Where to for pelvic organ prolapse treatment after the FDA pronouncements? Reply to Pelikan

Abstract

Dear Editor, We thank Dr. Pelikan [1] for his interest and comments regarding our review article on the treatment of pelvic organ prolapse (POP) after the US Food and Drug Administration (FDA) pronouncements [2]. The author rightly observes that the study by Maher et al. [3] does not support the statement that abdominal sacral colpopexy (ASC) is more effective than vaginal sacrospinous colpopexy (VSC). Indeed, in their randomized controlled trial (RCT) study comparing ASC and VSC, they conclude that both procedures are highly effective for treating vaginal vault prolapse. There were no differences in subjective and objective success rates between the two groups after 2 years follow-up. The International Consultation on Incontinence (ICI) committee reviewed surgery for POP [4] and identified three RCTs designed to compare vaginal and abdominal routes for surgical correction, including Maher et al.’s study [3]. The results are summarized in a Cochrane review byMaher et al. [5] in which they state that these trials provide level I evidence that the overall outcome (including quality of life) is similar between abdominal and vaginal approaches but that sacrospinousbased vaginal procedures have higher anterior and apical anatomical and dyspareunia recurrence rates than ASC. This is somewhat offset by the higher short-term morbidity of open abdominal sacrocolpopexy [4]. Therefore we should have referred to reference 10 instead of reference 14 in our manuscript to support the statement of higher apical success of ASC. A recently published study by Nygaard et al. on the longterm (7 years) outcomes following ASC for POP, with or without Burch urethropexy, reported increasing failure rates after 7 years, which emphazises the need for RCTs with longterm follow-up [6].