Prostate-Cryoblation-Consent-Information

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procedure is different for every patient
PROSTATE CRYOBLATION CONSENT
depending on the size of the prostate and the
INFORMATION
amount of cryotherapy needed. The general
WEBSITE SAMPLE PATIENT COPY
range is 2 hours.
What is Cryoblation or Cryotherapy?
A special catheter is placed into the urethra
(tube through which you urinate) and into the
This is a procedure where your doctor will
bladder. The catheter will circulate warm
place small freezing needles into your prostate
water to help protect the urethra and bladder
to kill prostate cancer cells. It does not require
from the freezing effects of the needles. An
cutting of the skin because the needles are
ultrasound probe is placed in your rectum just
placed through small holes in the perineum
like the one placed during your original
(the area behind the scrotum and in front of the
prostate biopsy. Using ultrasound guidance, the
anal region). The needles are then guided into
cryotherapy needles are placed through the
the prostate, freezing gas is injected through the
needles into the prostate and the needles are
then removed.
skin into very specific areas of the prostate.
These needles are hollow to allow a special
freezing gas into the specific areas of the
This procedure is generally used to cure
prostate. As the prostate freezes, an “ice-ball”
prostate cancer. Your doctor has recommended
this procedure most likely because the cancer is
located only in the prostate and has not traveled
elsewhere in the body. This procedure may also
be recommended when we know there is a high
likelihood the cancer has already begun to
spread beyond the prostate. Although not
curative, it is used to achieve “local control” of
the tumor.
Salvage procedure is a commonly used term
when talking about cryotherapy when other
treatments (brachytherapy or external beam
radiation) have failed and we see a continued
develops that can be seen on the ultrasound
increase in your PSA blood test. Cryotherapy is
image. Your doctor will continue the freezing
used to kill the remaining cancer cells that did
not die following the radiation.
until he or she is satisfied that the targeted
You will be placed on your back with your legs
freezing. The doctor wants to get close to the
areas in the prostate have received enough
elevated in stirrups. The duration of the
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outer margins of the prostate without extending

the “ice-ball” and damaging the rectum, the
Rectal blood for a day or two, especially
if you have hemorrhoids.
bladder, the urethra or the nerves. After all the

areas are treated, the catheter in the urethra is
Mild to moderate pain. We will give
you something for pain.
removed and replaced with a simple one that

Infection of the urinary tract or
will remain for several days up to 2 weeks.
urosepsis. We will provide you with
Your urine will come out of this catheter.
antibiotics but you may still get an
infection. It may be a simple bladder
Will there be discomfort?
infection which will get better with a
This procedure will require anesthesia. Discuss
few days of antibiotics; the symptoms
this with your doctor before the procedure. An
are burning when you urinate,
IV catheter will be placed in your hand or arm
frequency and strong urge to urinate.
and sedation medications will be injected into
The infection may get into the blood
the IV catheter. You will get a “sleepy-like”
system. This is urosepsis and you will
feeling and feel very relaxed and go to sleep.
feel very ill. Symptoms include fever,
You will not remember or feel the procedure.
shaking chills, weakness or dizziness,
nausea and vomiting. You may also
Anesthesia has some side effects. Most are
have symptoms of a urinary tract
usually temporary; some may be longer-term
infection with this. With urosepsis, you
problems and will depend on your own risks:

Being overweight or obese

You are a smoker

Have asthma, diabetes, heart disease,
may require a short hospitalization for
IV antibiotics, fluids and observation.
Urosepsis is most common in diabetics,
patients on long-term steroids or those
kidney disease, high blood pressure or
with immune system problems. If you
other medical conditions.
have any urosepsis symptoms after your
discharge from the hospital, contact us
What are the risks of cryoblation?
immediately or go to the nearest
There are risks and complications with this
emergency room.
procedure. They include, but are not limited to

the following:

that could be temporary or long-term.

Constant urge to urinate. This usually
Impotence (erectile dysfunction) due to
the “ice-ball” going outside the prostate
disappears within a few days after the
and damaging the nerves that control
procedure. We will give you medication
erections. This could be impaired
to help with this urgency.

Incontinence (involuntary loss of urine)
function or complete impotence. The
Blood tinged urine lasting a few days.
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damage to the nerves may not become
your ankle and foot. If you have these
immediately noticed. The long-term
symptoms, go directly to the emergency
prognosis will depend on your erectile
room and also call our office.
function before the procedure, the total


freezing time and how your tissue
pulmonary embolus (PE). The blood
reacted to the freezing.
clot in your leg can move into the lung.
Damage to the surrounding organs
The symptoms of a PE are shortness of
such as to the bladder and/or rectum.
breath and possibly chest pain. We will
Most of the time there is no long-term
ask other doctors to be involved with
effect but symptoms that are
the management of blood clots.
bothersome can last such as urinary


Urethra damage or damage to the neck
frequency, urinary and/or bowel
of the bladder. Urethra damage is
urgency, incontinence, burning when
called a stricture or contracture which
you urinate, diarrhea, rectal bleeding
is caused by scar tissue that obstructs
and discomfort.
the flow of urine. You may need to
Urinary retention which is the inability
have a procedure to open the scar. This
to empty your bladder. If the prostate
may come back. If the tissue lining of
becomes swollen from the treatment, it
the urethra breaks down (necrosis) as a
will obstruct the flow of urine. We may
result of the freezing, the obstruction is
need to replace the catheter for a few
extreme and can result in total
days or until further treatment. This
incontinence.
problem generally goes away with time.

Blood clot in your lung called a

Fistula (abnormal passage) between the
You may need a procedure to open the
prostate and rectum can occur,
channel particularly if you had this
although rare and more often in a
problem prior to the procedure. Rarely,
salvage procedure. Less common, the
urinary retention can occur months
fistula may form with the bladder and
after the procedure from a stricture
prostate involved causing total
(narrowing) or urethral necrosis (tissue
incontinence of urine and stool.
breakdown).
Treatment is difficult and often requires
Blood clot in your leg called a deep vein
1 or more reconstructive surgeries
thrombosis (DVT). This usually
involving the colon and/or urinary
presents 2-3 days (or longer) after the
tract.
procedure. The symptoms are pain,

Chronic (long lasting) pain in the area
swelling and tenderness to touch in
that had the procedure. This is rare.
your lower leg (calf), and swelling in
The cause is not always known and
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
usually resolves with time. You may be
any of your medications change after this
referred to a pain specialist if necessary.
meeting, notify us immediately.
Death. The incidence of death during
What happens after the procedure?
or shortly after this procedure is
extremely rare and occurs in less than
After the procedure is finished, you will begin
1% of patients. It may occur as a result
to wake up in the recovery room and will
of a heart attack or a lung event.
remain there until discharged to home.
Sometimes, a patient may be kept overnight for
What do I do to prepare for the procedure?
observation. You will have a catheter and a
You may be asked to have an updated general
small bag attached to your leg when you are
physical exam and be “medically cleared” for
discharged. You will get instructions on how to
the procedure. This will depend on your
care for the catheter and bag. The bag can be
medical condition. The day before your
easily concealed under clothing. Your
procedure, eat a light lunch and light, early
discharge instructions will include instructions
dinner (5-6 p.m.). DO NOT EAT AT LEAST 8
for a follow-up visit to our office. You will be
HOURS PRIOR TO YOUR PROCEDURE or
given an anti-biotic, pain medication and a
anesthesia cannot be used and the procedure
stool softener. You may also receive pills to
will be cancelled. 2 hours before bedtime, you
relax your bladder and anti-inflammatory pills.
will give yourself an enema. You may need to
We will discuss other medications and your
repeat the enema 1 hour before bedtime if you
regular medications with your before you leave.
did not get good results from the first enema.
You will feel tired for a day or so and plan on
You may also be asked to do a 3rd enema when
being out of work for 1 week. Some patients go
you wake on the morning of your procedure.
back to work before then. You may have some
Do not eat or drink anything after midnight
swelling and bruising in the area of needle
prior to your procedure. You may brush your
insertion. Apply ice compresses on and off to
teeth, but do not swallow the water. Discuss
the area for the first 12-24 hours.
your medications with us prior to the
procedure and with the anesthesiologist prior
How do I know if the procedure is
to the procedure. Tell us of any allergies. If you
successful?
take any blood thinners, aspirin or inflammatory
There is no guarantee the cancer will be gone.
medicines, tell us. Refer to the attached list and
You will have urinary symptoms for a few
tell us if you have taken any of these
weeks to several months after the procedure.
medications within the past 10 days. We will
These will slowly go away. The situation is
discuss your medications during your pre-
different in each patient. We will not be able to
procedure meeting and give you instructions. If
determine the success of the treatment or know
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the full degree of side-effects for quite some
medications. Talk to us about these options so
time.
we can determine which option works for you.
We will re-check your PSA several months after
the procedure. It could take up to 2 years
We provide this education material for you and
before your PSA reaches its lowest value.
your family members. It is intended to
What if I don’t have the procedure?
highlight some of the important points of what
we have discussed with you in the office. Please
There is little information that says this type of
feel free to ask us any questions so you can
treatment is better at curing prostate cancer
make the best decision regarding your
than surgery or radiation therapy. We
treatment.
recommend this procedure when the cancer is
still confined to the prostate (unless it is a
salvage procedure) and is based on a
combination of the following depending on
your specific circumstances:

Your PSA (prostate blood test) value;

How the prostate feels upon
examination;

The biopsy grade of the cancer; this
is a scoring system called the
Gleason Score that is used to
determine how aggressive a tumor
may be;

A bone scan (x-ray of the skeleton)
if it is indicated;

A CT scan or MRI (magnetic
resonance imaging) when indicated;
these tests are not very accurate at
telling us if the cancer is local or has
spread.
You may choose radiation or surgery as an
alternative. You may also choose to do no
intervention and control your symptoms with
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