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    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 4 sources, which was discussed by the committee. The evidence included 1 randomised controlled trial and 3 single-arm trials. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in the appendix of the overview.

    3.2 The professional experts and the committee considered the key efficacy outcomes to be: improved quality of life, reduced lower urinary tract symptoms, improved urinary flow and reduced postvoid residual volume.

    3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, pain, infection, urinary incontinence and need for reintervention.

    3.4 Patient commentary was sought but none was received.

    Committee comments

    3.5 The committee noted that there:

    • is only 1 device for this procedure and the technology is evolving

    • was a sizeable placebo effect associated with the procedure in some of the studies.

    3.6 The committee was informed that the procedure may benefit more people with smaller prostates and well-functioning bladders.

    Tom Clutton-Brock
    Chair, interventional procedures advisory committee
    March 2022

    ISBN: