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September 10, 2025The World Journal of Men s HealthOpen Access

Efficacy and Safety of Mirabegron and Tamsulosin Combination Therapy Compared to Tamsulosin Monotherapy for Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: Results of a Multicenter, Randomized, Double-Blind, Phase III Clinical Trial

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Authors

SKSung Chul KamChangwon National UniversityYSYu Seob ShinChonbuk National University HospitalDKDoo Sang KimSoonchunhyang University

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Implication

Randomized trial demonstrated improved LUTS in BPH patients with combination therapy, indicating its safety profile.

Key Points

  • Combination therapy improved total urinary frequency score by -11.28 compared to -8.30 with monotherapy, showing significant efficacy.
  • The study involved 795 participants over 12 weeks, with similar adverse event rates between groups (13.10% vs 16.58%, p=0.1943).
  • Phase III, randomized, double-blind trial conducted across 25 centers evaluating treatment efficacy for LUTS.
  • Combination therapy showed acceptable safety, emphasizing its potential for improving patient adherence and quality of life.

Cite This Study

Kam et al. (2025) studied this question.

synapsesocial.com/papers/68c1ac0154b1d3bfb60e468dhttps://doi.org/10.5534/wjmh.250085
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1The Prevalence of Benign Prostate Hyperplasia in Korea: Using National Health Insurance Service Data2018 · 11 citations
  2. 2A proof‐of‐concept study: Mirabegron, a new therapy for overactive bladder2013 · 97 citations
  3. 3Urodynamic Efficacy and Safety of Mirabegron Add‐on Treatment with Tamsulosin for Japanese Male Patients with Overactive Bladder2015 · 31 citations
  4. 4The Efficacy and Safety of Combination Therapy with Alpha-Blocker and Low-Dose Propiverine Hydrochloride for Benign Prostatic Hyperplasia Accompanied by Overactive Bladder Symptoms2009 · 6 citations
  5. 5Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I—Initial Work-up and Medical Management2021 · 404 citations