Potential
Side Effects
If you agree to this procedure, the treatment you receive with the Sonablate
will involve HIFU energy being activated to destroy selected prostate tissue.
The risk of this treatment includes, but is not limited to, the following side
effects:
Common Side Effects:
- Proteinuria (protein in the urine)
- Pain in the treatment area (rectum
or scrotum area)
- Sudden, complete inability to urinate
- Dysuria (difficulty with urination)
- Urinary tract infection (UTI)
- Epididymitis (pain, swelling and
tenderness in the scrotum)
- Prostatitis (infection of the prostate)
- Hematospermia (blood in the semen
or ejaculation fluid)
- Hematuria (blood in the urine)
- Retrograde Ejaculation (passing
of semen back into the bladder instead of out of the penis
upon ejaculation)
- Urinary Incontinence (leakage of
urine)
Less Common Side Effects (These may be more severe):
- Urethral stricture, bladder neck
contracture (a narrowing of the tube from the bladder to
the outside of the body, either near the bladder or at another
point)
- Rectal wall injury and / or rectal
fistula (an abnormal hole in the rectum)(see below)
- Rectal incontinence (leakage of
stool)
- Possible return of your cancer
after treatment
During the HIFU treatment, there is also a risk of damage to the rectal wall
(rectal fistula) from the heat generated from the treatment. This risk is
minimized (lessened) by constant monitoring of the temperature in the probe
tip and by the use
of a cooling device to control the temperature of the probe tip. However,
it cannot be avoided completely. Patients who have had previous radiation
treatment for prostate cancer are at higher risk for rectal fistula. As with
most prostate cancer treatments, there is also a risk of impotence (the inability to have an erection).
Risks
Associated With Anesthesia
Anesthetics are commonly used for the relief and protection from pain during
the planned HIFU procedure and possible additional procedures. The use of anesthesia
involves additional risks and hazards of its own separate and apart from the
risks associated with HIFU. Certain
complications or side effects may result from spinal, general or epidural anesthetics,
including but not limited to headache, sore throat, inhaling (breathing in)
stomach contents, chronic pain, failure to relieve pain, drug reaction, and
other life threatening events that will be explained to you by the anesthesiologist before your procedure. In addition, the type of
anesthesia used may have to be changed possibly without explanation to you
during the course of the procedure if your anesthesia doctor feels this is
in your best interest.
Risks Associated with the Suprapubic Catheter
Insertion of a suprapubic catheter is a standard urological procedure. Side
effects which could be associated with this procedure may include:
Minor discomfort where the catheter passes through the skin;
Urinary tract infection (UTI);
and (Rarely) damage to the inside of the bladder.
Risks
Associated With Screening and Follow-Up Procedures
There may be some risks related to the test procedures, which are part of the
preparation for the procedure and post-operative care and follow-up. All of
the tests performed prior to and after the procedure and follow up visits are
commonly performed urologic examinations. During pre and post-treatment care,
blood will be taken from you for laboratory analysis. The approximate amount
of blood that will be taken at one visit is 2-3 teaspoons. Some of the risks
associated with drawing blood include pain, bruising and rarely infection.
More comprehensive information about the risks, and answers to any questions
you may have, will be available from the doctor or his or her staff at the
time of the pre- and post-treatment procedures. Along with the possible risks
listed here, there may be others that we do not yet know about. These risks
may or may not be related to the use of the HIFU device.
If you have questions about these risks listed above, please ask your Treating
Physician to explain them to you.
