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Urinary Sensor for Cystourethrography

This study has been completed.
Information provided by:
Rambam Health Care Campus Identifier:
First received: October 20, 2007
Last updated: October 27, 2009
Last verified: October 2007
Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

Condition Intervention
Radiation Dose During VCUG Other: placebo Device: Urinary sensor

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Urinary Sensor for Cystourethrography

Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Radiation dose during VCUG procedure

Estimated Enrollment: 20
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
with application of urinary sensor
Device: Urinary sensor
Placebo Comparator: B
without use of urinary sensor
Other: placebo

Detailed Description:
It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.

Ages Eligible for Study:   1 Month to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children referred for VCUG procedure at out department

Exclusion Criteria:

  • children with pacemakers
  • decline to participate
  Contacts and Locations
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Please refer to this study by its identifier: NCT00547820

Department of Diagnostic Imaging, Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Principal Investigator: Olga R Brook, MD Department of Diagnostic Imaging, Rambam Health Care Campus
  More Information Identifier: NCT00547820     History of Changes
Other Study ID Numbers: OBrook2518CTIL
Study First Received: October 20, 2007
Last Updated: October 27, 2009

Keywords provided by Rambam Health Care Campus:
radiation dose
pediatric patients processed this record on September 21, 2017