CONTEXT: The effects of combination therapy consisted of an α-blocker and a phosphodiesterase-5 inhibitor (PDE5I) for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). OBJECTIVE: To systematically investigate the efficacy and safety of combination therapy in comparison with monotherapy. EVIDENCE ACQUISITION: The study complied with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement and the recommendations of the European Association of Urology Guidelines office. The study was registered in the PROSPERO database with ID CRD42018086619. Only comparative prospective studies, randomized or quasirandomized, with at least one control group with monotherapy were selected for the meta-analysis. The primary endpoint was the quality of life related to LUTS and ED, measured with the International Prostate System Score (IPSS), maximum flow rate (Qmax), postvoid residual (PVR), and International Index of Erectile Function (IIEF). Secondary endpoints included the adverse events rate. In the subgroup analysis of the influence of adding a PDE5I to the treatment of LUTS, the use of different PDE5Is was considered. EVIDENCE SYNTHESIS: After the screening of 6687 publications, 25 randomized controlled trials were considered eligible to be included in the meta-analysis. In the combination group, IPSS was lower and Qmax was higher than in the α-blocker group, with mean differences (MDs) of 1.41 (95% confidence interval [CI]: 0.42, 2.41; I2 = 71%, p = 0.005) and -1.01 ml/s (95% CI: -1.58, -0.43; I2 = 58%, p = 0.0006), respectively. The mean change of the IPSS was bigger in the combination group, with an MD of -1.72 (95% CI: -2.55, -0.89; I2 = 37%, p < 0.0001). The mean change of Qmax was insignificant, with an MD of -0.61 (95% CI: -1.57, 0.34; I2 = 63%, p = 0.21), as well as PVR and the mean change of PVR, with MDs of 0.65 (95% CI: -5.37, 6.66; I2 = 76%, p = 0.83) and -20.79 (95% CI: -48.94, 7.37; I2 = 75%, p = 0.15), respectively. The IIEF and the mean change of the IIEF had no difference between the combination group and the PDE5I-monotherapy group, with MDs of 1.82 (95% CI: -0.91, 4.54; I2 = 40%, p = 0.19) and 0.25 (95% CI: -1.11, 1.62; I2 = 47%, p = 0.72), respectively. Regarding the adverse events, the meta-analysis was in favor of monotherapy. None of the studies reported any serious or severe adverse event. CONCLUSIONS: Treatment with combination therapy is more effective for the improvement of the IPSS. Less significant improvement was shown in Qmax. The beneficial effect of combination therapy regarding ED remains equivocal. The combination therapy seemed to be safe and well tolerated. PATIENT SUMMARY: In this study, we review the effects of the combination therapy consisting of an α-blocker and a phosphodiesterase-5 inhibitor for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). We found strong evidence to suggest the combination therapy for the improvement of LUTS. Benefits regarding the treatment of ED are less clear.
CONTEXT: The effects of combination therapy consisted of an α-blocker and a phosphodiesterase-5 inhibitor (PDE5I) for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). OBJECTIVE: To systematically investigate the efficacy and safety of combination therapy in comparison with monotherapy. EVIDENCE ACQUISITION: The study complied with the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement and the recommendations of the European Association of Urology Guidelines office. The study was registered in the PROSPERO database with ID CRD42018086619. Only comparative prospective studies, randomized or quasirandomized, with at least one control group with monotherapy were selected for the meta-analysis. The primary endpoint was the quality of life related to LUTS and ED, measured with the International Prostate System Score (IPSS), maximum flow rate (Qmax), postvoid residual (PVR), and International Index of Erectile Function (IIEF). Secondary endpoints included the adverse events rate. In the subgroup analysis of the influence of adding a PDE5I to the treatment of LUTS, the use of different PDE5Is was considered. EVIDENCE SYNTHESIS: After the screening of 6687 publications, 25 randomized controlled trials were considered eligible to be included in the meta-analysis. In the combination group, IPSS was lower and Qmax was higher than in the α-blocker group, with mean differences (MDs) of 1.41 (95% confidence interval [CI]: 0.42, 2.41; I2 = 71%, p = 0.005) and -1.01 ml/s (95% CI: -1.58, -0.43; I2 = 58%, p = 0.0006), respectively. The mean change of the IPSS was bigger in the combination group, with an MD of -1.72 (95% CI: -2.55, -0.89; I2 = 37%, p < 0.0001). The mean change of Qmax was insignificant, with an MD of -0.61 (95% CI: -1.57, 0.34; I2 = 63%, p = 0.21), as well as PVR and the mean change of PVR, with MDs of 0.65 (95% CI: -5.37, 6.66; I2 = 76%, p = 0.83) and -20.79 (95% CI: -48.94, 7.37; I2 = 75%, p = 0.15), respectively. The IIEF and the mean change of the IIEF had no difference between the combination group and the PDE5I-monotherapy group, with MDs of 1.82 (95% CI: -0.91, 4.54; I2 = 40%, p = 0.19) and 0.25 (95% CI: -1.11, 1.62; I2 = 47%, p = 0.72), respectively. Regarding the adverse events, the meta-analysis was in favor of monotherapy. None of the studies reported any serious or severe adverse event. CONCLUSIONS: Treatment with combination therapy is more effective for the improvement of the IPSS. Less significant improvement was shown in Qmax. The beneficial effect of combination therapy regarding ED remains equivocal. The combination therapy seemed to be safe and well tolerated. PATIENT SUMMARY: In this study, we review the effects of the combination therapy consisting of an α-blocker and a phosphodiesterase-5 inhibitor for the treatment of lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). We found strong evidence to suggest the combination therapy for the improvement of LUTS. Benefits regarding the treatment of ED are less clear.