Title: TReating Urinary symptoms in Men in Primary Healthcare (TRIUMPH) using non-pharmaceutical and non-surgical interventions
Funder: Department of Health and Social Care

Abstract: DESIGN Two-arm cluster RCT randomising GP practices to treat men with lower urinary tract symptoms (LUTS) between a care pathway based on manualised and standardised active management (Intervention arm) and one based on current management (“Usual care” Comparator arm) SETTING GP practices in two centres (Bristol, Southampton). The primary care setting will identify patients at an early stage in the clinical pathway POPULATION Adult men diagnosed as having LUTS by their GP INCLUSION CRITERION Adult men with LUTS which the patient feels are bothersome EXCLUSION CRITERIA Unable to pass urine without a catheter; Relevant neurological disease; Having urological testing for LUTS; Being treated for prostate/ bladder cancer; Previous prostate surgery; Unable to give informed consent/ complete assessments. Poorly-controlled diabetes mellitus HEALTH TECHNOLOGIES The intervention arm assesses type(s) of LUTS present, and gives directed therapy; Advice on liquid intake; Controlling urgency; Exercising the pelvic floor; Emptying the bladder completely; Getting rid of the last drops; Reducing sleep disturbance due to nocturia. PRIMARY OUTCOME Patient reported outcome (IPSS) at 1 year SECONDARY OUTCOMES LUTS/ QoL at 6 & 12 months (ICIQ-UI SF, IPSS); self-management at 6 & 12 months (SAGA); Referrals to GP/ secondary care; Adverse events of treatment; Cost-effectiveness A qualitative study will evaluate patient experiences of intervention and LUTS in the control arm, and clinicians’ views. Semi-structured interviews will be conducted during feasibility, baseline and 3-6 months after the intervention package/ trial inclusion for the control group. Theoretical purposive sampling will be used to cover the population characteristics SAMPLE SIZE To prevent cross-contamination if both arms are run in the same site, we propose cluster randomisation of GP practices, so each practice recruits participants either to the Intervention or the Control arm. The minimum important difference in IPSS scores is 3, but we need to detect a 2 unit difference between arms, as men in the study may be bothered by just one symptom (e.g. nocturia). We estimate 840 patients are needed from 24 practices to detect a difference in IPSS scores of 2 (common standard deviation of 5) with 90% power and significance level 5%. Our estimate has an inflation factor to account for clustering of effects in practices which assumes that practices will be able to recruit 35 patients each and that the intra-class correlation between practices would be 0.05. We allowed for up to 30% of men being lost to follow-up. We will use practice databases to identify potential subjects. Our estimates of eligibility rates, consent and loss-to-follow up are conservative and based on our experience running pragmatic trials PATHWAYS The exact LUTS present differ between individuals, and non-pharmaceutical therapies differ for each LUTS, and this is not reliably addressed in current usual care. The proposed intervention pathway will assess whether manualised selection of relevant therapies by a trained nurse, using a standardised resource covering all LUTS, can tailor treatment to the needs of each patient TIMETABLE Duration 3 years, comprising 6 months set-up/site initiation, 1 year recruitment, 1 year follow-up, 6 months analysis/ dissemination INTERNAL PILOT After 4 months of recruitment, we expect to recruit 120 patients. The threshold below which the trial would be discontinued is 90 patients

Lay abstract: The TRIUMPH (TReating Urinary symptoms in Men in Primary Healthcare) study will test whether personalised advice for individual patients based on a nurse’s assessment of their urinary symptoms improves control of symptoms compared with the usual care offered by GPs. Lower Urinary Tract Symptoms (LUTS) refer to problems with storing urine, such as more frequent passing of urine during the day, having to pass urine overnight or having to rush to the toilet urgently. LUTS also include problems such as slow stream while passing urine, or dribbling afterwards. Half of men over 40 experience at least one LUTS, which can badly impair the lives of the sufferers and their partners. Most men are diagnosed and treated by their GP and usual care is typically giving general advice on lifestyle and offering tablets, such as an “alpha-blocker” for the prostate. However, there are many factors which may not be specifically identified and fully considered, including the potential to avoid tablets by addressing factors such as the patient’s caffeine intake. Detecting these and offering relevant advice is time-consuming, but potentially beneficial to the patient. TRIUMPH is a study of treating men who have bothersome LUTS. It will randomly divide the subjects of the trial into two equal groups. One group will receive “usual care” the other will receive “tailored care”. The results from each group will be compared. Men in the “tailored care” group will be offered non-drug treatment related to their symptoms, based on an assessment by a trained nurse. The nurse will educate the patient on LUTS, teach him the appropriate treatment(s), and provide written information. Ongoing support will be offered to help men adhere to the treatments, which may include advice on drinks, pelvic muscle exercises, bladder training and techniques to reduce dribbling. GP practices in Bristol and Southampton will recruit men to the study, and each practice will provide only one type of LUTS treatment (either usual care, or the tailored care). This is because GPs might alter their usual care if some patients in their practice are receiving tailored care. Men with bothersome LUTS will be invited to participate. They will not be invited (exclusion criteria) if they cannot pass urine without a catheter, have a neurological disease, are being tested for LUTS, are being treated for prostate or bladder cancer, had prostate surgery previously, or cannot provide informed consent. Our main (primary) outcome is to find out if tailored treatment achieves better relief of symptoms overall than usual care, by comparing any changes that occur between the two groups after a year by using a medical questionnaire called the international prostate symptom score (IPSS). We will also compare quality of life, men's belief in their ability to manage LUTS themselves, how many men are referred for extra treatment, adverse effects of the care, and cost-effectiveness. Interviews will be undertaken with a group of men in the study to explore their personal response to the treatment. Those chosen for interview will be selected purposely to represent the population of men attending GP primary care with LUTS. We estimate that we need to recruit 840 men to detect an important difference in symptom score (IPSS scores reduced by 2 points), and we aim to recruit at 24 GP practices. In developing this trial, we consulted our patient advisory group, and a patient is one of the people who will run the study. Our advisory group gave extensive input to the written materials, working with the British Association of Urological Surgeons. The study will take 3 years, including phases to set up the centres, recruit men, follow them up for a year and analyse the results. We will publish the findings in professional journals and public outlets, such as newspapers. We will give a summary of the findings to men who helped with the study

Research activity codes: 6.7 PHYSICAL
Health categories: RENAL AND UROGENITAL