Treating male lower urinary tract symptoms in primary healthcare using conservative interventions: the TRIUMPH cluster randomised controlled trial

Objective(s): To determine whether a standardised and manualised intervention for Lower Urinary Tract Symptoms (LUTS) achieves superior symptomatic improvement versus usual care. Design: 2-arm cluster randomised controlled trial where sites were randomised 1:1 to the intervention and control arms. Setting: 30 NHS General Practice sites in England with an adequate number of potentially eligible patients. Participants: 1,077 adult men (≥18) with bothersome LUTS recruited between June 2018 and August 2019 (524 in the intervention arm (n=17 sites) and 553 in the usual care arm (n=13 sites)). Intervention: Standardised information booklet, developed with patient and expert input, providing guidance on conservative and lifestyle interventions for male LUTS. Participants were directed to relevant sections by general practice nurses/healthcare assistants or research nurses following urinary symptom assessment (manualised element) with subsequent contacts over 12 weeks to assist adherence. Main outcome measures: Patient-reported International Prostate Symptom Score (IPSS) primary outcome 12 months after participant consent. Secondary patient-reported outcomes of quality of life (QoL), urinary symptoms and LUTS perception, hospital referrals and adverse events. The primary intention-to-treat analysis included 887 participants (82% of those recruited) and used a mixed effects multilevel linear regression model adjusting for site-level variables used in the randomisation and baseline scores. Results: Participants in the intervention arm had a lower mean IPSS score at 12 months (adjusted mean difference of -1.81 points, 95% Confidence Interval (CI) -2.66 to -0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS-specific QoL, incontinence and LUTS perception also improved more in the intervention arm at 12 months. The proportion of urology referrals and numbers of adverse events were comparable between arms. Conclusions: The standardised and manualised intervention in a UK primary care setting showed a sustained reduction in LUTS (difference in mean IPSS of -1.81 at 12 months (95% CI: -0.95 to -2.66)), which was less than the predefined target reduction of 2.0. Trial registration: ISRCTN registry – ISRCTN1166996