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).

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.

Insertion of a suprapubic catheter is a standard urological procedure. Side effects which could be associated with this procedure may include:

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.