Urinary Sensor for Cystourethrography

Rambam Health Care Campus

Status: Completed

Conditions: Radiation Dose During VCUG

Treatments: Other: placebo; Device: Urinary sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT00547820

OBrook2518CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 month to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children referred for VCUG procedure at out department

Exclusion criteria

• children with pacemakers
• decline to participate

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

with application of urinary sensor

Treatment:

Device: Urinary sensor

B

Placebo Comparator group

Description:

without use of urinary sensor

Treatment:

Other: placebo