PurposeRecently, several randomized controlled trials (RCTs) explored the effects of -blockers with or without phosphodiesterase type 5 inhibitors (PDE5-Is) for lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH). However, the results were inconsistent. We performed this meta-analysis to evaluate the role of combination therapy (-blockers and PDE5-Is) in patients with LUTS/BPH.Materials and methodsDatabases including PubMed, Cochrane library, Web of Science, and Embase were searched for qualified RCTs. Pooled mean differences (MDs) and odds ratios (ORs) were calculated to measure the effects and adverse events in combination therapy. Moreover, subgroup analyses of ethnicity, dosage of PDE5-Is, treatment duration, and severity of LUTS/BPH were performed. In addition, trial sequential analyses (TSAs) were used to assess whether the evidence for the results was sufficient.ResultsOverall, this study identified 11 eligible RCTs, including 855 LUTS/BPH patients. Patients receiving combination therapy had better improvement in international prostate symptom score (IPSS: MD: 1.66, 95% CI -3.03 to -0.29), maximum urinary flow rate (Q(max): MD: 0.94, 95% CI 0.24-1.64), and international index of erectile function (IIEF: MD: 4.73, 95% CI 2.95-6.51), comparing those without PDE5-Is. Besides, subgroup analyses indicated that the effects of combination treatment were associated with ethnicity, treatment duration, and severity of LUTS/BPH. By TSA, the findings in the current study were based on sufficient evidence.ConclusionsOur results indicated that combination therapy can significantly improve IPSS, Q(max), and IIEF in patients with LUTS/BPH. Combination therapy might be more suitable for these patients.