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 14 sources, which was discussed by the committee. The evidence included 1 systematic review, 2 randomised controlled trials (1 of which is also included in the systematic review), 1 non-randomised comparative study, 6 case series (4 of which are also included in the systematic review) and 3 case reports. In addition, there are data from a survey of 535 sites with 113,174 patients. The evidence 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: subjective and objective measures of stress urinary incontinence, and quality of life.
3.3 The professional experts and the committee considered the key safety outcomes to be: vaginal discharge, ulceration, scarring, de novo urge incontinence, and fistula.
3.4 Patient commentary was sought but none was received.
3.5 The committee noted that continuation of pelvic floor exercises is important in the management of stress urinary incontinence.
3.6 The committee was informed that this procedure has been done in a large number of patients and it was disappointed with the level of published evidence on the procedure's long-term efficacy.