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      Complications following vaginal mesh procedures for stress urinary incontinence: an 8 year study of 92,246 women

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          Abstract

          Complications of surgical mesh procedures have led to legal cases against manufacturers worldwide and to national inquiries about their safety. The aim of this study was to investigate the rate of adverse events of these procedures for stress urinary incontinence in England over 8 years. This was a retrospective cohort study of first-time tension-free vaginal tape (TVT), trans-obturator tape (TOT) or suprapubic sling (SS) surgical mesh procedures between April 2007 and March 2015. Cases were identified from the Hospital Episode Statistics database. Outcomes included number and type of procedures, including those potentially confounded by concomitant procedures, and frequency, nature and timing of complications. 92,246 first-time surgical mesh procedures (56,648 TVT, 34,704 TOT, 834 SS and 60 combinations) were identified, including 68,002 unconfounded procedures. Peri-procedural and 30-day complication rates in the unconfounded cohort were 2.4 [2.3–2.5]% and 1.7 [1.6–1.8]% respectively; 5.9 [5.7–6.1]% were readmitted at least once within 5 years for further mesh intervention or symptoms of complications, the highest risk being within the first 2 years. Complication rates were higher in the potentially confounded cohort. The complication rate within 5 years of the mesh procedure was 9.8 [9.6:10.0]% This evidence can inform future decision-making on this procedure.

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          Urinary incontinence in women.

          Urinary incontinence is common in women, but is under-reported and under-treated. Urine storage and emptying is a complex coordination between the bladder and urethra, and disturbances in the system due to childbirth, aging, or other medical conditions can lead to urinary incontinence. The two main types of incontinence in women, stress urinary incontinence and urge urinary incontinence, can be evaluated by history and simple clinical assessment available to most primary care physicians. There is a wide range of therapeutic options, but the recent proliferation of new drug treatments and surgical devices for urinary incontinence have had mixed results; direct-to-consumer advertising has increased public awareness of the problem of urinary incontinence, but many new products are being introduced without long-term assessment of their safety and efficacy.
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            Updated systematic review and meta-analysis of the comparative data on colposuspensions, pubovaginal slings, and midurethral tapes in the surgical treatment of female stress urinary incontinence.

            Burch colposuspension, pubovaginal sling, and midurethral retropubic tape (RT) and transobturator tape (TOT) have been the most popular surgical treatments for female stress urinary incontinence (SUI). Several randomized controlled trials (RCTs) have been published comparing the different techniques, with conflicting results. Our aim was to evaluate the efficacy, complication, and reoperation rates of midurethral tapes compared with other surgical treatments for female SUI. A systematic review of the literature was performed using the Medline, Embase, Scopus, Web of Science databases, and Cochrane Database of Systematic Reviews. Thirty-nine RCTs were identified. Patients receiving midurethral tapes had significantly higher overall (odds ratio [OR]: 0.61; confidence interval [CI]: 0.46-0.82; p=0.00009) and objective (OR: 0.38; CI: 0.25-0.57; p<0.0001) cure rates than those receiving Burch colposuspension, although they had a higher risk of bladder perforations (OR: 4.94; CI: 2.09-11.68; p=0.00003). Patients undergoing midurethral tapes and pubovaginal slings had similar cure rates, although the latter were slightly more likely to experience storage lower urinary tract symptoms (LUTS) (OR: 0.31; CI: 0.10-0.94; p=0.04) and had a higher reoperation rate (OR: 0.31; CI: 0.12-0.82; p=0.02). Patients treated with RT had slightly higher objective cure rates (OR: 0.8;CI: 0.65-0.99; p=0.04) than those treated with TOT; however, subjective cure rates were similar, and patients treated with TOT had a much lower risk of bladder and vaginal perforations (OR: 2.5; CI: 1.75-3.57; p<0.00001), hematoma (OR: 2.62; CI: 1.35-5.08; p=0.005), and storage LUTS (OR: 1.35; CI: 1.05-1.72; p=0.02). Meta-analysis demonstrated similar outcomes for TVT-O (University of Liège, Liège, Wallonia, Belgium) and Monarc (AMS, Minnetonka, MN, USA). Patients treated with RT experienced slightly higher continence rates than those treated with Burch colposuspension, but they faced a much higher risk of intraoperative complications. RT and pubovaginal slings were similarly effective, although patients with pubovaginal slings were more likely to experience storage LUTS. The use of RT was followed by objective cure rates slightly higher than TOT, but subjective cure rates were similar. TOT had a lower risk of bladder and vaginal perforations and storage LUTS than RT. The strength of these findings is limited by the heterogeneity of the outcome measures and the short length of follow-up. Copyright (c) 2010 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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              Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications.

              Various types of suburethral tapes inserted via the transobturator route (tension-free vaginal tape obturator route [TVTO] and transobturator tape [TOT]) have been widely adopted for treatment of stress urinary incontinence (SUI) before proper evaluation of their effectiveness and complications. To assess the effectiveness and complications of TOTs as treatment of SUI by means of a systematic review. MEDLINE, EMBASE, CINAHL, LILIACS (up to September 2006), CENTRAL (The Cochrane Library, Issue 3, 2006), MetaRegister of Controlled Trials, The National Library for Health, the National Research Register and Google Scholar were searched using various relevant search terms. The citation lists of review articles and included trials were searched, and contact with the corresponding author of each included trials was attempted. Randomised controlled trials (RCTs) that compared the effectiveness of TVTO or TOT with synthetic tension-free vaginal tape (TVT) by retropubic route (Gynecare; Ethicon Inc., NJ, USA) for the treatment of SUI in all languages were included. Two reviewers extracted data on participants' characteristics, study quality, population, intervention, cure and adverse effects independently. The data were analysed in the Review Manager 4.2.8 software. There were five RCTs that compared TVTO with TVT and six RCTs that compared TOT with TVT. When compared by subjective cure, TVTO and TOT at 2-12 months were no better than TVT (OR 0.85; 95% CI 0.60-1.21). Adverse events such as bladder injuries (OR 0.12; 95% CI 0.05-0.33) and voiding difficulties (OR 0.55; 95% CI 0.31-0.98) were less common, whereas groin/thigh pain (OR 8.28; 95% CI 2.7-25.4), vaginal injuries or erosion of mesh (OR 1.96; 95% CI 0.87-4.39) were more common after tape insertion by the transobturator route. The evidence for short-term superiority of effectiveness of TOTs is currently limited. Bladder injuries and voiding difficulties are lower, but the risk of vaginal erosions and groin pain is higher with TVTO/TOT. Methodologically sound and sufficiently powered RCTs with long-term follow up are needed, and the results of continuing trials are awaited.
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                Author and article information

                Contributors
                andrew.sims@nuth.nhs.uk
                Journal
                Sci Rep
                Sci Rep
                Scientific Reports
                Nature Publishing Group UK (London )
                2045-2322
                20 September 2017
                20 September 2017
                2017
                : 7
                : 12015
                Affiliations
                [1 ]ISNI 0000 0004 0444 2244, GRID grid.420004.2, Newcastle upon Tyne Hospitals NHS Foundation Trust, ; Newcastle upon Tyne, UK
                [2 ]ISNI 0000 0001 0462 7212, GRID grid.1006.7, Institute of Cellular Medicine, Faculty of Medical Sciences, University of Newcastle upon Tyne, ; Newcastle upon Tyne, UK
                [3 ]ISNI 0000 0000 8937 2257, GRID grid.52996.31, University College London Hospitals NHS Foundation Trust, ; London, UK
                [4 ]GRID grid.430506.4, University Hospital of Southampton NHS Foundation Trust, ; Southampton, UK
                [5 ]ISNI 0000 0004 1794 1878, GRID grid.416710.5, National Institute for Health and Care Excellence, ; London, UK
                [6 ]ISNI 0000 0004 1936 8948, GRID grid.4991.5, Nuffield Department of Primary Care Health Sciences, University of Oxford, ; Oxford, UK
                [7 ]ISNI 0000 0004 1936 8024, GRID grid.8391.3, University of Exeter Medical School, University of Exeter, ; Exeter, UK
                Author information
                http://orcid.org/0000-0002-9553-7278
                Article
                11821
                10.1038/s41598-017-11821-w
                5607307
                28931856
                6a07902b-3a5e-49dd-8c54-f533595e76f6
                © The Author(s) 2017

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 2 June 2017
                : 30 August 2017
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