Incidence of Urinary Tract Infection After Urodynamic Investigation

Neurogenic Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297647
• Other study ID #: EK 2010-0191/0
• Status: Completed
• Phase: N/A
• First received: February 16, 2011
• Last updated: December 15, 2016
• Start date: May 2010
• Est. completion date: May 2012

Study information

• Verified date: December 2016
• Source: Balgrist University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Infection
• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Balgrist University Hospital

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 days after urodynamic investigation	No
Secondary	Name and number of identified bacterial species		30 minutes before examination	No
Secondary	Number of hospitalized and number of ambulatory patients with infection of the lower urinary tract		3 days after examination	No
Secondary	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	30 minutes before urodynamic investigation	No