AimsWe evaluated long-term efficacy and safety of a combination therapy (CT) with an anticholinergic agent and an 1-blocker for patients with benign prostatic enlargement (BPE) complaining of voiding and overactive bladder (OAB) symptoms, in comparison with those of 1-blocker monotherapy (MT), by conducting a urodynamic study (UDS). MethodsThis was a randomized prospective study involving 120 outpatients with untreated BPE associated with urinary urgency at least once per week and OABSS of 3. The patients were randomly assigned to receive MT with silodosin at 8mg/day or CT with silodosin at 8mg/day and propiverine at 20mg/day. Changes in parameters from baseline to 12 weeks and 1 year after administration were assessed based on IPSS, IPSS-QOL, OABSS, and voiding and storage functions as measured by UDS. ResultsIn efficacy analysis, 53 patients with MT and 51 with CT were included. Although mean IPSS and OABSS significantly improved in both groups, the CT group showed statistically significant improvement in OABSS (-3.4 in CT, -2.4 in MT, P=0.04), IPSS-QOL (-1.9, -1.2, P=0.01), and OAB-urgency score (-1.8, -1.2, P<0.01) at the long-term evaluation. In storage function, both groups showed significant improvements, but the CT group demonstrated a greater improvement in terms of disappearance rate of detrusor overactivity (54.5% in CT, 34.2% in MT, P=0.07) and bladder capacity (+61mL, +33mL, P=0.02). ConclusionsLong-term combination treatment with silodosin and propiverine was effective and safe for BPE patients with voiding and OAB symptoms. Neurourol. Urodynam. 36:748-754, 2017. (c) 2016 Wiley Periodicals, Inc.