Efficacy of propiverine ER with or without α-blockers related to maximum urinary flow rate in adult men with OAB: results of a 12-week, multicenter, non-interventional study

PURPOSE: Comparison of efficacy of propiverine extended release (ER) 30 mg o.d. in the treatment of male OAB administered as monotherapy (MT) or add-on to α-blockers (combination treatment, CT) in relation to maximum urinary flow (Q(max)) in a non-interventional study. METHODS: Men ≥40 years with OAB symptoms, Q(max) ≥10 ml/s, prostate volume <40 ml, post-void residuals (PVR) <100 ml, and IPSS <20 were included. OAB symptoms, IPSS, and PVR were recorded before and after 12 weeks of treatment. Participants were stratified by Q(max) (group A ≥15 ml/s, group B <15 ml/s) and CT vs. MT. Safety parameters were monitored. RESULTS: A total of 2,219 men participated and were involved in safety analysis; 1,849 men (mean age 66 years) fulfilled the inclusion criteria and were involved in efficacy analysis. In group A, 291 men received MT and 479 CT; in group B, 184 men received MT and 895 CT. OAB symptoms improved significantly in all groups throughout the study without differences between MT and CT. IPSS improvement in group B was less with MT than with CT (−3.9 vs. −5.2; P < 0.001), whereas IPSS improvement was similar in group A (−4.6 vs. −5.1). Mean PVR change was not clinically relevant, but two men (0.1%) experienced urinary retention. CONCLUSIONS: Under real-life conditions, treatment of OAB symptoms with propiverine ER is equally effective in men with MT or CT regardless of baseline Q(max). In men with reduced Q(max), IPSS improvement is significantly smaller with MT. The incidence of urinary retention during propiverine ER treatment is low.