Comparison of alfuzosin 10 mg with or without propiverine 10 mg, 20 mg in men with lower urinary tract symptom and an overactive bladder: randomised, single-blind, prospective study

Abstract

PurposeThe efficacy and safety of treatment with alfuzosin 10mg plus propiverine 10 or 20mg in men with lower urinary tract symptoms (LUTS) and an overactive bladder were investigated. Materials and methodsIn this parallel-arm, prospective, multicentre, single-blind study, men who were 40years old, had an International Prostate Symptom Score (IPSS) of 8, an Overactive Bladder Symptom Score (OABSS) of 3 and an OABSS urgency item score of 2 were randomised in a 1:1:1 ratio to receive alfuzosin 10mg alone (Group A) or with propiverine 10mg (Group B) or 20mg (Group C) for 8weeks. Four and 8 weeks after commencing treatment, OABSS was measured along with IPSS, maximal urinary flow rate (Q(max)) and postvoid residual volume (PVR). Adverse events were recorded. ResultsA total of 135 men, including 43 in Group A, 48 in Group B and 44 in Group C, completed the study. Relative to baseline, all groups demonstrated significant reductions in OABSS and the IPSS after eight treatment weeks (p<0.005). The improvement of OABSS in Group C was significantly greater than Group A and B (Group A: 0.701.94; Group B: 2.50 +/- 2.98; Group C: 4.30 +/- 3.40; p<0.005). An observed improvement of Q(max) and PVR in the three groups did not achieve statistical significance. Overall adverse event rates were higher in Group C but not significant compared with others. ConclusionIn patients with LUTS and overactive bladder, combined therapy with alfuzosin 10mg plus propiverine 20mg was significantly more effective than alfuzosin monotherapy and propiverine 10mg combined therapy in terms of improving OABSS while not significantly affecting Q(max) or PVR.