Real-world outcomes of tadalafil plus mirabegron combination therapy in men with lower urinary tract symptoms and overactive bladder symptoms: a retrospective cohort study
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 50 participants or records.
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