ICS standard, Good urodynamic practice.Following insertion of 8 F transurethral catheter, retrograde filling of the bladder (20 mL/min) with body warm saline.

Current recording of pabd. , pves and pdet., subsequently pressure flow study. Additionally imaging with fluoroscopy to detect possible vesico ureteral renal reflux.

Primary outcomes

  1. Incidence of urinary tract infection following urodynamic investigation

    Time frame: 3 days after urodynamic investigation

    every patient receives the urine examination before the urodynamic investigation and hospitalized patients additionally 3 days later and ambulatory patients in case of urinary tract infection

Secondary outcomes

  1. Name and number of identified bacterial species

    Time frame: 30 minutes before examination

  2. Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract

    Time frame: 3 days after examination

  3. Incidence of urinary tract infection before urodynamic investigation

    Time frame: 30 minutes before urodynamic investigation

    every patient receives the urine examination before the urodynamic investigation to detect a potentially urinary tract infection

Sponsors and collaborators

Lead sponsor

Balgrist University Hospital

Other

Registry information

Official study title

Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 17, 2011
Registry last updated
Dec 16, 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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