Real-world outcomes of tadalafil plus mirabegron combination therapy in men with lower urinary tract symptoms and overactive bladder symptoms: a retrospective cohort study.

BACKGROUND

Men with mixed lower urinary tract symptoms (LUTS) often have storage symptoms that drive bother and quality-of-life impairment. Evidence on tadalafil plus mirabegron in routine clinical practice is limited.

OBJECTIVE

To determine whether tadalafil plus mirabegron was associated with clinically meaningful within-person improvement in IPSS and OABSS in men with mixed LUTS and overactive bladder (OAB) symptoms.

METHODS

A single-centre retrospective cohort study of 50 men treated with tadalafil 5 mg plus mirabegron 50 mg. The primary endpoints were within-person change in International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS). Secondary endpoints included bladder diary variables, maximum urinary flow rate (Qmax), post-void residual (PVR) volume, International Index of Erectile Function-5 (IIEF-5), and NIH-Chronic Prostatitis Symptom Index (NIH-CPSI).

RESULTS

Symptoms improved after combination therapy, but the OABSS response was less consistent than the IPSS response. Mean IPSS decreased by 4.18 points (95% CI -4.86 to -3.54; r_rb = -1.00; two-sided P < 0.001) and mean OABSS decreased by 1.86 points (95% CI -2.22 to -1.50; r_rb = -1.00; two-sided P < 0.001). Clinically meaningful IPSS improvement occurred in 38 of 50 men, or 76.0% (95% CI 62.6% to 85.7%); clinically meaningful OABSS improvement occurred in 17 of 50, or 34.0% (95% CI 22.4% to 47.8%). Dual response was seen in 15 of 50 men, or 30.0% (95% CI 19.1% to 43.8%). IIEF-5 increased by 2.92 points (95% CI 2.14 to 3.70; r_rb = 0.86; two-sided P < 0.001). Adverse events were recorded in 3 of 50 men, or 6.0% (95% CI 2.1% to 16.2%), and no patient developed acute urinary retention.

CONCLUSIONS

In men with mixed LUTS and prominent storage symptoms, tadalafil plus mirabegron was associated with improvement in overall symptom burden, bladder diary measures, and erectile-function scores without an obvious retention signal. The clinical benefit was clearer for IPSS than for OABSS, so early reassessment is important to identify men who do not improve.