A randomized controlled trial comparing the efficacy of the combination treatment with tamsulosin plus solifenacin and tamsulosin alone for overactive bladder related with benign prostatic hyperplasia

Abstract

Objective: To compare the efficacy of lower urinary tract symptoms (LUTS) relief in patients who had benign prostatic hyperplasia (BPH) and symptoms of overactive bladder (OAB) taking tamsulosin with placebo and tamsulosin with solifenacin. Design: Randomized double-blind placebo controlled trial Setting: King Chulalongkorn Memorial hospital which is a tertiary care center Research Methodology: Fifty five patients, mean age 66.6 years with LUTS from BPH and OAB symptoms were randomly allocated into two groups after receiving tamsulosin for 2 weeks. Control group received tamsulosin with placebo (vitamin C). Treatment group received tamsulosin with solifenacin. Both groups had 4 week course of study. Efficacy outcomes were recorded including IPSS score, OAB screener score and Bladder Sensation Scale. Safety and tolerability outcomes were uroflowmetry monitoring and any adverse events. Results: Patients who receive both tamsulosin and solifenacin (treatment group) were significantly decreased in irritative symptom score and bladder sensation scale (P=0.005, P=0.49 respecticely). No difference in maximum urinary flow rate and residual urine was observed. Adverse events were found in treatment group more common than in control group, especially dry mouth and constipation (P=0.005, P<0.001). Conclusion: Combination of tamsulosin (adrenergic blockade) and solifenacin (antimuscarinic agent) demonstrated significant reduction of irritative symptoms and Bladder sensation scale in BPH patient including quality of life score from IPSS. No difference in maximum flow rate and post-void residual urine in both groups were observed. Adverse events were found in treatment group more often than in control group especially dry mouth and constipation. Although most adverse reactions were mild and did not disturb patients’ quality of life.