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TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: Study protocol for a cluster randomised controlled trial

Frost, Jessica; Lane, J. Athene; Cotterill, Nikki; Fader, Mandy; Hackshaw-McGeagh, Lucy; Hashim, Hashim; Macaulay, Margaret; MacNeill, Stephanie; Ridd, Matthew; Noble, Sian; Rees, Jonathan; Ridd, Matthew J.; Robles, Luke; Taylor, Gordon; Taylor, Jodi; Drake, Marcus; Worthington, Jo

Authors

Jessica Frost

J. Athene Lane

N Nikki Cotterill Nikki.Cotterill@uwe.ac.uk
Associate Professor on Long Term Conditions (Continence Care)

Mandy Fader

Lucy Hackshaw-McGeagh

Hashim Hashim

Margaret Macaulay

Stephanie MacNeill

Matthew Ridd

Sian Noble

Jonathan Rees

Matthew J. Ridd

Luke Robles

Gordon Taylor

Jodi Taylor

Marcus Drake

Jo Worthington



Abstract

Background: Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men presenting with LUTS are managed by their general practitioner (GP) in the first instance, with conservative therapies recommended as the initial treatment. However, the provision of conservative therapies in primary care is variable and can be time and resource limited. GPs require practical resources to enhance patient engagement with such interventions. TRIUMPH aims to determine whether a standardised and manualised care intervention delivered in primary care achieves superior symptomatic outcome for LUTS versus usual care.

Methods/design: TRIUMPH is a two-arm, cluster randomised controlled trial (RCT) being conducted in 30 National Health Service (NHS) general practices in England. The TRIUMPH intervention comprises a standardised LUTS advice booklet developed for the trial with patient and healthcare professional (HCP) consultation. The booklet is delivered to patients by nurses/healthcare assistants following assessment of their urinary symptoms. Patients are directed to relevant sections of the booklet, providing the manualised element of the intervention. To encourage adherence, HCPs provide follow-up contacts over 12 weeks. Practices are randomised 1:1 to either deliver the TRIUMPH intervention or a usual care pathway. The patient-reported International Prostate Symptom Score (IPSS) at 12 months post consent is the primary outcome. Secondary outcomes include cost-effectiveness, patient-reported outcomes on LUTS, quality of life, and patient and HCP acceptability and experience of the intervention. Primary analyses will be conducted on an intention-to-treat basis.

Discussion: It is unclear whether conservative therapies for male LUTS are effectively delivered in primary care using current approaches. This can lead to men being inappropriately referred to secondary care or experiencing persistent symptoms. Primary care, therefore, holds the key to effective treatment for these men. The TRIUMPH intervention, through its standardised and manualised approach, has been developed to support GP practices in delivering effective conservative care. This pragmatic, cluster RCT should provide robust evidence in a primary-care setting to inform future guidelines.

Journal Article Type Article
Publication Date Sep 2, 2019
Journal Trials
Print ISSN 1745-6215
Electronic ISSN 1745-6215
Publisher BMC
Peer Reviewed Peer Reviewed
Volume 20
Article Number 546
APA6 Citation Taylor, G., Ridd, M. J., Fader, M., Athene Lane, J., Frost, J., Cotterill, N., …Worthington, J. (2019). TReatIng Urinary symptoms in Men in Primary Healthcare using non-pharmacological and non-surgical interventions (TRIUMPH) compared with usual care: Study protocol for a cluster randomised controlled trial. Trials, 20, https://doi.org/10.1186/s13063-019-3648-1
DOI https://doi.org/10.1186/s13063-019-3648-1
Keywords TRIUMPH, lower urinary tract symptoms, cluster randomised controlled trial, primary care, International Prostate Symptom Score.
Publisher URL https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3648-1

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Copyright Statement
© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided 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 Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.







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