Mirabegron and Tamsulosin Co-Therapy Outperforms Monotherapy for Benign Prostatic Hyperplasia: Study

To perform a definitive comparison clinically between both treatment approaches, a phase III randomized, double-blind, placebo-controlled clinical trial was conducted by the researchers. The study was carried out across 25 urology centers over the period ranging from July 2021 to October 2023. Randomization was performed in a strict 1:1 ratio between both groups of eligible male patients suffering from moderately severe LUTS associated with BPH and receiving a combination treatment or a monotherapy of tamsulosin for 12 weeks of treatment duration.

Primary efficacy measures were the changes from baseline in TUFS and IPSS. Secondary efficacy parameters measured were selected voiding diary measurements, PVR, Q max, and quality of life scores. For safety parameters assessment, adverse events, laboratory values, vital signs, and electrocardiograms were all assessed over time during the treatment period.

Key findings:

• A total of 795 subjects were randomized into two groups, comprising 397 for monotherapy and 398 for combination therapies, with 342 and 339 participants completing the 12-week course of treatment, respectively.
• There was more decline (-11.28 vs -8.30, P < 0.0001) in TUFS observed in the combination therapy group than in the monotherapy group.
• Also noted was a more pronounced decline in IPSS by -10.85 in the combination therapy group versus -9.85 in the monotherapy group (P = 0.0325).
• Subjects on combination therapy had significant improvement in storage symptoms with notable decrease in daily urge episodes, daytime frequency, and incontinence as compared with patients on tamsulosin monotherapy.
• Treatment-emergent adverse reactions occurred in 16.58% (66 out of 398) of the combination group and 13.10% (52 out of 397) of the monotherapy group; however, this difference was statistically non-significant (P = 0.1943).
• Most importantly, no serious drug-related adverse events were documented throughout the entire 12 weeks.

In summary, this phase III randomized controlled trial proves beyond doubt that a combination therapy of mirabegron and tamsulosin is more efficacious compared to monotherapy, especially regarding storage symptoms of LUTS associated with benign prostatic hyperplasia, without compromising the safety of such a combination therapy. This strong evidence definitely gives an indication for current urological practice to move away from traditional monotherapy alpha-blockers among men with ongoing urinary frequency and urgency complaints.

Reference:

Kam SC, Shin YS, Kim DS, Lee WK, Han DH, Song PH, Hong SH, Chang YS, Kim TH, Cho ST, Park SY, Bae JH, Chung KJ, Noh JH, Cho KS, Kim TN, Luo Z, Ham WS, Kim TH. 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. World J Mens Health. 2026 Apr;44(2):427-437. https://doi.org/10.5534/wjmh.250085