BMJ Open BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from Effectiveness of continence promotion for older women via community organisations: a cluster randomised trial ForJournal: peerBMJ Open review only Manuscript ID: bmjopen-2013-004135 Article Type: Research Date Submitted by the Author: 27-Sep-2013 Complete List of Authors: Tannenbaum, Cara; Université de Montréal, Faculty of Medicine Agnew, Rona; Glasgow Caledonian University, Benedetti, Andrea; McGill University, Departments of Medicine and of Epidemiology, Biostatistics & Occupational Health Thomas, Doneal; McGill University, Departments of Medicine and of Epidemiology, Biostatistics & Occupational Health van den Heuvel, Eleanor; Brunel University, <b>Primary Subject Urology Heading</b>: Secondary Subject Heading: Geriatric medicine Keywords: Urinary incontinences < UROLOGY, PUBLIC HEALTH, GERIATRIC MEDICINE http://bmjopen.bmj.com/ on September 24, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 35 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 4 5 Effectiveness of continence promotion for older women via community organisations: 6 a cluster randomised trial 7 8 9 1 2 3 10 Cara Tannenbaum, MD, MSc Rona Agnew, PhD Andrea Benedetti, PhD Doneal 11 Thomas, MSc4 Eleanor van den Heuvel, PhD5 12 13 14 1 15 AssociateFor Professor, peer Faculty of Medicine, review Université de Montréal, only Quebec, Canada 16 2Clinical Research Fellow, Glasgow Caledonian University, Glasgow, UK 17 18 3Associate Professor, Departments of Medicine and of Epidemiology, Biostatistics & 19 20 Occupational Health, McGill University, Quebec, Canada 21 4PhD candidate, Department of Epidemiology, Biostatistics & Occupational Health, 22 23 McGill University, Quebec, Canada 24 5 25 Director of Assistive Technology Programme, Brunel Institute for Ageing Studies, 26 Brunel University, Uxbridge, UK 27 28 29 30 Word count : 3182 31 32 33 Key words: Continence promotion, cluster trial, community organisations, older 34 http://bmjopen.bmj.com/ 35 women, urinary incontinence 36 37 38 Corresponding Author: Dr. Cara Tannenbaum, Centre de Recherche de l’Institut 39 40 universitaire de gériatrie de Montréal, 4545 Queen Mary Road, Montreal, Quebec, 41 Canada H3W 1W5. Tel (514) 340-2800. Fax : (514) 340-3530. 42 on September 24, 2021 by guest. Protected copyright. 43 Email: [email protected] 44 45 46 The Corresponding Author has the right to grant on behalf of all authors and does 47 48 grant on behalf of all authors, an exclusive licence on a worldwide basis to the BMJ 49 50 Publishing Group Ltd to permit this article (if accepted) to be published in BMJ Open 51 editions and any other BMJPGL products and sublicences such use and exploit all 52 53 subsidiary rights, as set out in the licence. 54 55 56 57 58 59 60 1 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 35 BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 All authors have completed the Unified Competing Interest form at 4 5 www.icmje.org/coi_disclosure.pdf (available on request from the corresponding 6 author) and declare: no support from any organisation for the submitted work; no 7 8 financial relationships with any organisations that might have an interest in the 9 10 submitted work in the previous three years, and no other relationships or activities that 11 could appear to have influenced the submitted work. 12 13 14 15 The authorsFor retained peerfull independence review from the study sponsors only in the design, 16 implementation, analysis, interpretation and reporting of the findings. 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41 42 on September 24, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 2 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 35 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 ABSTRACT 4 5 6 Objectives: The primary objective of this cluster randomised controlled trial was to 7 8 compare the effectiveness of the three experimental continence promotion 9 10 interventions against a control intervention on urinary symptom improvement in older 11 women with untreated incontinence recruited from community organisations. A 12 13 second objective was to determine whether changes in incontinence-related 14 15 knowledge,For new uptake peer of risk-modifying review behaviours explained only these improvements. 16 17 18 Setting: 71 community organisations across the United Kingdom 19 20 21 Participants: 259 women aged 60 years with untreated incontinence entered the trial; 22 23 88% completed the 3-month follow-up. 24 25 26 Interventions: The three active interventions consisted of a single 60-minute group 27 28 workshop on 1) continence education (20 clusters, 64 women); 2) evidence-based 29 30 self-management (17 clusters, 70 women); or 3) combined education and self- 31 management (17 clusters, 61 women). The control intervention was a single 60- 32 33 minute educational group workshop on memory loss, polypharmacy and osteoporosis 34 http://bmjopen.bmj.com/ 35 (17 clusters, 64 women). 36 37 38 Primary and secondary outcome measures: The primary outcome was self-reported 39 40 improvement in incontinence 3 months post-intervention at the level of the individual. 41 Changes in incontinence-related knowledge and behaviours were also assessed. 42 on September 24, 2021 by guest. Protected copyright. 43 44 45 Results: The highest rate of urinary symptom improvement occurred in the combined 46 intervention group (66% vs 11% of the control group, prevalence difference 55%, 47 48 95% CI 43%-67%, intracluster correlation 0). Thirty percent versus 6% of participants 49 50 reported significant improvement respectively (prevalence difference 23%, 95% CI 51 10%-36%, intracluster correlation 0). The number-needed-to-treat was 2 to achieve 52 53 any improvement in incontinence symptoms, and 5 to attain significant improvement. 54 55 Changes in knowledge and self-reported risk-reduction behaviours paralleled rates of 56 improvement in all intervention arms. 57 58 59 60 3 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 35 BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 Conclusion: Continence education combined with evidence-based self-management 4 5 improves symptoms of incontinence among untreated older women. Community 6 organisations represent an untapped vector for delivering effective continence 7 8 promotion interventions. 9 10 11 Trial registration: ClinicalTrials.gov ID number NCT01239836 12 13 14 15 For peer review only 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41 42 on September 24, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 4 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 5 of 35 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 Article Summary : Strengths and limitations of this study 4 5 6 • First study to provide Level 1 evidence that continence promotion is an 7 8 effective strategy for improving urinary symptoms among untreated 9 10 community-dwelling older women 11 12 13 • Participants were recruited via community organisations with representation 14 15 acrossFor diverse peer socio-economic review strata only 16 17 18 • Rates of knowledge acquisition and behaviour change provide an explanatory 19 20 mechanism for the observed improvements in incontinence in participants 21 22 receiving the education combined with the self-management strategy 23 24 25 • Only self-reported outcomes and crude dichotomous measures of behaviour 26 27 change were collected so results must be interpreted with caution 28 29 30 31 32 33 34 http://bmjopen.bmj.com/ 35 36 37 38 39 40 41 42 on September 24, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 5 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 6 of 35 BMJ Open: first published as 10.1136/bmjopen-2013-004135 on 10 December 2013. Downloaded from 1 2 3 Introduction 4 5 6 Urinary incontinence is more frequent than breast cancer, heart disease or diabetes 7 among older women, but remains a stigmatized and untreated condition despite its 8 9 high prevalence. [1-4] In the United States, Canada, the U.K. and other European 10 11 countries, up to 40% of women aged 65 years and older experience involuntary urine 12 leakage, but little more than 15-30% seek care.[1-4] Even fewer physicians feel 13 14 competent evaluating or treating incontinence.[5-6] Urinary incontinence is associated 15 For peer review only 16 with obesity, cardiovascular disease, diabetes, depression, social isolation, decline in 17 function, falls, nursing home admission, and onerous out-of-pocket expenses.[6-10] 18 19 In many cases incontinence can be improved, and even cured, when evidence-based 20 21 diagnostic and treatment strategies are appropriately applied.[6,11-14] 22 23 24 It is a commonly held misconception that incontinence is a normal part of aging.[15] 25 26 Not-for-profit organisations seek to raise continence awareness worldwide and 27 promote treatment for incontinent individuals.