Critical trial identifies women most likely to benefit from vaginal mesh surgery
A randomized controlled trial led by Dr. Svabik in Prague has shown that pelvic floor imaging can be used to accurately identify women most likely to benefit from vaginal mesh surgery
Read the article: Comparison of vaginal mesh repair with sacrospinous vaginal colpopexy in the management of vaginal vault prolapse after hysterectomy in patients with levator ani avulsion: a randomized controlled trial.
Published online 11 March 2014.
Commentary from author, Dr. K. Svabik
Prague, Czech Republic
"Utilizing ultrasound and imaging in general in urogynecology is still not routine practice. One could compare the situation with the state of perinatology 50 years ago before the introduction of ultrasound when obstetricians would say: “we don’t need ultrasound to deliver babies”. Nowadays, such a viewpoint is almost unimaginable, and there is no doubt that pregnancy outcomes are much better. Perinatology has moved forward due to ultrasound. It has moved from guessing and personal interpretation to knowing and seeing, to prediction on the basis of solid evidence.
"This is exactly what should be happening in urogynecology. We are moving from diagnosis based on clinical skills only to diagnosis through a combination of clinical examination and imaging, towards prediction on the basis of solid evidence, and towards individualisation of therapy. The most important steps is to acknowledge the opportunities provided by imaging and to start using it. Pelvic floor ultrasound is not a complicated technique, and there are many opportunities for teaching and learning.
"We believe that our study is novel and important but, it is still only one stone of a large mosaic.
"Using a noninvasive assessment by pelvic floor ultrasound, we identified patients at high risk of recurrence and used that as entry criterion for our study. This allowed us to demonstrate the benefits of a non-conventional surgical approach in a high- risk group of patients. This reduced risk to patients and saved time and resources. We hope that our results will encourage other centers to use modern diagnostic techniques to optimize study design in surgical intervention trials.This will help provide timely, more accurate and reliable results, at much lower cost. Most importantly, our patients will receive better, faster and more individualized treatment as a result."
Commentary from Dr Hans Peter Dietz
Sydney, Australia
"There is a problem with my chosen subspecialty of Urogynecology. The diagnostic side of the field is rather underdeveloped, to the extent that many common conditions aren’t sought on clinical examination, let alone diagnosed by objective means such as imaging. On the other hand, urogynecologists are very innovative surgeons. We have developed several dozens of new procedures over the last 20 years, some of them highly useful, others questionable. Between 2004 and 2012 a large number of mesh procedures were developed and introduced to prolapse surgery. In retrospect, many thousands of operations were performed on the wrong patients, and some of those patients have suffered serious harm. Since 2006, UOG has published a number of papers and reviews dealing with pre-operative patient selection and with the analysis of mesh complications and failure, but the impact of all this effort has been limited due to a lack of interest from industry and due to the inertia of opinion leaders in our field.
"Svabik et al. are an exception, and they show us how powerful the tools of modern imaging can be when used in the context of a clinical trial. Any new procedure has to be tested in randomised controlled trials. Such trials have to be designed to maximise power and clinical utility, and to minimise risk to patients. A procedure that seems effective in case series needs to be tested in randomised controlled trials, and the first should be undertaken in a high- risk group. This requires a proper diagnostic work-up- in this case with imaging to identify patients with levator avulsion, which has been shown to be the main risk factor for recurrence in multiple studies.
"Svabik et al. based their study design on a well- informed evaluation of the current literature, and the result is there for all to see. While the device tested in this trial, the Anterior Prolift, has been taken from the market due to irregularities with the original FDA approval, alternatives are available to which these results are applicable. Prolapse recurrence is so common in the high- risk patients identified by Svabik et al. that conventional surgery seems pointless, and the increased risk of complications after mesh surgery is easily balanced by the markedly increased cure rate. At the very least such high- risk patients need to be allowed the opportunity to decide for themselves whether they want to risk a 50% higher recurrence rate or a 10% higher rate of complications.
"Unfortunately, the insight exemplified by the Svabik trial is still rather uncommon. Other investigators are spending millions of dollars on studies recruiting thousands of patients using the wrong inclusion criteria, suboptimal interventions and poor outcome measures. The result will be papers in high- impact journals reporting type 2 errors (false- negative findings) due to the dilutional effects of poor study planning. One can only hope that more investigators with the kind of insight displayed by the Prague group will show the folly of such an attitude."