Guidance
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, reduced postvoid residual volume and preservation of sexual function.
3.3 The professional experts and the committee considered the key safety outcomes to be: bleeding, pain, infection and need for reintervention.
3.4 Patient commentary was sought but none was received.
Committee comments
3.5 The committee noted that:
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there is only 1 device for this procedure and the technology is evolving
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there was a sizeable placebo effect associated with the procedure in 1 study
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the procedure is associated with expected, short-term, mild, transient and self-resolving complications.
3.6 The committee was informed that the procedure may provide more benefit for people with smaller prostates and well-functioning bladders.
3.7 The committee was informed that preservation of sexual function may be a benefit of this procedure.
ISBN: 978-1-4731-4727-0