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 3 systematic reviews, 6 randomised controlled trials, 1 non-randomised comparative study and 3 case series. 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: improvement in symptoms of dryness or atrophy, dyspareunia, itching or burning, measures of vaginal health and sexual functioning, and patient satisfaction.
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 Two commentaries from patients who have had this procedure were discussed by the committee.
3.5 There was a lack of high-quality comparative studies with sufficient numbers of patients and long-term follow up to make a definitive evaluation on the long-term safety and efficacy of this procedure. Urogenital atrophy is a common condition. These considerations underpinned the committee's request for more data collection.
3.6 The committee was informed that the procedure may have a role for patients who are unable to use topical oestrogen.
3.7 The committee was informed that patients may need repeated courses of treatment at regular intervals.