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Incidence of Urinary Tract Infection After Urodynamic Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01297647
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
Thomas Kessler, Balgrist University Hospital

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

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Procedure: urodynamic examination Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 317 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury
Study Start Date : May 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

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Arm Intervention/treatment
Experimental: Spinal cord injured
Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson)
Procedure: urodynamic examination

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 Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297647


Locations
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Switzerland
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
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Responsible Party: Thomas Kessler, Executive physician, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01297647    
Other Study ID Numbers: EK 2010-0191/0
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: December 16, 2016
Last Verified: December 2016
Keywords provided by Thomas Kessler, Balgrist University Hospital:
urinary tract infection
urodynamics
spinal cord injury
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Urinary Bladder, Neurogenic
Nervous System Diseases
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases