Back to resultsIncidence of Urinary Tract Infection After Urodynamic Investigation
Primary Purpose
Neurogenic Bladder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
urodynamic examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Neurogenic Bladder focused on measuring urinary tract infection, urodynamics, spinal cord injury
Eligibility 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
Sites / Locations
- Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal cord injured
Arm Description
Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson)
Outcomes
Primary Outcome Measures
Incidence of urinary tract infection following 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
Name and number of identified bacterial species
Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract
Incidence of urinary tract infection before urodynamic investigation
every patient receives the urine examination before the urodynamic investigation to detect a potentially urinary tract infection
Full Information
NCT ID
NCT01297647
First Posted
February 16, 2011
Last Updated
December 15, 2016
Sponsor
Balgrist University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01297647
Brief Title
Incidence of Urinary Tract Infection After Urodynamic Investigation
Official Title
Incidence of Urinary Tract Infection and Germ Identification After Urodynamic Investigation in Patients With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Balgrist University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder
Keywords
urinary tract infection, urodynamics, spinal cord injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
317 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal cord injured
Arm Type
Experimental
Arm Description
Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson)
Intervention Type
Procedure
Intervention Name(s)
urodynamic examination
Intervention Description
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 Measure Information:
Title
Incidence of urinary tract infection following urodynamic investigation
Description
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
Time Frame
3 days after urodynamic investigation
Secondary Outcome Measure Information:
Title
Name and number of identified bacterial species
Time Frame
30 minutes before examination
Title
Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract
Time Frame
3 days after examination
Title
Incidence of urinary tract infection before urodynamic investigation
Description
every patient receives the urine examination before the urodynamic investigation to detect a potentially urinary tract infection
Time Frame
30 minutes before urodynamic investigation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
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Incidence of Urinary Tract Infection After Urodynamic Investigation
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