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The Clinical Effects of Neuromodulation Therapies in the Treatment of Faecal Incontinence

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The Clinical Effects of Neuromodulation Therapies in the Treatment of Faecal Incontinence MD(Res) Thesis 2016 THE CLINICAL EFFECTS OF NEUROMODULATION THERAPIES IN THE TREATMENT OF FAECAL INCONTINENCE __________________________________________________________________________________ 1 MD(Res) Thesis 2016 by Noel N. K. S. Thin Queen Mary’s National Centre for Bowel Research and Surgical Innovation A Thesis submitted for the Degree of Medical Doctorate (Research) The University of London November 2016 __________________________________________________________________________________ 2 MD(Res) Thesis 2016 ABSTRACT Background and Aims Sacral nerve stimulation (SNS) is an established therapy for faecal incontinence (FI). Percutaneous tibial nerve stimulation (PTNS) is a newer, less-invasive treatment. The effectiveness, cost and acceptability of these treatments have not been systematically compared. Methods A systematic review of neuromodulation interventions for FI and an investigator-blinded, randomised pilot trial of PTNS vs. SNS including parallel quantitative (clinical outcomes and cost) and qualitative studies. Results The systematic review determined on intention-to-treat, the median success rates for SNS were 63% (range 33-66%), 58% (range 52-81%) and 54% (range 50-58%) in the short, medium and long terms respectively. The success rate for PTNS was 59% at 12 months. In the pilot trial: 40 patients (39 female; mean age 59 years) met eligibility criteria. As designed, 23 were randomised to receive SNS and 17 PTNS. 15 patients progressed to permanent SNS implantation and 16 patients received a full course of PTNS. Within group effect sizes were marginally greater for SNS than PTNS on available case analysis. FI episodes per week at baseline, 3 months and 6 months follow-up: SNS median 5.75 (IQR 5.75-15.5 ) [mean 11.4 (SD 12.0)], 2.5 (2-4.5) [4.0 (4.0)], 1.75 (1.5-5) [4.9 (6.9)], vs. PTNS median 6.5 (IQR 2.5- 16.5) [mean 10.6 (SD 11.2)], 3.5 (0.75-7.25) [5.8 (6.9)], 2.5 (0.75-10.75) [6.3 __________________________________________________________________________________ 3 MD(Res) Thesis 2016 (6.9)]. At least 50% improvement in FI episodes per week at 6 months: SNS 61% vs. PTNS 47%. Effect estimates for SNS with chronic implanted stimulation were larger (67% at 6 months). Clinical FI scores and quality of life improvements complemented these results. Qualitative analysis demonstrated a very high acceptability and safety profile for both treatments. Total costs were £2,906 (SD £122) per patient for PTNS and £12,748 (SD £4,175) for SNS. Conclusions Definitive trial data between SNS or PTNS is lacking. This RCT pilot study determined that in the short-term, SNS confers a small clinical benefit over PTNS for FI but is much more expensive. __________________________________________________________________________________ 4 MD(Res) Thesis 2016 ACKNOWLEDGEMENTS I am forever indebted to my supervisors, Professor Charles H. Knowles, Professor Norman S. Williams and Professor Stephanie J. Taylor for their tireless patience, motivation, encouragement and support throughout my studies, without which completion of this thesis would not have been imaginable. I would also like to personally thank Dr Paul Allen for his support and understanding in ensuring that I am able to complete my studies. I am most grateful for the willingness and enthusiasm with which they have all offered their advice, time and assistance. Further, I should like to pay special tribute to Professor Charles Knowles for providing me with invaluable career guidance, academic advice and personal help in writing this thesis. I am immensely honoured and proud to have been given the opportunity to conduct my studies within the National Centre for Bowel Research and Surgical Innovation within Queen Mary University, London. I have admiration for all those who been part of the incredible work that is being undertaken in that unit. The integration of scientific, pathological, medical and surgical research within the department to combat colorectal disease has been a true revelation. I am grateful to the National Institute of Health Research for providing the funding for these studies (Research for Patient Benefit Grant). I should like to thank my clinical and academic colleagues for their encouragement and camaraderie. Also importantly to all the patients who consented to take part in these studies. Particularly for their compliance and willingness to undertake sometimes prolonged treatment regimens, follow-up and investigations; without which these studies could not be possible. Last but not least I would especially like to thank my wife and family who have been incredibly supportive and understanding, enduring every key stroke of this thesis along with me. __________________________________________________________________________________ 5 MD(Res) Thesis 2016 I should also like to thank the following: Ms Barbara Braithwaite and Ms Debbie Hanson for their administrative support. Ms Sybil Bannister for her assistance as a research nurse. Ms Tatenda Marunda for her assistance as a SNS specialist nurse. Dr Emily Heavy as an independent research assistant conducting the qualitative interviews themselves. Dr Stephen Bremner as a statistician and assisting with the design and conduct of the statistical analysis. Dr Natalia Hounsome as a health economist and assisting with the design and conduct of the health economic analysis. Mr Mike Waring as the database developer and data manager. Dr SM Scott, fellow researchers and all the staff within the GI Physiology Unit at the Royal London Hospital, particularly those involved in the investigation of study patients referred for physiological assessment. Dr Ahsan Alam and Dr Anton Emmanuel within the GI Physiology Unit at University College Hospital, London Mr Gregory Thomas and Miss Caroline Vaizey within the GI Physiology Unit at St. Marks Hospital, London __________________________________________________________________________________ 6 MD(Res) Thesis 2016 To my parents Dr and Mrs Thin, my wife Dr Mei-Ling Thin and daughters Amelie and Nicole __________________________________________________________________________________ 7 MD(Res) Thesis 2016 STATEMENT OF ORIGINALITY All studies within this thesis were undertaken between December 2009 and October 2013. A breakdown of each component (work packages) of the studies and the time taken to undertake each, is further represented in a Gantt chart (Table 2.02, Chapter 2). The author wishes to certify that all the work and opinions presented in this thesis are original in concept, design and execution, although the techniques and methods have been described previously, and are in use in clinical practice. All the interventions, acquisition and analysis of resulting data, as well as the subsequent production of this manuscript were performed by the author unless clearly stated otherwise. In particular the author contributed to the design, conduct and management of every aspect of the study; delivering the timely completion of the trial whilst ensuring patient safety. The author's duties consisted of but were not limited to; securing funding for the project, securing ethical approval, day-to-day administration and conduction of the trial, organisation and chairing of steering group meetings, recruitment of patients and provision of front line clinical care, administration of both treatments, collection of unblinded data, data storage, analysis of data and reporting of data outcomes. Of note the author recruited all patients with the aid of the research nurse (Ms Sybil Bannister) and other clinical research fellows (Mr Ahsan Alam and Mr Gregory Thomas) from other hospitals. The author operated on all patients undertaking SNS intervention himself apart from in four patients, who were from University College London Hospital (London). The author enlisted the help of another research fellow at UCLH (London) but in the majority of cases performed all PTNS interventions himself also. Outcome measure data collection was completed by the research nurse at baseline, 3 months and 6 months to reduce observation bias. Qualitative interviews took roughly an hour to undertake and were conducted by a trained external research assistant (Dr Emily Heavy). The interview audio recordings were transcribed and __________________________________________________________________________________ 8 MD(Res) Thesis 2016 analysed by the author. It is noted that this in itself was a resource intensive process taking an estimated 10-15 hours of work on each interview. The Senior supervisor Professor Taylor supervised the design, conduct and analysis of the qualitative data and gave guidance to the author. To understand qualitative methodology better, the author also undertook a 2 day qualitative data (Interpretative Phenomenological Analysis) course before undertaking any interviews. Support for the study was provided by the Pragmatic Clinical Trials Unit, QMUL (including Prof Taylor, Dr Natalia Hounsome, Dr Stephen Bremner and Dr Emily Heavy). Statistical analysis was blinded and conducted by Senior Statistician, Dr. Stephen Bremner. A descriptive data sheet including medians, interquartile ranges, means and standard deviations were created by the statistician but all figures and tables were produced by the author. Health economic data capture and analysis was guided by the Senior Health Economist, Dr Natalia Housome. Dr Housome and the author together created the data capture tools and analysed the subsequent cost utility of each procedure. Presentation of data was advised by Dr Housome but the mathmatical
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