Editorial comment Re: Surgical management of pelvic organ prolapse in women: A short version Cochrane review

Abstract

Around 1 in 10 women will need a surgical vaginal prolapse repair in their lifetime, and 50% of parous women will have prolapse with symptoms. With our ageing population, this is set to increase. On pages 3 to 12 we publish a precised version of a recently updated Cochrane review on surgery for vaginal prolapse. This shows that despite the prevalence of the problem, and an estimated failure rate for primary surgery of 30%, there is a disappointing lack of evidence about the best surgical techniques. The authors of the Cochrane systematic review, using exhaustive search techniques, found only 22 randomised or quasi-randomised trials on 2368 women undergoing prolapse repair. Most of the trials were small or of poor quality, and addressed disparate operations or types of prolapse, resulting in limited and diffuse evidence. Important take home messages include: abdominal sacrocolpopexy results in a better anatomical outcome than the vaginal sacrospinous colpopexy in women with upper vaginal prolapse, but at higher cost; mesh inlays might improve the objective success rate for anterior repair, but there was no long term evidence of effect on quality of life or failure; and traditional posterior repair is superior to transanal repair for posterior vaginal wall prolapse. In particular, the trials were short on subjective, patient-determined outcomes, which are what matter to women having the surgery. The authors illustrated how limited the current evidence base is for prolapse surgery. This is a particular concern at a time when new procedures, particularly involving mesh or grafts, with or without intro- ducer kits, and laparoscopic approaches, are being promoted without any rigorous evidence about their effectiveness or safety. This raises questions about how well the interests of women are being safeguarded. In particular, the plethora of mesh or graft material, ranging from absorbable (synthetic and biological) to non-absorbable materials, indicates how uncertain we are about the best management. If these were new drugs they would require much more stringent evalua- tion before widespread use. What should we do? One attitude is to just say that there is nothing that can be done, as any research started now will be outdated by the time it is completed. The alternative is to get together as a community, identify the fundamental differ- ences in approaches and to mount collaborative randomised trials to find out which are the most effective, cost-effective and safe. We could also lobby the regulatory authorities to consider introducing safeguards over the introduction of new devices at least until basic safety and efficacy is established. Current impediments at the moment are: lack of stand- ardised, validated outcomes; lack of collaborative clinical networks; a perception that it is not possible to evaluate new surgical procedures (for cost reasons, the long time scale until evidence is available, learning and skill issues, and the introduction of newer procedures before the older ones have been evaluated); and as a result of all these factors, no international track record in mounting such trials.