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 1 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. 2 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 3 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 4 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 5