Yes. HIFU has been approved by the FDA in the United States. We are currently negotiating coverage nationwide, and we will update our site as physicians begin treating patients. Please contact us for more information.
If you or a loved one is interested in the HIFU system, please call one of our HIFU experts toll free at (941) 444-1441. You may also fill out the contact form on the side of this page, and one of our experts will contact you shortly to discuss your options. Treatment can generally be arranged within a couple of weeks.
If you have an enlarged prostate (greater than 40 cc/grams), you may require pretreatment debulking by drug therapy or transurethral resection of the prostate (TURP). The size of the prostate is measured by ultrasound at the time of the biopsy.
Patients with a history of cardiac health problems can still qualify for HIFU, even though they may not qualify for surgery. Patients will be asked to provide blood work, an electrocardiogram, and a cardiologist consultation prior to treatment.
No, this will not interfere with this treatment option. Typically, someone who is insulin dependent is treated as the first case of the day.
Yes, we have a third party that arranges financing. We will put you in touch with them and they will make arrangements with you, independent of HIFU solution.
At the time, this procedure is self-pay. We will work with you to discuss your options with your insurance company, and they may or may not pay a portion of the cost. The procedure has been approved by the FDA in the United States, therefore it is available.
You will have to discuss this with your accountant.
With the HIFU treatment plan, no overnight stay is required. However, since you will be administered anesthesia, you are required to travel with someone due to sedation.
There are two companies: Sonacare medical located in North Carolina, a US company and EDAP, a French company.
This is an outpatient procedure, and it requires no overnight stay.
The treatment usually ranges from one to three hours depending on the size of your prostate and your specific situation.
HIFU treatment completely destroys the prostate tissue and cancer cells, which reduces them to protein debris and non-viable tissue. Some of this tissue is re-absorbed by the body’s natural mechanisms and some of this tissue is removed through the urinary tract.
The first HIFU treatment was performed in the 1990s. There have been several technological advancements since then, which took an already safe procedure and made it safer with less side effects.
Some of the common medications that need to be discontinued include: -Aspirin including baby aspirin -Xarelto -Eloquis -Plavix (Clopidogrel) -Coumadin (Warfarin) -Ticlid (Ticlopidine) -Herbal products and vitamins *some herbal products and vitamins have blood-thinning components, so it is necessary to discontinue use.
Yes, anesthesia is required. Your anesthesiologist will decide what is best for you. Since there is no cutting off body tissue and no loss of body fluids, anesthesia is light. Many patients breathe on their own.
Yes. You will need to be on an antibiotic while you have a catheter due to the fact that there is a small risk that it can cause a urinary tract infection. You will also be given a prescription to reduce spasms, which can occur for a brief time after treatment. To alleviate pelvic cramping, sitting in a tub of warm water is helpful. You will also be given Flomax or a similar drug a few days before having your catheter removed to assist with voiding. Most patients usually do not need pain medications after this treatment.
There is no medical procedure that is 100% guaranteed, therefore some patients do require repeat treatment. The advantage of using HIFU is that it does not limit any future treatment options. Should treatment be necessary again, HIFU can be repeated or a patient can choose surgery or radiation. Surgery and radiation cannot be repeated, though.
This procedure takes place in a surgery center. We have established surgery centers at each site where the machines are located in the United States.
Yes, hormone therapy is not a contradiction to HIFU.
Patients usually don’t need pain medication after this procedure.
The rectal probe looks much larger than the standard biopsy/ultrasound probe. Is that why the anesthesia is required?
The procedure is completed under anesthesia which is required so the patient remains comfortable and still throughout the treatment. If the machine detects any movement, treatment stops immediately, so it is very important that you remain still. The rectal probe is not much larger than the standard biopsy/ultrasound probe.
A catheter will be required for 5-14 days following treatment as there will be swelling and edema of the treated prostate. Duration varies based on size of prostate and whether it was on one side or both sides. After the HIFU procedure, the destroyed prostate tissue is passed through the urine. It is possible that you will see sloughed material and possibly blood in the catheter bag. This is normal. The catheter can be removed by the patient’s home health nurse or physician.
Some patients do require catheters longer than 14 days. This is more common in men with larger prostates and in men who experience voiding difficulty prior to treatment. Unfortunately, it is difficult to predict in advance, therefore reinsertion is sometimes necessary. If reinsertion is required, it is important that it is left in place for several days.
This timeframe varies. Typically, 14 days is the most appropriate timeframe, but it is a process of trial and error.
Yes. Although, you will not be able to drive with the catheter on the day of the treatment due to your anesthetic. The catheter may be a little uncomfortable to begin with, but sitting as a passenger is not a problem
I have no problems urinating other than the fact that the stream is small, steady, and it takes much longer. Will the stream get stronger as the healing process continues?
After the procedure, swelling is very likely, which can lead to reduced stream lasting up to several weeks. If the stream continues to be of a reduced nature, treatment may be necessary due to ongoing sloughing of the prostate tissue.
It is recommended for patients with large prostates or those that have significant difficulty and straining before the procedure to undergo laser or TURP. This is to avoid the need for wearing a catheter due to sloughing of tissue. Discuss with your physician.
Urinary incontinence is classified as grade 1, 2, or 3 depending on severity of the incontinence. Grade 1 is minimal stress incontinence which occurs only occasionally and occurs with severe straining. Grade 3 is severe or complete incontinence. After HIFU, Grade 1 incontinence occurs in less than 5% of cases. Grade 2 and 3 incontinence are very rare after HIFU occurring in less than 1% of cases performed as the primary treatment for prostate cancer. After failed radiation therapy or failed brachytherapy (radioactive seeds) up to 8% of patients will have Type 3 incontinence following salvage therapy with HIFU. These rates for treatment of primary prostate cancer and for treatment after failed radiation therapy and failed brachytherapy are both considerably better than for treatment with surgery or cryotherapy.
Stressful activities that increase abdominal pressure, such as heavy lifting, can lead to leakage. This type of incontinence can be eliminated by Kegel exercises. The most severe type of incontinence may require use of incontinence pads, but is very rarely a problem with HIFU.
This can be prevented by a nerve sparing treatment procedure. As with other procedures, HIFU is NOT 100% guaranteed to provide these results, but results are as good as nerve-sparing procedures. Many patients experience temporary erectile difficulties, and it is not possible to predict what the final result may be for several months post treatment.
The HIFU probe consists of two probes, one within the other. The imaging probe is high quality and it demonstrates the neurovascular bundle which contains the nerves of erection. The entire length of the bundle can be seen throughout it and can avoid damaging nerves. Sometimes we can treat one side of the nerve bundle in early stages, which could prevent erectile dysfunction.
I was told that my erectile function may come back after a certain amount of time, but that I may need Viagra or Cialis for a while. Approximately how long will it take for the damaged nerves to repair themselves?
Several months, and even up to one year, are required before outcomes can be evaluated, even though the injured nerves may regenerate quicker. Studies show that Viagra, Levitra, Cialis, etc. may assist in the healing process by increasing blood flow to the area. Therefore, you may wish to begin taking these medications twice a week once your catheter is removed to assist with the quality of erectile function.
The nerves in neuromuscular bundles are what control erections. Precise localization of these bundles allows treatment within 2 to 3 mm of them. This technique is designed to preserve potency while also eliminating all cancer. The nerve sparing procedure can only be performed on prostates which have biopsies that are negative for cancer in the lobe of the gland where the nerve sparing procedure is performed.
If I were to have HIFU with a nerve sparing procedure and there was a recurrence, is it possible to have a radical prostatectomy with a nerve sparing procedure?
If a recurrence were to happen, HIFU would be the ideal treatment option. Surgery would be an option, but it would be much more difficult. Any time you combine treatment you lower the possibility of sparing nerves. If a recurrence were to happen, it is possible to try to save the nerves, but it is very likely that it would not be successful.
No, this would not affect HIFU. Surrounding the nerve bundles is an open space that acts as a free passage for cancer cells to grow. The presence of cancer cells in the “perineural space” is one of the factors used in making the diagnosis of prostate cancer (benign tissue will not get into that space). This does not indicate that the cancer has spread outside of the prostate (lymph nodes) but it does suggest that the cancer has been present for a longer period of time. These nerves have nothing to do with erectile function so it does not interfere with the nerve sparing technique. The main nerves for erections are outside of the prostate in the neurovascular bundles.
The goal of most prostate cancer treatments is to destroy all prostate tissue. If the entire prostate is not destroyed, there is a slight chance that a new tumor could develop or a recurrence could happen.
Biopsies are only necessary if the PSA continues to be elevated or rising continuously. A repeat TRUS (trans-rectal ultrasound) will be required to visualize any remaining or recurrent prostate cancer and biopsy of the tissue will be performed. The biopsy is conducted on the scar tissue that is left behind. Negative biopsies indicate that cancer is no longer present.
A normal PSA is approximately 3.5 ng/ml. There have been studies that show that this may rise with age. Even more important than the actual PSA level is the rate of increase of PSA year after year. If you notice a rate of increase greater than 0.5, than you should discuss having a biopsy performed with your doctor.
If my prostate cancer has a Gleason score of 8 or greater, will I need to have my seminal vesicles treated?
No, there is no evidence that treatment of the seminal vesicles will alter the course of your prostate cancer.
Most of our doctors have treated many cases of HIFU and have been certified for using the technology. Some physicians have done over 100 cases. If any doctor needs more experience, he will be proctored by an experienced HIFU physician to make sure the procedure is done accurately.
HIFU is relatively new in the United States, but it has been approved by the FDA as a safe and effective method treating prostate cancer. Thousands of treatments have been performed worldwide and the results have been published in worldwide peer-reviewed medical journals. Please contact us if you would like to review the peer-reviewed articles.