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 10 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 randomised controlled trials (also included in the systematic review), 1 non-randomised comparative study (also included in the systematic review), 2 case series, 3 case reports, and data provided by the UK-ROPE register and 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: quality of life, urinary symptoms as measured by the International Prostate Symptom Score, and improvement in urodynamics.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: inadvertent embolisation of other sites, urinary retention, prostatic bleeding (haematuria and haematospermia), groin haematoma, pain, retrograde ejaculation, and no loss of sexual function.