OBJECTIVES A 12 week clinical trial (TIMES) demonstrated that therapy with tolterodine extended release (TOL) + tamsulosin (TAM) provides clinical benefits versus TOL or TAM monotherapy or placebo (PBO) in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB). The present analysis estimated the costs and quality adjusted life years (QALYs) associated with these therapies from the perspective of the UK health care system. METHODS TIMES cohorts receiving TOL, TAM, TOL+TAM, or PBO were followed from therapy initiation to 12 weeks. A decision tree model was used to extrapolate the 12-week results to 1 year (including need for surgery owing to treatment failure at 12 weeks), and to track patients' outcomes (symptoms, utility, and costs). Because TIMES did not include costs and QALYs, data from the EpiLUTS epidemiologic survey (9416 males) were used to model a mathematical relationship between LUTS (daytime and nocturnal frequency, urgency episodes, urgency urinary incontinence episodes, and International Prostate Symptom Scores [IPSS]), quality of life, and utility. This was used to convert improvements in TIMES patients' LUTS into utility scores and QALYs. The model included drug and surgery procedure costs and hospital length of stay. RESULTS Incremental QALYs of TOL+TAM vs PBO, TAM and TOL were 0.033, 0.016 and 0.011, and corresponding incremental costs were £262, £253 and -£30, respectively, resulting in cost-utility ratios for TOL+TAM of £7,894/QALY gained compared with PBO, and £15,346/QALY gained compared with TAM. TOL+TAM combination therapy was both more effective and cost-saving compared with TOL. Univariate sensitivity analyses showed that patient utility was most responsive to changes in IPSS score and number of urgency episodes. Changing the percentage of patients undergoing surgery did not substantially affect model outcomes. CONCLUSIONS The TOL+TAM combination therapy appears to be cost-effective compared with TOL or TAM monotherapy or PBO in male patients with LUTS.