Open or laparoscopic colposuspension for stress incontinence: new evidence too late?
Article first published online: 25 AUG 2006
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 113, Issue 9, pages 985–987, September 2006
How to Cite
Tincello, D. (2006), Open or laparoscopic colposuspension for stress incontinence: new evidence too late?. BJOG: An International Journal of Obstetrics & Gynaecology, 113: 985–987. doi: 10.1111/j.1471-0528.2006.01049.x
- Issue published online: 25 AUG 2006
- Article first published online: 25 AUG 2006
- Accepted 10 July 2006.
Retropubic colposuspension has long been recognised as one of the most effective surgical procedures for stress urinary incontinence. In 2005, the Cochrane Collaboration concluded that open colposuspension was ‘an effective treatment modality for stress urinary incontinence especially in the long term’.1
As in many areas of gynaecological surgery, the role of laparoscopic surgery for incontinence has increased in the past 5–10 years. Laparoscopic colposuspension has been evaluated in several studies comparing it with open colposuspension, five of which were deemed of sufficient quality to be included in the Cochrane review on laparoscopic colposuspension published in 2001.2 These trials were all small, recruiting a total of 487 women between them, with mostly only medium-term follow up (18 months). The Cochrane review concluded that laparoscopic colposuspension had the benefit of a more rapid recovery but may have a higher complication rate, be more expensive and possibly less effective in the long term than open colposuspension. The need for further well-designed studies was highlighted. In this issue of BJOG, we have published reports of two randomised controlled trials comparing laparoscopic with open colposuspension, which go some way to addressing this deficiency in the evidence. Carey et al.3 report a randomised trial from Australia which recruited 200 women during 1997 and 1998, with 2-year follow up available for 83% of participants and longer term subjective data from a similar proportion. The primary outcome measure was objective cure (absence of urodynamic stress incontinence) at 6 months, powered to detect a difference of 20% between the two arms. Secondary measures included patient satisfaction, quality of life and general wellbeing, and complications. Kitchener et al.4 report the results of the COLPO trial, funded by the Medical Research Council in the UK, which recruited 291 women between 1999 and 2001, with a 2-year follow-up rate of more than 80%. The primary outcomes were objective (dry pad test) and subjective (symptom report) cure at 24 months. Secondary outcomes included recovery time, complications and a formal cost–benefit analysis. The trial was powered to show noninferiority of laparoscopic colposuspension to open colposuspension, assuming a cure rate of 80% for the open procedure.
Both studies were well designed, well conducted and clearly reported. So what did they find? Carey et al.3 found no difference in urodynamic cure rate, incidence of detrusor overactivity (DOA) or patient satisfaction at 6 months, with an overall objective cure rate of 75%. DOA occurred in 22% of women, so that 66% of women were urodynamically ‘normal’. Subjective satisfaction was much higher (88% overall) in keeping with the results of other studies of surgery for stress incontinence.5 Laparoscopic colposuspension took longer but was associated with less bleeding and a more rapid return to normal activity. Laparoscopic, but not open, surgery was associated with an improvement in the reported physical health scores. The lack of difference in cure persisted at 24 months and beyond, with 66% of women having no stress incontinence.
Kitchener et al.4 also found no difference in the objective cure rate (79% for laparoscopic versus 70% for open) or subjective cure rate (55 versus 54%) between the study arms, again showing the mismatch between objective and subjective assessments already mentioned. The study was slightly underpowered based upon the sample size calculations, but their analyses clearly demonstrated that laparoscopic colposuspension is not inferior to open colposuspension. The complication rate was low in both arms, with more bowel and bladder injuries in the laparoscopic arm and more wound infections in the open arm. Each demonstrated comparable improvements in generic quality-of-life scores. No difference in return to work was identified in this study.
The cost–benefit analysis accompanying this study (and also published in this month’s journal) is illuminating as it shows that a greater quality-adjusted life year total is achieved in the laparoscopic arm at both 6 and 24 months, suggesting that laparoscopic surgery confers additional benefits of wellbeing.6 Furthermore, it shows that the additional costs of laparoscopic surgery were only recouped after 24 months of follow up, thus highlighting the need to address long-term outcomes in any surgical study.
So, these two studies have recruited more women between them than all the studies previously assessed in the published Cochrane review and provided data on longer follow up. We can now be confident that laparoscopic and open colposuspension are equally effective treatments for urodynamic stress incontinence, with equivalent 2-year outcomes. It does appear that laparoscopic surgery has advantages over open surgery in terms of recovery, wellbeing and cost effectiveness.
Of course, during the interval between the start of these two trials and their reporting, there has been a significant move away from colposuspension by any route in favour of the minimally invasive suburethral slings, of which the tension-free vaginal tape (TVT) is the paradigm.7 The initial impetus to this movement was largely on the basis of uncontrolled case series reports and aggressive marketing from industry, although one large well-designed randomised trial by Ward and Hilton5 confirmed the efficacy and safety of the technique. The Cochrane review of open colposuspension examined a total of seven trials comparing TVT with open colposuspension,1 although the trial by Ward and Hilton5 dominated the analysis. The review concluded that TVT and open colposuspension were equally effective but that TVT carried an increased risk of complications, particularly bladder perforation. A cost–benefit analysis based on the Ward and Hilton study showed that TVT was a cost-effective alternative to colposuspension, largely based upon shorter hospital stay and rapid return to work.8 Long-term outcome data from this trial confirm that both TVT and colposuspension retain their efficacy after 2 years.9
What do we know about the comparative efficacy of TVT and laparoscopic colposuspension? There are four studies published comparing these two techniques,10–13 and as one may expect, they differ in numbers of women recruited, outcome measures and length of follow up. Only one study recruited more than 50 women to each arm but used mesh rather than sutures in the laparoscopic arm.13 Two studies demonstrated no difference in subjective cure rate,11,12 while one showed that TVT was superior to laparoscopic colposuspension.13 Objective cure rate appeared similar in all studies, except when mesh was used, where TVT had a higher cure rate.13 Currently, a Cochrane review is in progress and awaited, but it is likely that several questions will remain unanswered until larger studies with consistent outcome measures and long follow up are conducted.
So, given that TVT is a proven effective treatment for stress incontinence which confers rapid return to work and cost savings, some would argue that the two trials published this month are interesting but out of date, as the world has changed. If this is true, should we be interested in the results of new randomised trials comparing open with laparoscopic colposuspension? Has the BJOG done the right thing by publishing these two studies? The answer to these questions must be a resounding ‘yes’. Properly conducted, adequately powered and rigorously designed trials must be published to inform the continuing debate of how best to treat our patients and to uphold the principles of evidence-based medicine. Urogynaecology is particularly susceptible to trends and fashions overtaking robust scientific assessment of surgical procedures, and so a commitment to conduct and complete good quality trials is even more important. Although the lag time from inception to publication may be long, good quality evidence may halt or reverse the rush to follow the latest (industry driven) trends. Even if we have fixed opinions for ourselves, many of our patients are well-informed and wish to make their own decisions after considering all the available evidence. We are beholden to continue to provide the most reliable, comprehensive and up-to-date evidence we can.
The publication of these two trials highlights this tension between the different demands of the scientific community and the biomedical industry. Suburethral slings and artificial meshes for prolapse repair are two areas where the move towards introducing innovative technology has run ahead of the robust clinical evidence that these innovations are safe and effective in the long term. The British Society of Urogynaecology and the British Association of Urological Surgeons have produced guidelines for the introduction of new procedures14 which recommend caution when using new biomaterials and stress the importance of continued audit and clinical vigilance until evidence from robust clinical trials becomes available. This document ties in with the recommendations of the National Institute for Clinical Excellence guidelines on the introduction and monitoring of new interventional procedures. While these measures are to be applauded as worthwhile, perhaps we need to stop and consider if this is entirely the correct approach. Is it time to take control of the debate and encourage our industrial partners to work with us to assess new products within the context of robust clinical trials before they are released onto the market? Should we insist? Is it also time for us to speak out about the enormous disparity in patient data required for a licence for a new drug, compared with that required for a surgical device to obtain a European CE mark? If we do, it will be the patients who benefit in the end.
Conflict of interest
Dr Tincello is an editor of BJOG. He is currently a member of the advisory board to the SUIT study, an observational study assessing cost effectiveness of nonsurgical treatments for stress incontinence, funded by Eli Lilly and Co. and has received honoraria for this work. The honoraria have been managed by the finance office of the University of Leicester to fund aspects of Dr Tincello’s research programme.
- 14Good practice guidelines for urogynaecological and female pelvic reconstructive surgery with particular reference to the introduction of new procedures. 2006 [www.rcog.org.uk/resources/Public/pdf/practice_guidelines_june06.pdf]. Accessed 21 June 2006., .