Treatment of lower urinary tract symptoms in men in primary care using a conservative intervention: cluster randomised controlled trial

Abstract

Objective To determine whether a standardised and manualised care intervention in men in primary care could achieve superior improvement of lower urinary tract symptoms (LUTS) compared with usual care. Design Cluster randomised controlled trial. Setting 30 National Health Service general practice sites in England. Participants Sites were randomised 1:1 to the intervention and control arms. 1077 men (≥18 years) with bothersome LUTS recruited between June 2018 and August 2019: 524 were assigned to the intervention arm (n=17 sites) and 553 were assigned to 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 LUTS in men. After assessment of urinary symptoms (manualised element), general practice nurses and healthcare assistants or research nurses directed participants to relevant sections of the manual and provided contact over 12 weeks to assist with adherence. Main outcome measures The primary outcome was patient reported International Prostate Symptom Score (IPSS) measured 12 months after participants had consented to take part in the study. The target reduction of 2.0 points on which the study was powered reflects the minimal clinically important difference where baseline IPSS is <20. Secondary outcomes were patient reported quality of life, urinary symptoms and perception of LUTS, 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 adjusted for site level variables used in the randomisation and baseline scores. Results Participants in the intervention arm had a lower mean IPSS at 12 months (adjusted mean difference −1.81 points, 95% confidence interval −2.66 to −0.95) indicating less severe urinary symptoms than those in the usual care arm. LUTS specific quality of life, incontinence, and perception of LUTS also improved more in the intervention arm than usual care arm at 12 months. The proportion of urology referrals (intervention 7.3%, usual care 7.9%) and adverse events (intervention seven events, usual care eight events) were comparable between the arms. Conclusions A standardised and manualised intervention in primary care showed a sustained reduction in LUTS in men at 12 months. The mean difference of −1.81 points (95% confidence interval −0.95 to −2.66) on the IPSS was less than the predefined target reduction of 2.0 points. Trial registration ISRCTN Registry ISRCTN11669964 .

Cost-effectiveness of a primary healthcare intervention to treat male lower urinary tract symptoms: the TRIUMPH cluster randomised controlled trial

“…The cost-effectiveness analysis of the TRIUMPH study showed that there were similar costs and outcomes between the two arms of the trial, indicating that the provision of a manualised and standardised non-pharmacological intervention in general practice can be implemented at a neutral cost. This evidence in conjunction with the improvement shown in the effectiveness study 5 , gives support to its implementation within primary care services in the UK.…”

“…The present study, TReatIng Urinary symptoms in Men in Primary Healthcare (TRIUMPH), sought to provide evidence on whether the provision of a manualised and standardised non-pharmacological intervention in primary care, is effective and cost-effective compared with usual care. The effectiveness results, reported elsewhere, showed improved symptoms for men with LUTS and these benefits were sustained for a full year 5. The current cost-effectiveness study is conducted from a National Health Service (NHS) perspective over a 12-month time horizon, with the intention to inform clinical practice decisions within primary care.…”

“…The effectiveness results, reported elsewhere, showed improved symptoms for men with LUTS and these benefits were sustained for a full year. 5 The current cost-effectiveness study is conducted from a National Health Service (NHS) perspective over a 12-month time horizon, with the intention to inform clinical practice decisions within primary care. The analysis is reported according to the Consolidated Health Economic Evaluation Reporting Standards guidelines.…”

Evaluation of Lower Urinary Tract Symptoms in Males and Urinary Incontinence in Females in Primary Health Care in Greece

“…LUTS are anticipated to be initially assessed and managed in primary care settings. Nonetheless, the assessment of LUTS and the implementation of conservative measures in primary care are limited and inconsistent [ 26 , 27 ]. Indeed, the level of adherence to recommended standards of care for LUTS among men in primary care seems to be low, particularly among older men who have a higher prevalence of LUTS [ 26 ].…”

“…Consequently, active screening for LUTS in primary care should be considered in order to identify patients exhibiting symptoms that could benefit from treatment, resulting in improvements in quality of life, decreased long-term morbidity, and potential savings in medical resources [ 28 ]. However, it is crucial for primary care physicians to have practical resources that can aid in the assessment of LUTS and improve patient involvement in lifestyle changes and conservative (non-surgical) management interventions [ 27 ]. Symptom questionnaires are standard instruments that can be utilized for assessing male and female LUTS, identifying symptom variations, and continuously monitoring treatment effectiveness [ 29 , 30 ].…”