Aims: To evaluate the efficacy and safety of combination therapy comprising a short-acting anticholinergic, imidafenacin and an alpha-blocker compared with monotherapy with an alpha-blocker only in men with lower urinary tract symptoms (LUTS) and storage symptoms. Methods: The 12-week, prospective, double-blind, randomised trial enrolled men with LUTS and storage symptom. The inclusion criteria were a total International Prostate Symptom Score (IPSS) ≥12, an IPSS question 4 score ≥2, ≥8 micturitions in 24 hours, and a prostate volume >20 mL. The primary outcome was a change in the micturition number from baseline. Bladder diary variables, Patient Perception of Intensity of Urgency Scale (PPIUS) scores, IPSS and safety were assessed. Results: Of 260 patients screened, 221 completed the study. Patients were randomly assigned to receive an alpha-blocker only (n=111, group 1) or combination therapy comprising an alpha-blocker and an anticholinergic (n=110, group 2) for 12 weeks. Group 1 and 2 showed significant improvement in their 24-hour micturition numbers (−1.87 and −2.08, respectively), nocturia episodes (−0.48 and −0.53, respectively), total IPSS (−9.9 and −8.8, respectively), and PPIUS scores (−0.19 and −0.24, respectively). Micturition number per 24 hours, daytime frequency, urgency, the PPIUS score, the IPSS question 4 score and IPSS QoL score improved significantly in the combination therapy group, but changes in total IPSS, nocturia episodes, and safety outcomes did not differ significantly between the groups. Conclusions and clinical implications: Compared with treatment with an alpha-blocker alone, combination therapy comprising an anticholinergic and an alpha-blocker showed superior efficacy and its safety was similar in patients with LUTS and storage symptoms.
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