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 11 sources, which was discussed by the committee. The evidence included 1 systematic review, 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 (described in 2 publications and 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.
3.5 Most of the published evidence was from people with small- to medium-sized prostates, but there is emerging evidence from people with larger 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 cause less sexual dysfunction than some of the other procedures used to treat lower urinary tract symptoms caused by benign prostatic hyperplasia.