Systematic review of the efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse Xueli Jia, Cathryn Glazener, Graham Mowatt, Graeme MacLennan, Cynthia Fraser, Jennifer Burr October 2007 INTERVENTIONAL PROCEDURES PROGRAMME NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE REVIEW BODY REPORT Title Systematic review of the efficacy and safety of using mesh or grafts in surgery for anterior and/or posterior vaginal wall prolapse Produced by Health Services Research Unit University of Aberdeen 3rd Floor, Health Sciences Building Foresterhill Aberdeen AB25 2ZD Authors Xueli Jia, Cathryn Glazener, Graham Mowatt, Graeme MacLennan, Cynthia Fraser, Jennifer Burr Correspondence to Xueli Jia Research Fellow Health Services Research Unit University of Aberdeen 3rd Floor, Health Sciences Building Foresterhill AB25 2ZD Tel: (01224) 559801 Fax: (01224) 554580 Email: [email protected] Date completed October 2007 ‘Home unit’ details The Health Services Research Unit (HSRU) is a multidisciplinary research group of about 50 people based in the University of Aberdeen. The Unit is core-funded by the Chief Scientist Office of the Scottish Government Health Directorates, and has responsibility for the following general remit: 1. To study or evaluate clinical activities with a view to improving effectiveness and efficiency in health care; 2. To work for the implementation of proven changes in clinical activities; 3. To encourage and support similar work thoughout Scotland; 4. To train NHS staff in Scotland, and others, in the principles and practice of health services research in general, and health care evaluation in particular. The Unit has an established portfolio of health services research focusing on two main programmes – health care assessment and delivery of care. The Unit is one of the two research groups that make up the ‘Review Body’ for the National Institute for Health and Clinical Excellence Interventional Procedures Programme. The other is based at Health Services Research, University of Sheffield. Contributions of authors Xueli Jia screened the search results, contacted manufactures, assessed studies for inclusion, undertook data abstraction and quality assessment, conducted meta-analysis, and drafted the review. Cathryn Glazener drafted the scope, determined outcome categories, provided advice on assessing studies for inclusion, conducting meta-analysis, and on drafting of the review, drafted the discussion part, and commented on drafts of the review. Graham Mowatt commented on the scope of the review, drafted letters for contacting mesh/graft manufacturers for additional information, supervised the conduct of the review, and commented on drafts of the review. Graeme MacLennan conducted the statistical analysis, drafted the data analysis section of the review, and commented on drafts of the review. Cynthia Fraser developed and ran the literature search strategies, obtained papers, formatted the references, and drafted sections concerning search strategies and search results. Jennifer Burr supervised the conduct of the review, and commented on drafts of the review. ii Conflict of interest Cathryn Glazener was an author on one conference abstract that was included in the review. Acknowledgements We thank Chris Bain (Consultant Obstetrician and Gynaecologist, Aberdeen Royal Infirmary) for providing specialist advice and commenting on the draft of the report. The Health Services Research Unit receives a core grant from the Scottish Government Health Directorates. The views expressed are those of the authors and not necessarily those of the funding bodies. Special thanks also go to James Browning (Mpathy Medical Devices Ltd.), Christine Clarke (Bard Ltd.), Hazel Edwards (American Medical Systems (UK), Ltd.), Adrian Griffin (Johnson & Johnson Medical Ltd.), William Hynes (WL Gore & Associations (UK) Ltd.), and Coloplast Ltd. for providing properties of mesh/graft produced by the manufacturers and published studies relating to mesh/graft. We also thank Paul Moran for providing additional information for a study identified from the National Research Register database. iii TABLE OF CONTENTS Executive summary xi List of abbreviations xxiv 1 OBJECTIVE OF THE REVIEW 1 2 BACKGROUND 2 2.1 Description of the underlying health problem 2 2.1.1 Epidemiology 2 2.1.2 Burden of disease 2 2.1.3 Aetiology, pathology and prognosis 3 2.2 Current management and alternative procedures 3 2.3 The interventional procedure under review 4 2.3.1 Description of the interventional procedure 4 2.3.2 Suitable candidates and relevant subgroups 7 2.3.3 Proposed clinical indications/contraindications and putative impact of the 7 procedure 2.3.4 Personnel involved and skill/experience required 8 2.3.5 Current use in the UK 8 2.3.6 Equipment or devices required 9 3 METHODS FOR REVIEWING SAFETY AND EFFICACY 10 3.1 Search strategy 10 3.2 Inclusion and exclusion criteria 11 3.2.1 Types of studies 11 3.2.2 Types of participants 11 3.2.3 Types of interventions 12 3.2.4 Types of outcomes 12 3.3 Quality assessment strategy 14 3.4 Data extraction strategy 14 3.5 Data analysis 14 4 RESULTS 17 4.1 Number and type of included studies 17 4.1.1 Included studies 18 4.1.2 Ongoing studies 22 iv 4.2 Number and type of excluded studies; reason for exclusion 24 4.3 Quality of available evidence 24 4.4 Anterior repair 26 4.4.1 Efficacy 26 4.4.1.1 Subjective failure: persistent prolapse symptoms 29 4.4.1.2 Objective failure: recurrent prolapse at original site 30 4.4.1.3 De novo prolapse (i.e. new prolapse at other sites) 34 4.4.1.4 Need for further surgery for prolapse 35 4.4.1.5 Persistent urinary incontinence 36 4.4.1.6 Persistent bowel symptoms 36 4.4.1.7 Persistent dyspareunia 36 4.4.1.8 Improvement of disease-specific quality of life (RCTs and non-randomised 36 comparative studies only 4.4.2 Safety 37 4.4.2.1 Blood loss 40 4.4.2.2 Damage to surrounding organs during operation 41 4.4.2.3 Mesh/graft erosion 41 4.4.2.4 Further operation needed for mesh/graft erosion 42 4.4.2.5 De novo urinary incontinence 43 4.4.2.6 De novo bowel symptoms 43 4.4.2.7 De novo dyspareunia 44 4.4.2.8 Infection 44 4.4.2.9 Other serious adverse effects 44 4.4.3 Other outcomes (operation time and surgeon experience) 45 4.4.3.1 Operation time 45 4.4.3.2 Surgeon experience 45 4.4.4 Conclusions of the evidence for and against the use of mesh/graft in anterior 46 vaginal wall prolapse repair 4.5 Posterior repair 49 4.5.1 Efficacy 49 4.5.1.1 Subjective failure: persistent prolapse symptoms 52 4.5.1.2 Objective failure: recurrent prolapse at original site 52 4.5.1.3 De novo prolapse (i.e. at other sites) 54 4.5.1.4 Need for further surgery for prolapse 54 4.5.1.5 Persistent urinary incontinence 54 4.5.1.6 Persistent bowel symptoms 54 4.5.1.7 Persistent dyspareunia 54 v 4.5.1.8 Improvement of disease-specific quality of life (RCTs and non-randomised 55 comparative studies only) 4.5.2 Safety 55 4.5.2.1 Blood loss 58 4.5.2.2 Damage to surrounding organs during operation 58 4.5.2.3 Mesh/graft erosion 59 4.5.2.4 Further operation needed for mesh/graft erosion 59 4.5.2.5 De novo urinary incontinence 59 4.5.2.6 De novo bowel symptoms 59 4.5.2.7 De novo dyspareunia 60 4.5.2.8 Infection 60 4.5.2.9 Other serious adverse effects 60 4.5.3 Other outcomes (operation time and surgeon experience) 61 4.5.3.1 Operation time 61 4.5.3.2 Surgeon experience 61 4.5.4 Conclusions of the evidence for and against the use of mesh/graft in posterior 61 vaginal wall prolapse repair 4.6 Anterior and/or posterior repair 64 4.6.1 Efficacy 64 4.6.1.1 Subjective failure: persistent prolapse symptoms 66 4.6.1.2 Objective failure: recurrent prolapse at original site 66 4.6.1.3 De novo prolapse (i.e. at other sites) 68 4.6.1.4 Further operation needed for prolapse 68 4.6.1.5 Persistent urinary incontinence 68 4.6.1.6 Persistent bowel symptoms 68 4.6.1.7 Persistent dyspareunia 68 4.6.1.8 Improvement of disease-specific quality of life (RCTs and non-randomised 69 comparative studies only) 4.6.2 Safety 69 4.6.2.1 Blood loss 72 4.6.2.2 Damage to surrounding organs during operation 72 4.6.2.3 Mesh/graft erosion 72 4.6.2.4 Further operation needed for mesh/graft erosion 73 4.6.2.5 De novo urinary incontinence 74 4.6.2.6 De novo bowel symptoms 74 4.6.2.7 De novo dyspareunia 74 4.6.2.8 Infection 74 vi 4.6.2.9 Other serious adverse effects 75 4.6.3 Other outcomes (operation time and surgeon experience) 75 4.6.3.1 Operation time 75 4.6.3.2 Surgeon experience 75 4.6.4 Conclusions of the evidence for and against the use of mesh/graft in anterior 75 and/or posterior vaginal wall prolapse repair 5 DISCUSSION 78 5.1 Discussion of main results 78 5.1.1 Anterior vaginal wall prolapse repair 78 5.1.2 Posterior vaginal wall prolapse repair 79 5.1.3 Anterior and/or posterior vaginal wall prolapse repair 80 5.1.4 Generis issues related to mesh 81 5.2 Assumptions, limitations, and uncertainties 82 6 CONCLUSIONS 85 6.1 Implications for the NHS 85 6.2 Implications for further research 86 7 REFERENCE LIST 88 vii LIST OF APPENDICES Appendix 1 Search strategies 96 Appendix 2 Checklist of quality assessment of randomised controlled trials 102 Appendix 3 Checklist of quality assessment of non-randomised studies 103 Appendix 4 Reference list of included studies 104 Appendix 5 Characteristics of the included studies by study design 110 Appendix 6 Summary of properties of mesh/graft used by included studies 152 Appendix 7 Summary of operation techniques used by included studies 158 Appendix 8 Number and type of excluded studies;