Interventional procedure consultation document - KTP laser (60-80W) vaporisation of the prostate

The National Institute for Clinical Excellence is examining KTP laser (60-80 W) vaporisation of the prostate and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about KTP laser (60-80 W) vaporisation of the prostate.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendations made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedure Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 25 November 2003

Target date for publication of guidance: March 2004

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.

Current evidence on the safety and efficacy of KTP (potassium titanium oxide phosphate) laser (60-80 W) vaporisation of the prostate does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake KTP laser (60-80 W) vaporisation of the prostate should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. Use of the Institute's Information for the Public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.

Clinicians undertaking this procedure should have adequate training before performing the technique. NICE has asked the British Association of Urological Surgeons to produce standards for training.

The procedure

Indications

Benign prostatic obstruction (BPO) is a non-malignant enlargement of the prostate and is a common cause of lower urinary tract symptoms (such as difficulty in passing urine) in men aged over 40 years.

Prostatic obstruction can be managed medically or surgically. The standard surgical treatment is transurethral resection of the prostate (TURP). However, relatively high morbidity from this procedure has led to the development of a range of less invasive techniques, some of which utilise endoscopic laser.

This procedure involves the application of high-power (60-80 W) KTP laser energy to the prostatic tissue. Under spinal anaesthesia a small flexible fibre optic is inserted through a cystoscope into the urethra. Light pulses are then sent through this fibre, vaporising and removing the obstructing prostatic tissue. A urethral catheter may be left in place after the procedure.

In two uncontrolled studies that reported on 12 months' follow-up in a total of 46 patients, there was an 82-89% improvement in the American Urological Association Symptom Score (AUA score), and a 198-255% mean increase in the peak urinary flow rate. There was also some indication that patients' quality of life was improved. For more details, refer to the Overview (see Appendix).

The Specialist Advisors noted the importance of training in this procedure. They suggested that efficacy may be related to the experience of the surgeon. One Advisor commented that lack of experience in this procedure could leave patients with inadequate prostate removal, resulting in the need for further surgery.

The most commonly reported complication was mild transient dysuria (difficult or painful passage of urine). Other complications included haematuria, retrograde (abnormal) ejaculation and soft bladder-neck contracture, which was experienced by one patient in a study of 55 patients. For more details, refer to the Overview (see Appendix).

The Specialist Advisors listed potential adverse events as inflammation, pain, urinary retention, retrograde ejaculation, incontinence and infection. They noted that patients were likely to suffer irritative bladder symptoms in the early postoperative period.

There was a lack of long-term data.

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making it's provisional recommendations.

• Interventional Procedure Overview of KTP laser (60-80W) vaporisation of the prostate, June 2003

Available from: www.nice.org.uk/ip189overview