Effects of initial combined tamsulosin and solifenacin therapy for overactive bladder and bladder outlet obstruction secondary to benign prostatic hyperplasia: A prospective, randomized, multicenter study

Purpose: The purpose of the study is to evaluate the clinical efficacy of initial combined therapy of an alpha-blocker and anticholinergic agent compared with the alpha-blocker alone in patients with benign prostatic hyperplasia (BPH) with overactive bladder (OAB). Methods: Hundred and fifty-six BPH patients with International Prostate Symptom Score (IPSS) of over 14 (voiding sub-score ≥8 and storage sub-score ≥6) were prospectively included in Korea. Group 1 (n = 69) was the patients who were treated with Tamsulosin 0.2 mg daily alone for 4 weeks and after 8 weeks they were treated with tamsulosin 0.2 mg and solifenacin 5.0 mg daily combination. Group 2 (n = 70) was the patients who were treated initially with tamsulosin 0.2 mg and solifenacin 5.0 mg combination for 12 weeks. Detailed questionnaires were used to assess treatment satisfaction at 4th week and at 12th week of treatment in 2 groups. Results: Baseline characteristics were not different between the 2 groups. In the 4th week, there was no difference between the 2 groups with regard to IPSS total score and voiding symptom score, although the IPSS storage symptom score was significantly lower in the Group 2 [-2.0 (0.2) Δ23.8 vs. -3.0 (0.2) Δ35.7] (P < 0.001). In the 12th week, there was improvement in storage indices such as IPSS storage symptom score, OABSS, and urgency symptoms compared with baseline in each group (P < 0.001). No statistical differences in storage indices observed between the two groups at 12 week. Conclusions: Earlier treatment with alpha-blocker and anticholinergic agent helped to improve storage symptoms and quality-of-life scores earlier for patients with lower urinary tract symptoms related to BPH and OAB symptoms.