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

This study has been withdrawn prior to enrollment.
(Inability to obtain grant funding)
Information provided by:
McMaster University Identifier:
First received: February 17, 2009
Last updated: September 16, 2016
Last verified: September 2016

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 Intervention
Urinary Tract Infection Procedure: Ultrasound prior to bladder catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pediatric Volumetric Bladder Ultrasound Study

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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). ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Dr. Andrew Worster, Hamilton Health Sciences Identifier: NCT00847392     History of Changes
Other Study ID Numbers: PV-BUS
Study First Received: February 17, 2009
Last Updated: September 16, 2016

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

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases processed this record on August 22, 2017