Comparison of Efficacy and Safety of a Combination of Tamsulosin and Mirabegron versus Tamsulosin Alone in the Management of Overactive Bladder in Males with Lower Urinary Tract Symptoms - TAME-Overactive Bladder: An Open-labeled Randomized Controlled Trial.

Background: Overactive bladder (OAB) is a common condition in elderly men with coexisting benign prostatic enlargement (BPE), and it significantly impairs their quality of life (QoL).

Aim: This study aimed to assess the safety and efficacy of adding beta-3 adrenergic receptor agonist (mirabegron 50 mg) to tamsulosin 0.4 mg for symptomatic men with BPE and OAB symptoms (OABS).

Materials and methods: It was an open-labeled randomized controlled trial. Ninety men with BPE and International Prostate Symptom Score (IPSS) of more than seven with predominant OABS were enrolled for the study. A detailed history, uroflowmetry, and baseline scores, including IPSS, OABS score (OABSS), and QoL assessment, were done for each patient. After written informed consent, patients were randomized into two groups of 45 each. Group-1 received tamsulosin 0.4 mg and placebo, and Group-2 received a combination of tamsulosin 0.4 mg plus mirabegron 50 mg once daily at bedtime. Follow-up of patients was done at 2^nd, 4^th, and 8^th weeks. Efficacy at 8 weeks was assessed using repeat history for symptoms, uroflowmetry, IPSS, OABSS, and QoL score.

Results: After 8 weeks of therapy, collected data were compared to baseline parameters in both groups. Significant improvement with respect to OABSS (P = 0.046), IPSS (P = 0.006), and QoL (P = 0.038) was observed with combination therapy versus tamsulosin alone. There were mild adverse effects, which were self-limiting.

Conclusions: A combination of tamsulosin with mirabegron is effective and safe in improving the OABSS, IPSS, and QoL in men with BPE who have predominant OABS.