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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    Validity and generalisability of the studies

    • Studies included patients from North America, Europe (including the UK) and Asia.

    • There is a randomised single-blinded controlled trial, which used a sham control, with a 12-month follow up (Chughtai, 2021). Although there was a relatively high dropout rate in the trial, the proportion of dropouts were similar in the treatment and control groups.

    • The randomised controlled trial showed a strong placebo effect associated with the procedure.

    • Inclusion criteria varied between the studies, particularly regarding prostate volume.

    • One study used a first generation device (Porpiglia et al., 2018) and the other 3 used a second generation device.

    • The longest reported follow up was 3 years.