Prostate artery embolisation for benign prostatic Issued: April 2013 guidance.nice.org.uk/ipg NICE has accredited the process used by the NICE Interventional Procedures Programme to produce interventional procedures guidance. Accreditation is valid for 5 years from January 2010 and applies to guidance produced since January 2009 using the processes described in the 'Interventional Procedures Programme: Process guide, January 2009' and the 'Interventional Procedures Programme: Methods guide, June 2007'. More information on accreditation can be viewed at www.nice.org.uk/accreditation NICE 2013
1 Guidance 1.1 Current evidence on the safety and efficacy of prostate artery embolisation for benign prostatic is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. 1.2 Prostate artery embolisation for benign prostatic should only be undertaken following consideration of the patients by a multidisciplinary team that includes a urologist and an interventional radiologist. 1.3 Further research in the form of randomised trials or cohort studies (for example, using an appropriate register) should clearly document patient selection criteria and all complications, specifically including disturbance of sexual function. Efficacy outcomes should include measures of urinary function, symptoms and quality of life. Information about longer-term outcomes, including the need for further treatment, would be valuable. 1.4 NICE may review the procedure on publication of further evidence. 2 The procedure 2.1 Indications and current treatments 2.1.1 Benign prostatic is a common condition in men. Its incidence increases with age. It is characterised by an enlarged prostate, caused by an increased number of stromal and epithelial cells. Symptoms include a poor stream of urine, urinary frequency, urgency, leaking or dribbling, and urinary retention. 2.1.2 Mild symptoms can be treated by medical therapy to relax the smooth muscle of the prostate and bladder neck, reduce prostate size or prevent further enlargement. 2.1.3 When medical treatment is inadequate, patients may be treated surgically. Current surgical treatments include transurethral resection of the prostate, laser surgery, transurethral electrovaporisation and open prostatectomy. NICE 2013. All rights reserved. Last modified April 2013 Page 2 of 6
Surgical intervention carries a risk of complications including bleeding, infection, strictures, incontinence and sexual dysfunction. 2.2 Outline of the procedure 2.2.1 The aim of prostate artery embolisation for benign prostatic is to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage. 2.2.2 The procedure is usually performed with the patient under local anaesthetic and sedation. Using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is done using microcatheters. Embolisation involves the introduction of microparticles to block these small prostatic arteries. Embolisation agents include polyvinyl alcohol (PVA), gelatin sponge and other synthetic biocompatible materials. Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview. 2.3 Efficacy 2.3.1 A case series of 47 patients reported a 19.4 point improvement in mean International Prostate Symptom Score (IPSS) from 24.2 at baseline to 4.8 after prostate artery embolisation (p value not reported, follow-up ranged from 7 days to 2 years). A case series of 15 patients reported a 6.5 point improvement in mean IPSS from 21.0 at baseline to 14.5 after the procedure (n=8, p=0.005) at a mean follow-up of 8 months. 2.3.2 The case series of 47 patients reported that mean prostate volume reduced by 42% from 117 ml to 68 ml after prostate artery embolisation (p value not reported, follow-up ranged from 7 days to 2 years). The case series of 15 patients reported a mean reduction in prostate volume assessed by ultrasound of 27% (from 97 ml to 71 ml, measured in 14 patients, p=0.0001) and by MRI of 28% (from 105 ml to 76 ml, measured in 9 patients, p=0.008) at a mean follow-up of 8 months. NICE 2013. All rights reserved. Last modified April 2013 Page 3 of 6
2.3.3 The case series of 47 patients reported an increase in mean maximum urinary flow rate (Q max ) of 97% (from 9.6 ml/s to 18.9 ml/s) after prostate artery embolisation (p value not reported, follow-up ranged from 7 days to 2 years). The case series of 15 patients reported an increase in mean Q max of 54% (from 7.1 ml/s to 10.9 ml/s) after the procedure (n=8, p=0.015, mean follow-up of 8 months). 2.3.4 The case series of 47 patients reported a reduction in mean post-void residual urine volume from 184 ml to 3 ml (p value not reported, follow-up ranged from 7 days to 2 years). The case series of 15 patients reported a mean reduction in post-void residual urine volume from 130.8 ml at baseline to 51.3 ml after prostate artery embolisation (n=8, p=0.0004, mean follow-up 8 months). 2.3.5 The Specialist Advisers considered key efficacy outcomes to include improved IPSS scores (including quality of life), satisfactory erectile function scores using the International Index of Erectile Function questionnaire, improved voiding, reduced prostate size and reversal of acute retention of urine. 2.4 Safety 2.4.1 Ischaemia of a small area of bladder wall was reported in 1 patient in the case series of 15 patients: treatment was by surgical excision of the affected area. 2.4.2 Urinary tract infection was reported in 2 patients in the case series of 15 patients: these were treated with antibiotics. 2.4.3 Acute urinary retention after the procedure needing catheterisation was reported in 1 patient in the case series of 15 patients. 2.4.4 The Specialist Advisers listed additional anecdotal adverse events as transient rectal bleeding, retro-pubic pain, haematuria, haemospermia, proctalgia and balanoprostatitis. They listed theoretical adverse events as inadvertent embolisation and subsequent infarction (and possibly gangrene) of adjacent organs, such as the bladder and possibly the rectum, damage to the cavernosal artery and erectile dysfunction, damage to the external urethral sphincter and incontinence, arterial pseudo-aneurysm, urinary fistula, prostatic NICE 2013. All rights reserved. Last modified April 2013 Page 4 of 6
abscess, haematomas, dysuria, and worsening benign prostatic symptoms. They also listed a low theoretical risk of cancer if there is prolonged radiation exposure during the procedure. 2.5 Other comments 2.5.1 The Committee noted that potential benefits of prostate artery embolisation over surgery might include reduced morbidity and avoidance of a general anaesthetic. 3 Further information 3.1 For related NICE guidance see the NICE website. Information for patients NICE has produced information on this procedure for patients and carers (Information for the public). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind. About this guidance makes recommendations on the safety and efficacy of the procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions are taken by local NHS bodies after considering the clinical effectiveness of the procedure and whether it represents value for money for the NHS. It is for healthcare professionals and people using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare Improvement Scotland for implementation by NHSScotland. This guidance was developed using the NICE interventional procedures guidance process. We have produced a summary of this guidance for patients and carers. Your responsibility This guidance represents the views of NICE and was arrived at after careful consideration of the NICE 2013. All rights reserved. Last modified April 2013 Page 5 of 6
available evidence. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of healthcare professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Copyright National Institute for Health and Care Excellence 2013. All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE. Contact NICE National Institute for Health and Care Excellence Level 1A, City Tower, Piccadilly Plaza, Manchester M1 4BT www.nice.org.uk nice@nice.org.uk 0845 033 7780 ISBN 978-1-4731-0122-7 NICE 2013. All rights reserved. Last modified April 2013 Page 6 of 6