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 6 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 non-randomised controlled trials and 3 case series 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: time to disease progression, progression-free survival and quality of life.
3.3 The specialist advisers and the committee considered the key safety outcomes to be: infection and bleeding.
3.4 Patient commentary was sought but none was received.
3.5 The committee was informed that the procedure may have a role when treatment with Bacillus Calmette-Guérin (BCG) vaccine is contraindicated or has been unsuccessful, and in patients who are unable to have a cystectomy.
3.6 The committee noted that the authors of the Cochrane review described the studies for this procedure as being poorly reported.