The National Institute for Health and Care Excellence (NICE) issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland August 2017. NICE is currently updating this guidance. The new guidance will be published shortly. Until then the NHS should continue to follow the recommendations outlined in the current version of the guidance. The Interventional Procedures Advisory Committee (IPAC) will consider this procedure review and NICE will issue an interventional procedures consultation document about its safety and efficacy for 4 weeks’ public consultation. IPAC will then review the consultation document in the light of comments received and produce a final interventional procedures document, which will be considered by NICE before guidance is issued to the NHS in England, Wales, Scotland and Northern Ireland.
Status Awaiting development
Technology type Procedure
Decision Selected
Reason for decision Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources
Process IP
ID number 1316
Description Radiotherapy for prostate cancer can cause rectal damage because of the close proximity of the prostate and the rectum. Symptoms include diarrhoea, incontinence, proctitis and ulceration of the rectal mucosa. Injecting a biodegradable substance (examples include polyethylene glycol hydrogel, hyaluronic acid, and human collagen), or inserting and inflating a biodegradable balloon spacer, in the space between the rectum and prostate is done to temporarily increase the distance between them. The aim is to reduce the amount of radiation delivered to the rectum and reduce the toxicity profile during prostate radiotherapy. The procedure is usually done with the patient under general anaesthesia using transrectal ultrasound guidance, but it may also be done using local or spinal anaesthesia. The patient is placed in the dorsal lithotomy position. For gel injection, a needle is advanced via a transperineal approach into the space between the prostate and the rectum. Hydrodissection with saline is then used to separate the prostate and the rectum. Following confirmation of the correct positioning of the needle, the hydrogel precursors are injected, filling the perirectal space; these then polymerise to form a soft mass. The biodegradable hydrogel absorbs slowly over several months. For balloon spacer insertion, a small perineal incision is typically used to insert a dilator and introducer sheath. The dilator is advanced towards the prostate base over the needle, which is then removed. A biodegradable balloon is introduced through the introducer sheath and is filled with saline and sealed with a biodegradable plug. The balloon spacer degrades over several months.

Provisional Schedule

Expected publication 17 August 2022

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Key events during the development of the guidance:

Date Update
09 June 2022 Committee meeting: 2
04 May 2022 Awaiting development. Status change linked to Topic Selection Decision being set to Selected
01 February 2022 - 01 March 2022 Interventional procedure consultation
11 November 2021 Committee meeting: 1
12 November 2020 Topic selection. IPAC 0

For further information on how we develop interventional procedures guidance, please see our IP manual