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Incidence of Urinary Tract Infection After Urodynamic Investigation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas M Kessler, Balgrist University Hospital
ClinicalTrials.gov Identifier:
NCT01297647
First received: February 16, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention
Neurogenic Bladder
 Procedure: urodynamic examination

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Balgrist University Hospital:

Primary Outcome Measures:
  • Incidence of urinary tract infection following urodynamic investigation [ Time Frame: 3 days after urodynamic investigation ] [ Designated as safety issue: No ]
    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:
  • Name and number of identified bacterial species [ Time Frame: 30 minutes before examination ] [ Designated as safety issue: No ]
  • Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract [ Time Frame: 3 days after examination ] [ Designated as safety issue: No ]
  • Incidence of urinary tract infection before urodynamic investigation [ Time Frame: 30 minutes before urodynamic investigation ] [ Designated as safety issue: No ]
    every patient receives the urine examination before the urodynamic investigation to detect a potentially urinary tract infection


Enrollment: 317
Study Start Date: May 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297647

Locations
Switzerland
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Zürich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
  More Information

No publications provided

Responsible Party: Thomas M Kessler, Executive physician, Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT01297647     History of Changes
Other Study ID Numbers: EK 2010-0191/0
Study First Received: February 16, 2011
Last Updated: January 7, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Balgrist University Hospital:
urinary tract infection
urodynamics
spinal cord injury

Additional relevant MeSH terms:
Urinary Bladder, Neurogenic
Spinal Cord Injuries
Urinary Tract Infections
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
 Signs and Symptoms
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Infection

ClinicalTrials.gov processed this record on May 19, 2013