Urinary Sensor for Cystourethrography

Not Applicable

Completed

• Conditions: Radiation Dose During VCUG
• Interventions: Device: Urinary sensor; Other: placebo

• Registration Number: NCT00547820
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

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.

Study Timeline

• Study Start: 2007-07
• Status Verified: 2007-10
• Study First Submitted: 2007-10-20
• Study First Submitted QC: 2007-10-22
• Study First Posted: 2007-10-23
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2009-10-27
• Last Update Posted: 2009-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• children referred for VCUG procedure at out department

Exclusion Criteria

• children with pacemakers
• decline to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Urinary sensor	with application of urinary sensor
B	placebo	without use of urinary sensor

Primary Outcome Measures

Name	Time	Method
Radiation dose during VCUG procedure

Trial Locations

Locations (1)

Department of Diagnostic Imaging, Rambam Health Care Campus; 🇮🇱 Haifa, Israel