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 12 sources, which was discussed by the committee. The evidence included 10 case series, 1 non-randomised comparative study of 2 devices, and 1 case report. It is presented in table 2 of 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: reduced incontinence in the short and long term, improved quality of life, and reduced need for later invasive procedures.
3.3 The professional experts and the committee considered the key safety outcomes to be: infection, bleeding, pain, and device extrusion or migration.
3.4 Patient commentary was sought but none was received.