3.1 To inform the committee, 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 8 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial (reported in 3 separate studies), 1 prospective single arm trial, 3 case series and 1 additional study that reported pooled results from the randomised controlled trial and the single arm trial. This evidence is presented in table 2 of the interventional procedures overview. Other relevant literature is in the appendix of the overview.
3.2 The specialist advisers and the committee considered the key efficacy outcomes to be: improvement in lower urinary tract symptoms and quality of life, improved urinary flow rate and preservation of sexual function.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: bleeding, incontinence, injury to adjacent organs.
3.4 Five commentaries from patients who had experience of this procedure were received, which were discussed by the committee.
3.5 It is possible to collect tissue for histological analysis during this procedure.
3.6 The committee noted that in the 1 randomised trial included in the evidence review, patients who had this procedure were more likely to preserve their existing sexual function compared with patients who had transurethral resection of the prostate.