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08 October 2014

NICE consults on plans to support new device for surgery on enlarged prostate glands

NICE is asking for views on its plans to support a new surgical system for reducing the size of enlarged prostate glands in men.

In the consultation which opens today, NICE draft medical technology guidance provisionally supports the use of the TransUrethral Resection in saline (TURis) system. This device, which is similar to an endoscope with a diathermy wire in front of the camera, uses a bipolar electrosurgery system to cut away or vaporise excess prostate tissue. Using the TURis system reduces the need for blood transfusion, and the length of hospital stay and rates of hospital readmission may also be reduced.  The device also eliminates TUR syndrome – a rare but serious complication of prostate resection, which can occur with monopolar electrosurgery.  The draft guidance estimates that savings of up £375 per patient could be made using this system.

Prostate enlargement is a common condition in older men – around 60% of men aged 60 or over have some degree of prostate enlargement. The enlarged prostate gland may press on the urethra and so can make passing urine more difficult.  The condition doesn’t pose other direct risks to health, but complications of a blocked urine tract include severe urinary tract infections, urinary retention or renal failure.  Surgery is offered when problems passing urine are severe, or if drug treatment and conservative management options have been unsuccessful or are not appropriate.  Approximately 15,000 prostate resection procedures are carried out each year in England and Wales.

In electrosurgery, the tool that the surgeon uses to cut tissue has an electric current running through it which seals the cut and so reduces bleeding. To complete the electrical circuit, a return electrode is needed. The TURis system’s bipolar design has an internal return electrode within the device which means that a return electrode does not need to be stuck onto the patient’s skin.  Also, unlike monopolar electrosurgery, the bipolar TURis system doesn’t use glycine to flush out blood and debris from the urethra, which therefore avoids any risk of a problem called TUR syndrome.

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation, said: “The problems caused by an enlarged prostate gland affect many men as they get older. The supportive provisional recommendation for the TURis system advises that it should be considered for use in patients where surgery is needed because of  severe symptoms associated with an enlarged prostate. The evidence examined by the independent Medical Technologies Advisory Committee indicates that as well as benefiting patients by reducing the need for blood transfusion, it’s also likely to benefit the NHS by saving money.  We welcome comments on the draft guidance as part of the current consultation.”

More information on the medical technology draft guidance consultation for the TURis system  is available at http://www.nice.org.uk/guidance/indevelopment/GID-MT217. The consultation closes on 5 November 2014. 

ENDS

For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142, or out of hours on 07775 583 813.

Notes to Editors

About the NICE guidance

  1. The TURis system (TransUrethral Resection in saline) is manufactured by Olympus Medical.
  2. The potential for savings per patient from modelling suggests that the TURis system saves £375 per patient for hospitals with existing Olympus equipment and £285 per patient for other hospitals, when compared with current options.
  3. The Committee noted there was clinical evidence showing that use of the TURis system eliminates TUR syndrome and reduces patients’ need for blood transfusion compared with monopolar transurethral resection of the prostate (TURP). TUR syndrome is a rare but potentially fatal complication of TURP surgery when monopolar electrosurgery is used, occurring in around 1 in 100 procedures. During monopolar TURP, glycine is used to clear the urethra of blood and debris. When glycine is absorbed into the bloodstream, it can cause a potentially dangerous build-up of fluid in the circulation, leading to fluid overload and hyponatraemia (low sodium level in the blood). The TURis system does not use glycine which removes the risk of this complication.

About the Medical Technologies Evaluation Programme

  1. The Medical Technologies Evaluation Programme focuses specifically on the evaluation of innovative medical technologies, including devices and diagnostics. The types of products which might be included are medical devices that deliver treatment such as those implanted during surgical procedures, technologies that give greater independence to patients, and diagnostic devices or tests used to detect or monitor medical conditions. The independent Medical Technology Advisory Committee has two core remits: selecting medical technologies for evaluation by NICE guidance programmes and also developing medical technologies guidance itself. The guidance applies to the NHS in England, and is not mandatory.

More information is available at http://www.nice.org.uk/MT.

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

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"The supportive provisional recommendation for the TURis system advises that it should be considered for use in patients where surgery is needed because of severe symptoms associated with an enlarged prostate."

Professor Carole Longson, Director of the NICE Centre for Health Technology Evaluation