How are you taking part in this consultation?

You will not be able to change how you comment later.

You must be signed in to answer questions

    The content on this page is not current guidance and is only for the purposes of the consultation process.

    3 Committee considerations

    The evidence

    3.1 NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 9 sources, which was discussed by the committee. The evidence included 1 pooled analysis of 4 trials, 1 randomised controlled trial (described in 2 publications and also included in the pooled analysis), 1 prospective multicentre single-arm trial (also included in the pooled analysis), 1 retrospective cohort study, 1 retrospective non-randomised comparative study, 2 retrospective case series, and a report from the US Food and Drug Administration Manufacturer and User Facility Device Experience database. The evidence is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in table 5 of the overview.

    3.2 The professional experts and the committee considered the key efficacy outcomes to be: reduction in lower urinary tract symptoms and preservation of sexual function, including ejaculatory function.

    3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, damage to adjacent structures, need for reintervention, urinary incontinence and urinary retention.

    3.4 Patient commentary was sought but none was received.

    Committee comments

    3.5 Most of the evidence was from small- to medium-sized prostates.

    3.6 The procedure has evolved over time. Additional electrosurgery at the end of the procedure is now commonly used to reduce the risk of bleeding.

    3.7 The committee was told that this procedure may produce less sexual dysfunction than some of the other procedures used to treat lower urinary tract symptoms caused by benign prostatic hyperplasia.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    April 2023

    ISBN: