Promedon VICTO+ Instructions D'utilisation page 13

• Dissect around the bulbar urethra, where
the cuff is placed.
• Open the cuff by taking the button out of
the hole and cut the white tube.
• Explant the cuff.
• Make a lower abdominal incision where
the PRB and SRB are placed.
• First, take the SRB off the body and then
repeat the same process for the PRB.
• Make a blunt dissection to facilitate the
pump removal from the scrotum.
• Check that there are no remnants of the
explanted product inside the body.
• Close and dress the perineal and
abdominal incision.
NOTE: If any of these steps complicate the
patient's health during the surgical procedure,
cut the tubes and remove all components
separately.
IMAGING
X-RAY VISIBILITY OF VICTO
The VICTO+ implant does not contain a
radio-opaque solution and therefore, it cannot
be imaged using plain radiography (x-ray).
However, there are two other methods that
can be used to image the device in order to
investigate function.
MAGNETIC RESONANCE
The device can be imaged using magnetic
resonance imaging as described in the paper
by Deng, et al.
NOTE: See Magnetic Resonance (MR)
environment – references.
FLEXIBLE CYSTOMETRY
The function of the cuff can be visualized
using flexible cystometry with the cuff inflated
and deflated.
ULTRASOUND DIAGNOSTICS
The balloons of the VICTO+ implant can be
easily visualized using an ultrasound. With
appropriate settings, the outline, particularly
the highlighted top and bottom of the balloons,
can be seen.
The straight-line distance between these
highlights will give the diameter of the
balloons. When the cuff is normally inflated
between voidings then both the SRB and
PRB should be very nearly the same diameter
and pressure.
From the diameter of the balloon, and using
the following formula, the added volume can
be determined [(4/3π(D/2)³)-9].
By using this ultrasound technique, it is also
possible to determine the normal functioning
of the device during voiding. Pump the
sphincter cuff down with about 2-3 good
squeezes and notice the enlargement of the
PRB. After waiting for about 10-15 minutes,
during which time the cuff will be fully re-
inflated, the balloon should have returned to
approximately the same size.
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Figure 13