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

To estimate the cost-effectiveness of a primary care intervention for male lower urinary tract symptoms (LUTS) compared with usual care. Economic evaluation alongside a cluster randomised controlled trial from a UK National Health Service (NHS) perspective with a 12-month time horizon. Thirty NHS general practice sites in England. 1077 men aged 18 or older identified in primary care with bothersome LUTS. A standardised and manualised intervention for the treatment of bothersome LUTS was compared with usual care. The intervention group (n=524) received a standardised information booklet with guidance on conservative treatment for LUTS, urinary symptom assessment and follow-up contacts for 12 weeks. The usual care group (n=553) followed local guidelines between general practice sites. Resource use was obtained from electronic health records, trial staff and participants, and valued using UK reference costs. Quality-adjusted life-years (QALYs) were calculated from the EQ-5D-5L questionnaire. Adjusted mean differences in costs and QALYs and incremental net monetary benefit were estimated. 866 of 1077 (80.4%) participants had complete data and were included in the base-case analysis. Over the 12-month follow-up period, intervention and usual care arms had similar mean adjusted costs and QALYs. Mean differences were lower in the intervention arm for adjusted costs -£29.99 (95% CI -£109.84 to £22.63) while higher in the intervention arm for adjusted QALYs 0.001 (95% CI -0.011 to 0.014). The incremental net monetary benefit statistic was £48.01 (95% CI -£225.83 to £321.85) at the National Institute for Health and Care Excellence UK threshold of £20 000 per QALY. The cost-effectiveness acceptability curve showed a 63% probability of the intervention arm being cost-effective at this threshold. Costs and QALYs were similar between the two arms at 12 months follow-up. This indicates that the intervention can be implemented in general practice at neutral cost. ISRCTN11669964.

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Competing interests: Prof Marcus Drake reports personal fees from Astellas and Pfizer, outside the submitted work. Dr Jonathan Rees is chair of the Primary Care Urology Society which has received non-promotional sponsorship for annual meetings from Ferring, Astellas, Neotract and IMedicare. He has also received speaker fees from Astellas Pharmaceuticals. Prof Hashim Hashim reports personal fees from Medtronic, Astellas, Allergan and Boston Scientific, outside the submitted work. Prof Athene Lane reports receiving funding for the clinical trials unit (CTU) of which she was co-director, and is currently an active member on the NIHR CTU Standing Advisory Committee. Dr Matthew Ridd has been on several NIHR committees including the Systematic Reviews NIHR Cochrane Incentive Awards, HTA General Committee, Evidence Synthesis Programme Grants Committee, NIHR Incentive Awards Committee and is currently on the Evidence Synthesis Programme Advisory Group. Stephanie MacNeill is an active member of the HTA General Committee.