Study to Determine Pediatric Bladder Volume Prior to Catheterization (PV-BUS)

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. Identifier: NCT00847392
Recruitment Status : Withdrawn (Inability to obtain grant funding)
First Posted : February 19, 2009
Last Update Posted : September 19, 2016
Information provided by:
McMaster University

Brief Summary:

This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection.

Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Procedure: Ultrasound prior to bladder catheterization Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric Volumetric Bladder Ultrasound Study
Study Start Date : March 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ultrasound
Bladder ultrasound prior to catheterization
Procedure: Ultrasound prior to bladder catheterization
Bedside ultrasound to estimated volume of urine in bladder
No Intervention: Standard catheterization
No ultrasound prior to bladder catheterization

Primary Outcome Measures :
  1. The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization. [ Time Frame: First feasible attempt at catheterization during ED visit (minutes-hours). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children 0-36 months of age
  • Require urethral catheterization for urine analysis

Exclusion Criteria:

  • Recently voided and unlikely to provide sufficient urine when catheterized
  • Documented or suspected genitourinary abnormalities precluding urethral catheterization
  • Indwelling catheter or urostomy
  • Critical illness
  • No available legal guardian or legal guardian does not understand English well enough to provide informed consent
  • Technical failure of the utlrasound equipment

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 identifier (NCT number): NCT00847392

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L5G4T8
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Principal Investigator: Andrew Worster, MD, MSc Hamilton Health Sciences Corporation

Responsible Party: Dr. Andrew Worster, Hamilton Health Sciences Identifier: NCT00847392     History of Changes
Other Study ID Numbers: PV-BUS
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016

Keywords provided by McMaster University:
Urethral catheterization
Emergency Department
Urinary tract infection

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases