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Sacral Nerve Stimulation for Urinary Indications Sacral nerve stimulation for urinary indications November 2008 MSAC application 1115 Assessment report © Commonwealth of Australia 2008 ISBN 1-74186-790-8 ISBN 1-74186-791-6 ISSN 1443-7120 ISSN 1443-7139 First printed Paper-based publications © Commonwealth of Australia 2008 This work is copyright. Apart from any use as permitted under the Copyright Act 1968, no part may be reproduced by any process without prior written permission from the Commonwealth. Requests and inquiries concerning reproduction and rights should be addressed to the Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca Internet sites © Commonwealth of Australia 2008 This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran Offices, National Circuit, Barton ACT 2600 or posted at http://www.ag.gov.au/cca Electronic copies of the report can be obtained from the Medical Service Advisory Committee’s Internet site at http://www.msac.gov.au/ Printed copies of the report can be obtained from: The Secretary Medical Services Advisory Committee Department of Health and Ageing Mail Drop 106 GPO Box 9848 Canberra ACT 2601 Enquiries about the content of the report should be directed to the above address. The Medical Services Advisory Committee (MSAC) is an independent committee which has been established to provide advice to the Minister for Health and Ageing on the strength of evidence available on new and existing medical technologies and procedures in terms of their safety, effectiveness and cost- effectiveness. This advice will help to inform government decisions about which medical services should attract funding under Medicare. MSAC recommendations do not necessarily reflect the views of all individuals who participated in the MSAC evaluation. This report was prepared on behalf of the Medical Services Advisory Committee by Ms Amber Watt and, Dr Alun Cameron from the Australian Safety and Efficacy Register of New Interventional Procedures – Surgery (ASERNIP-S) and Mr Richard Norman from the Centre for Health Economics Research Evaluation (CHERE). The report was edited by ASERNIP-S. Minister for Health and Ageing noted MSAC’s advice on Publication approval number: P3-4763 Contents Executive summary ............................................................................................................ vi Introduction..........................................................................................................................1 Background ......................................................................................................................... 2 Sacral nerve stimulation for urinary indications.......................................................... 2 Urinary indications.................................................................................................... 2 Sacral nerve stimulation ........................................................................................... 3 Intended purpose...................................................................................................... 4 Clinical need/burden of disease .................................................................................... 5 Existing procedures......................................................................................................... 6 Comparator..................................................................................................................... 10 Marketing status of the technology............................................................................. 10 Current reimbursement arrangement ......................................................................... 10 Approach to assessment .....................................................................................................12 Search strategy................................................................................................................ 12 Inclusion criteria ............................................................................................................ 13 Review of literature ....................................................................................................... 14 Literature databases ................................................................................................ 14 Data extraction........................................................................................................ 14 Description and methodological quality of included studies............................ 14 Data analysis................................................................................................................... 15 Meta-analysis............................................................................................................ 15 Handling of non-randomised data ....................................................................... 15 Included studies ............................................................................................................. 16 Current and recent clinical trials and health technology assessments of the use of SNS for urinary indications .............................................................................. 16 Expert advice.................................................................................................................. 16 Results of assessment.........................................................................................................17 Descriptive characteristics of included studies.......................................................... 17 Systematic reviews ......................................................................................................... 18 Critical appraisal of comparative studies.................................................................... 19 Critical appraisal of case series..................................................................................... 23 Is it safe?.......................................................................................................................... 24 Adverse events by indication ................................................................................ 24 Adverse events by lead type .................................................................................. 28 Other safety considerations................................................................................... 31 Summary of safety outcomes ................................................................................ 32 Is it effective? ................................................................................................................. 33 Detrusor overactivity.............................................................................................. 33 Urinary retention..................................................................................................... 39 Sacral nerve stimulation for urinary indications i Painful bladder syndrome...................................................................................... 43 Summary of effectiveness outcomes.................................................................... 44 What are the economic considerations?..................................................................... 45 Published evidence on the cost-effectiveness of SNS....................................... 45 Rationale for the cost-effectiveness analysis....................................................... 46 Assumptions............................................................................................................ 46 Structure of the economic evaluation.................................................................. 47 Estimates of costs................................................................................................... 48 Clinical outcomes for use in the economic evaluation...................................... 51 Sensitivity analysis................................................................................................... 53 Financial implications............................................................................................. 53 What are the other considerations?............................................................................. 54 Discussion ......................................................................................................................... 58 Conclusions ....................................................................................................................... 60 Advice ................................................................................................................................ 63 Appendix A MSAC terms of reference and membership ......................................... 64 Appendix B Advisory panel....................................................................................... 66 Appendix C Approach to assessment ....................................................................... 67 Appendix D Studies excluded from the review........................................................
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