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HIFU - Frequently Asked Questions
What is HIFU?

HIFU stands for High Intensity Focused Ultrasound. HIFU is a non-invasive acoustic ablation technique that uses intersecting, tightly focused ultrasound waves to raise the temperature of the target tissue to more than 80-90 degrees Celsius in two to three seconds, effectively destroying the targeted tissues.

HIFU is a non-invasive therapy device that is approved in Europe, parts of Asia, and Central America for the treatment of localised prostate cancer and benign prostatic hyperplasia (BPH) or prostate enlargement.

 

How does it work?
Using intersecting tightly focused ultrasound waves, the HIFU device destroys tissue and leaves surrounding cells untouched. In addition to being non-invasive (no incisions or punctures), HIFU energy is non-ionizing clean energy that can be applied repeatedly without damaging other tissue, unlike radiation based therapies. HIFU technology allows a physician to see a live image of the prostate, then target and ablate the entire prostate without affecting the surrounding tissue.

HIFU energy works like a magnifying glass and sunlight. Using a magnifying glass you can focus energy of the sun and concentrate it over a focus point while allowing safe and harmless energy transfer over the entire course of that beam up until it reaches the point of concentration.

 

What equipment is used?
The HIFU treatment is performed using a Sonablate® 500 which is manufactured by Misonix Inc. (NASDAQ: MSON) of Farmingdale, New York.

  • The Sonablate® 500 is approved in many countries outside the U.S. as an image-guided acoustic ablation device developed by Focus Surgery to treat prostate disease.
  • The technology behind the device originated at the Indiana University School of Medicine in Indianapolis in the 1970's. It was further developed in leading research centres across the globe.
  • In 2001, the Sonablate® 500 received its CE Mark for European distribution and its MHW approval for Japan.
  • Recent studies in Europe have shown that in 88% of the patients studied, HIFU technology produced PSA measurements below 1.0 within one year following treatment with a lower incidence of erectile dysfunction and urinary incontinence than reported in studies of other therapies.
  • The Sonablate® 500 allows a trained urologist to visualise the prostate and plan and monitor the treatment in real time, ensuring maximum precision, flexibility, safety and control for the clinician.

 

What are the results of HIFU treatment?
In approved countries, 88-99% of patients have PSA less than one after one year. Treatment may be repeated as necessary. Recently the Journal of Urology published an article authored by Dr Wieland and Dr Blanna from the University of Gegensburg (Germany). The study included patients with a five-year follow-up and showed 93.4% constant negative biopsies in the patient population and with only two patients having a PSA level that rose to greater than four. Publications by Dr Toyoaki Uchida, M.D., from Tokai University Hospital and John C. Rewcastle, PhD from the Department of Radiology, University of Calgary in Canada reported very similar positive findings.

 

What are the benefits of HIFU treatment?
Real time imaging and treatment of the prostate with HIFU offers the possibility of very low rates of erectile dysfunction and negligible rates of incontinence. Neurovascular structures responsible for erectile and continence can be imaged, and the treatment can be designed to avoid treatment of these sensitive areas. The precise results of clinical studies depend on the surgical protocol adopted by the researchers, but an overall average assessment is the less than 20% of men will have erectile dysfunction and in a recent data series from Dr Uschida, less than 1% of men had an incontinence problem. It is likely that with the technology now available, the rates of erectile dysfunction in patients treated in prospective studies, will be considerably lower.

HIFU is delivered using an epidural anaesthetic (or a general anaesthetic if chosen) and is an out-patient procedure. There is no radiation or cuts, and it is a pain-free procedure.

What is the recovery time?
Recovery involves wearing a Foley catheter for a week and patients usually can return to a normal lifestyle almost immediately after the two to four hour procedure.

What are the side effects?
Erectile dysfunction can occur in some men. Incontinence is uncommon. Urethral strictures, epididymitis, and rectourtheral fistulas are rare.

Who can be treated?

  • Men who have been diagnosed with T1 or T2 carcinoma of the prostate.
  • Men under 80 years of age.
  • Men with a life expectancy of five or more years.
  • Men who have had fewer than seven core prostate biopsies.
  • Men with Gleason score 7.
  • Men with a serum PSA less than 20ng/ml.
  • Men with a prostate volume less than 40cc.

Who cannot be treated?

  • Men with evidence of metastatic disease.
  • Men with an inability to tolerate a transrectal ultrasound.
  • Men with latex allergies.
  • Men with any active urinary tract infection.
  • Men with functional bladder problems.
  • Men with intraprostatic calcifications over 1cm in size.
  • Men over 80 years of age.

Who performs the procedure?
Mr Mark Emberton, Senior Lecturer in Oncological Surgery, Institute of Urology, University College Hospital, London, and Director of the Clinical Effectiveness Unit, Royal College of Surgeons. Five other surgeons are being trained, including Mr Simon Brewster at Oxford Churchill Hospital and Mr Henry Lewi at Springfield Hospital, Chelmsford.

What should I do next?
Contact Mr. Lewi's secretary (Mrs. Esther Kendall) on 01245 234087 to arrange an outpatient appointment or email Mr. Lewi on for further information. Sister Sarah Buttle (Urology Specialist Sister) is also available for advice on 07905 428836 or via the secretary on 01245 234087.

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