Incidence of Urinary Tract Infection After Urodynamic Investigation

NCT01297647 | Completed

• 1 other identifier: EK 2010-0191/0
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder

Keywords

urinary tract infection; urodynamics; spinal cord injury

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Name and number of identified bacterial species

  30 minutes before examination

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

  3 days after examination

• Incidence of urinary tract infection before urodynamic investigation

  30 minutes before urodynamic investigation

Study Arms (1)

Spinal cord injured

EXPERIMENTAL

Patients with neurogenic lower urinary tract infection (Spinal Cord Injury,MS,M. Parkinson)

Procedure: urodynamic examination

Interventions

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.

Spinal cord injured

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy and breastfeeding
• Current antibiotic therapy

Sponsors & Collaborators

• Balgrist University Hospital: lead

Study Sites (1)

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

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Urinary Tract Infections; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive physician

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 17, 2011
• Study Start: May 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: December 16, 2016

Record last verified: 2016-12

Locations

CH (1)