Discussion
LUTS, monosymptomatic nocturia
ADVERSE EVENT, SECONDARY, INCONTINENCE, INCONTINENCE
This large, pragmatic randomised controlled trial in primary care showed that a range of bothersome LUTS improved over 12 months in men with mean IPSS scores regarded as reflecting moderate severity LUTS, using a standardised booklet and manualised approach to symptom management. The mean patient reported primary outcome (IPSS) was 1.81 points lower in the intervention arm than usual care arm. The secondary outcomes measured using the International Consultation on Incontinence Questionnaire and IPSS quality of life also showed improvement against usual care, demonstrating the overall impact on LUTS through incontinence, post-void dribble, and quality of life. In addition, participants’ perception of their LUTS improved over 12 months in the intervention arm (measured using the Brief Illness Perception Questionnaire). Referral rates to urology did not differ greatly between the arms. Adverse events also did not differ greatly between the arms.The response rate of patients invited to participate in the study was 48%, which could be because those men who were historically coded as having LUTS in primary care in the previous five years were no longer experiencing bothersome symptoms, or that inaccuracies were present in the coding. In addition, only a single invitation was sent, with no reminder. Of those who responded, 73% were interested in taking part. Response rates were unrelated to acceptability of the intervention as men were blinded to their randomisation group until they had consented to the study, and without sight of the intervention booklet.The mean IPSS at baseline was 13.6/14.6 in the two randomised groups, which is moderate by the accepted symptom severity categories (scores 8-19). The TRIUMPH study accepted men who were still experiencing any bothersome LUTS despite having consulted their doctor in the previous five years. This included storage or voiding LUTS, post-void dribble, and monosymptomatic nocturia (a symptom that can be caused by a wide range of medical conditions unrelated to the lower urinary tract).The target reduction of 2.0 points on which TRIUMPH was powered was less than the more generally used minimal clinically important difference of 3.0 points for the IPSS,The observed reduction of 1.81 (95% confidence interval −2.66 to −0.95) was smaller than the predefined target reduction of 2.0 points, thus the improvement in symptoms related to the intervention may be small.We did not identify other studies of similar size directed at this issue. A non-randomised pilot study of men with uncomplicated LUTS in secondary care gave access to an online self-management programme in the intervention arm, versus usual care from a urologist.Post-void dribble affects about half of men,A strong focus on drug management of LUTS in men persists,