Skip to content

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

Research output: Contribution to journalArticle

Original languageEnglish
Article number546 (2019)
Number of pages12
JournalTrials
Volume20
DOIs
DateAccepted/In press - 10 Aug 2019
DatePublished (current) - 2 Sep 2019

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.

Trial registration
ISCRTN registry, ID: ISRCTN11669964. Registered on 12 April 2018.

    Research areas

  • TRIUMPH, Lower urinary tract symptoms, Cluster randomised controlled trial, Primary care, International Prostate Symptom Score

    Structured keywords

  • BRTC
  • Centre for Surgical Research

Download statistics

No data available

Documents

Documents

  • Full-text PDF (final published version)

    Rights statement: This is the final published version of the article (version of record). It first appeared online via Springer Nature at https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3648-1#. Please refer to any applicable terms of use of the publisher.

    Final published version, 1007 KB, PDF document

    Licence: CC BY

  • Supplementary information PDF

    Final published version, 118 KB, PDF document

    Licence: CC BY

DOI

View research connections

Related faculties, schools or groups