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 Tri

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).

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).

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 2nd, 4th, and 8th weeks. Efficacy at 8 weeks was assessed using repeat history for symptoms, uroflowmetry, IPSS, OABSS, and QoL score.

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.

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.

International journal of applied & basic medical research. 2023 Dec 08 [Epub]

Azhar Anwar, Vivek Gorka, Harmandeep Singh Chahal, Sandeep Sharma, Sunit Tandon, Naman Singhal, Pankaj Chandrakant Narwade, Nikhil Chauhan, Namita Bansal, Simran Kaur

Department of Urology, Galaxy Hospital, Varanasi, Uttar Pradesh, India., Department of Urology, Fortis Hospital, Amritsar, Punjab, India., Department of Urology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India., Department of Research and Development, Dayanand Medical College and Hospital, Ludhiana, Punjab, India., Department of Nephrology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.