Parts of this chapter are reproduced from Frost et al.1 © The Author(s) 2019. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://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 text below includes minor additions and formatting changes to the original text.
Scientific background and review of current literature
Lower urinary tract symptoms (LUTS) in men substantially affect quality of life, work and other activities; such problematic LUTS are described as ‘bothersome’ according to the impact on the patient.2 LUTS can relate to storage (increased urinary frequency, nocturia, urgency, incontinence), voiding (slow stream, hesitancy, straining) or post-voiding (post-voiding dribble, sensation of incomplete emptying) symptoms.
Men usually present with a range of LUTS. Particularly high-impact LUTS for men are urgency/urgency incontinence, post-micturition dribble, nocturia and increased urinary frequency.3–5 In population-based studies, measures of disease-specific, health-related quality of life are substantially worse among men with higher symptom severity and bother ratings than among men with low symptom severity and bother ratings.6 LUTS can be caused by prostate enlargement, leading to obstruction and/or bladder dysfunction, but are also influenced by men’s lifestyle and habits, such as overall fluid and caffeine intake.
National Institute for Health and Care Excellence (NICE) Clinical Guideline 97 recommends that, on initial presentation with LUTS, men should undergo key assessments to exclude serious medical conditions [malignancy and urinary tract infection (UTI)] and should be asked to complete a bladder diary, to assess the impact of their LUTS and to aid diagnosis.7 Conservative treatment measures (fluid advice, bladder training, urethral compression and release, and pelvic floor muscle exercises) are then recommended as initial interventions.7 On the basis of a systematic review of assessment and therapy of male LUTS, the European Association of Urology (EAU) guidelines on male LUTS for secondary care state that categorising precise symptoms (storage/voiding/post voiding) is an expectation of urological practice, and EAU also recommends conservative treatment measures.8
Proper symptom assessment and explanation of conservative measures are more time-consuming and complex than they may at first appear, owing to differences in individual symptoms and potential causative factors, and the need for conservative care to be tailored. As the average general practitioner (GP) consultation lasts 12 minutes and covers 2.5 problems,9 and given a lack of resources to support the guidelines and conservative approach, the proportion of men receiving the recommended standard of care in primary care is potentially small.
In terms of symptom assessment, a 2016 Royal College of Physicians audit of continence care in primary care showed that < 50% of patients had completed a bladder diary and < 30% had a validated symptom score.10 Thus, men may undergo limited assessment mainly to exclude serious underlying conditions, potentially resulting in treatment for LUTS being sidelined.
The frequency of delivery of conservative treatment measures was also low, with the Royal College of Physicians’ audit demonstrating that < 65% of men had used lifestyle modification, < 50% used behavioural modification and < 35% used bladder training (worse among men aged > 65 years).10 Ineffective delivery of conservative measures in primary care can mean that men simply receive a prescription of medication to treat the prostate, are inappropriately referred to secondary care or endure persistent symptoms.
The evidence to support conservative interventions is also limited. The Cochrane review on lifestyle interventions for the treatment of urinary incontinence in adults11 suggested that there is insufficient evidence to justify fluid advice for treatment of urgency incontinence. However, an NHS evidence update indicated that self-management may have a role in the treatment of LUTS,12 citing a post hoc analysis13 of a single-centre randomised controlled trial (RCT)14 of 140 men with LUTS assigned to standard care plus a self-management programme or standard care alone. Men assigned to the self-management programme reported better voided volumes, and reduced daytime frequency and nocturia. The trial had a relatively small patient population and was conducted in a single tertiary treatment centre. According to NICE Clinical Guideline 97, a multicentre RCT is needed to determine if such results could be replicated in everyday clinical practice.15
Rationale for the trial
The risk of LUTS increases with age, with a prevalence of up to 30% in men aged > 65 years;7 therefore, the number of patients affected is likely to increase as the population ages. As most men with LUTS are managed within primary care, the burden on primary care is likely to grow, and, consequently, so will the need for effective provision of LUTS care.
As only a small proportion of men with LUTS receive the recommended assessments, or recommended standard of conservative care as initial treatment within primary care, there is a clear need for an effective, evidence-based intervention that can be feasibly implemented in routine primary care to support delivery of NICE guidelines. The TRIUMPH (TReatIng Urinary symptoms in Men in Primary Health care using non-pharmacological and non-surgical interventions) trial aimed to address this need within primary care. In addition, with evidence lacking on the effectiveness of self-management programmes for LUTS, the trial aimed to provide the evidence needed to justify this approach and the current guidelines.
The TRIUMPH trial intervention sought to provide detailed conservative care advice for male LUTS. The trial was primarily designed to establish whether or not this approach improved symptomatic outcomes compared with usual care, and whether or not the result was sustained over a longer duration beyond the last follow-up contact with the healthcare professional (HCP). If the TRIUMPH approach proved to be effective, it would provide the necessary resource for general practices to effectively deliver conservative treatment through a pathway led by a practice nurse/healthcare assistant (HCA), reducing GP reconsultation for symptoms, prescribing and unnecessary secondary care referrals.
Trial aims and objectives
The key aim of the TRIUMPH trial was to determine whether or not a standardised and manualised care intervention achieves superior symptomatic outcome, compared with usual care, for male LUTS, with a primary outcome of overall International Prostate Symptom Score (IPSS) measured 12 months after consent, in a primary care setting.
The secondary objectives were to compare the two trial arms with regard to:
- disease-specific quality of life
- symptomatic outcomes
- cost effectiveness
- relative harms
- use of NHS resources
- overall quality of life and general health
- acceptability of assessment and provision of care
- patients’ perception of their LUTS condition.