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
Abstract
Purpose This study aimed to evaluate the efficacy and safety of mirabegron and tamsulosin combination therapy compared to tamsulosin monotherapy in benign prostatic hyperplasia (BPH) patients with lower urinary tract symptoms (LUTS). Materials and Methods This phase 3, randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of mirabegron/tamsulosin combination therapy versus tamsulosin monotherapy in men with LUTS. The trial, conducted across 25 centers from July 2021 to October 2023. Eligible participants were randomly assigned to either the combination or monotherapy group for 12 weeks. Primary efficacy endpoints included changes in total urinary frequency score (TUFS) and International Prostate Symptom Scores (IPSS), with secondary endpoints evaluating various urinary symptoms and changes in post void residual volume (PVR), maximum urinary flow rate (Qmax), and quality of life scores. Safety assessments included adverse events, PVR, Qmax, vital signs, electrocardiogram, and laboratory tests. Results A total of 795 participants were randomized to monotherapy (n=397) and combination therapy (n=398) groups. After 12 weeks, 342 in the monotherapy and 339 in the combination therapy group completed the study, with no significant baseline differences. The combination therapy group showed a greater improvement in TUFS (-11.28) and IPSS (-10.85) scores compared to monotherapy (-8.30 and -9.85, respectively) with significant differences…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 795 participants or records.
Read the paper
Related studies
- Treatment of non-metastatic castration-resistant prostate cancer: facing age-related comorbidities and drug–drug interactions
- The Efficacy of Flogofilm® in the Treatment of Chronic Bacterial Prostatitis as an Adjuvant to Antibiotic Therapy: A Randomized Prospective Trial
- Inhibition of growth and contraction in human prostate stromal cells by silencing of NUAK1 and -2, and by the presumed NUAK inhibitors HTH01-015 and WZ4003
- Effectiveness and Safety of a New Nutrient Fixed Combination Containing Pollen Extract Plus Teupolioside, in the Management of LUTS in Patients with Benign Prostatic Hypertrophy: A Pilot Study
- Extract from Cucurbita pepo improves BPH symptoms without affecting sexual function: a 24-month noninterventional study
- Aquablation vs. holmium laser enucleation of the prostate for benign prostatic hyperplasia: a 150-patients prospective comparative multicenter study
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.