Surgical interventions for women with stress urinary incontinence: systematic review and network meta-analysis of randomised controlled trialsBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l1842 (Published 05 June 2019) Cite this as: BMJ 2019;365:l1842
- Mari Imamura, research fellow1,
- Jemma Hudson, statistician1,
- Sheila A Wallace, research fellow2,
- Graeme MacLennan, professor of medical statistics and director3,
- Michal Shimonovich, research assistant1,
- Muhammad Imran Omar, guidelines office methodology supervisor4,
- Mehdi Javanbakht, senior research associate2,
- Eoin Moloney, research associate2,
- Frauke Becker, senior researcher5,
- Laura Ternent, senior lecturer2,
- Isobel Montgomery, patient and public involvement lay representative6,
- Phil Mackie, lead consultant in public health, Scottish Public Health Network/head of Knowledge & Research Services7,
- Lucky Saraswat, consultant gynaecologist8,
- Ash Monga, consultant gynaecologist9,
- Luke Vale, professor of health economics2,
- Dawn Craig, professor of evidence synthesis2,
- Miriam Brazzelli, senior research fellow1
- 1Health Services Research Unit, University of Aberdeen, Aberdeen, UK
- 2Institute of Health & Society, Newcastle University, Newcastle upon Tyne, UK
- 3Centre for Health Care Randomised Trials, Health Services Research Unit, University of Aberdeen, Aberdeen, UK
- 4European Association of Urology, Arnhem, Netherlands
- 5Health Economics Research Centre, University of Oxford, Oxford, UK
- 6Aberdeen, UK
- 7NHS Health Scotland, UK
- 8Aberdeen Royal Infirmary, Aberdeen, UK
- 9University Hospitals Southampton Foundation Trust, Southampton, UK
- Correspondence to: D Craig
- Accepted 8 April 2019
Objectives To compare the effectiveness and safety of surgical interventions for women with stress urinary incontinence.
Design Systematic review and network meta-analysis.
Eligibility criteria for selecting studies Randomised controlled trials evaluating surgical interventions for the treatment of stress urinary incontinence in women.
Methods Identification of relevant randomised controlled trials from Cochrane reviews and the Cochrane Incontinence Specialised Register (searched May 2017), which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Medline In-Process, Medline Epub Ahead of Print, CINAHL, ClinicalTrials.gov, and WHO ICTRP. The reference lists of relevant articles were also searched. Primary outcomes were “cure” and “improvement” at 12 months, analysed by means of network meta-analyses, with results presented as the surface under the cumulative ranking curve (SUCRA). Adverse events were analysed using pairwise meta-analyses. Risk of bias was assessed using the Cochrane risk of bias tool. The quality of evidence for network meta-analysis was assessed using the GRADE approach.
Results 175 randomised controlled trials assessing a total of 21 598 women were included. Most studies had high or unclear risk across all risk of bias domains. Network meta-analyses were based on data from 105 trials that reported cure and 120 trials that reported improvement of incontinence symptoms. Results showed that the interventions with highest cure rates were traditional sling, retropubic midurethral sling (MUS), open colposuspension, and transobturator MUS, with rankings of 89.4%, 89.1%, 76.7%, and 64.1%, respectively. Compared with retropubic MUS, the odds ratio of cure for traditional sling was 1.06 (95% credible interval 0.62 to 1.85), for open colposuspension was 0.85 (0.54 to 1.33), and for transobtrurator MUS was 0.74 (0.59 to 0.92). Women were also more likely to experience an improvement in their incontinence symptoms after receiving retropubic MUS or transobturator MUS compared with other surgical procedures. In particular, compared with retropubic MUS, the odds ratio of improvement for transobturator MUS was 0.76 (95% credible interval 0.59 to 0.98), for traditional sling was 0.69 (0.39 to 1.26), and for open colposuspension was 0.65 (0.41 to 1.02). Quality of evidence was moderate for retropubic MUS versus transobturator MUS and low or very low for retropubic MUS versus the other two interventions. Data on adverse events were available mainly for mesh procedures, indicating a higher rate of repeat surgery and groin pain but a lower rate of suprapubic pain, vascular complications, bladder or urethral perforation, and voiding difficulties after transobturator MUS compared with retropubic MUS. Data on adverse events for non-MUS procedures were sparse and showed wide confidence intervals. Long term data were limited.
Conclusions Retropubic MUS, transobturator MUS, traditional sling, and open colposuspension are more effective than other procedures for stress urinary incontinence in the short to medium term. Data on long term effectiveness and adverse events are, however, limited, especially around the comparative adverse events profiles of MUS and non-MUS procedures. A better understanding of complications after surgery for stress urinary incontinence is imperative.
Systematic review registration PROSPERO CRD42016049339.
Contributors: SW conducted literature searches, selected articles for inclusion, and formatted the references. MI and MS evaluated full text papers with SW, extracted data, and assessed risk of bias. MI, MB, JH, and GML selected results for inclusion and planned the statistical analyses. JH performed all network and pairwise meta-analyses under supervision of GML. MIO and MI graded the quality of evidence. DC and LV provided methodological expertise. AM, LS, and PM provided clinical expertise. IM provided a patient perspective. MJ, EM, FB, and LT contributed to various aspects of the broader National Institute for Health Research (NIHR) Health Technology Assessment (HTA) project on which this manuscript is based. MI, MB, DC, and JH drafted the first version of the manuscript. All authors contributed to the revision of the first draft of the manuscript, critically checked its content, and approved its final version. MB was responsible for the integrity and accuracy of the data and is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.
Funding: This project was funded by the NIHR HTA programme (project No 15/09/06). The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care, UK. The funders were not actively involved in the research process at any stage. The study design; collection, analysis, and interpretation of data; writing of the manuscript; and decision to submit it for publication were performed independent of the funders.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; LV reports grants from the NIHR systematic reviews funding stream outside the submitted work and is a member of funding panel NIHR HTA CET panel until march 2018 and coordinating editor of the Cochrane Incontinence Group; AM was a paid speaker for Astellas, SEP Pharma, Boston Scientific, and Atlantic; no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: Not required.
Data sharing: No additional data available.
Transparency: The manuscript’s guarantor (MB) affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as originally planned (and, if relevant, registered) have been explained.
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