Tadalafil plus tamsulosin is no better than tadalafil alone at improving erectile function and overall urinary symptoms among men with erectile dysfunction (ED) and lower urinary tract symptoms (LUTS), according to a new study. The combination treatment, however, provides greater improvements in maximum urinary flow rate (Qmax) and voiding symptoms.

The findings are from a prospective observational trial that enrolled 75 men with ED and LUTS. Of these, 50 men received tadalafil 5 mg plus tamsulosin 0.4 mg daily and 25 received tadalafil 5 mg plus placebo daily for 12 weeks. At baseline, both groups had similar characteristics and symptom scores as measured using the International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF)-5 questionnaires.

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From baseline to 12 weeks, all men experienced significant improvement IIEF, total IPSS, ssorage-IPSS, and Qmax, Acrangelo Sebastianelli, MD, of the University of Florence in Italy, and collaborators reported in the Journal of Clinical Medicine. At 12 weeks, the combination arm and tamsulosin-placebo arm did not differ significantly with respect to IIEF, total IPSS, and storage IPSS, whereas voiding IPSS and Qmax improvements were significantly better in the combination arm. Mean voiding IPSS decreased from 8.6 at baseline to 5.1 at 12 weeks, a 3.5-point decrease, in the combination arm and from 10 to 8 in the tadalafil monotherapy arm, a 2-point decrease. From baseline to 12 weeks, mean Qmax rose from 10.3 to 14.5, a 4.2-point increase, in the combination arm and from 9.6 to 11.8, a 2.2-point increase, in the tadalafil monotherapy arm.   

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No severe treatment-related adverse events were reported in either group, according to the investigators.


Sebastianelli A, Spatafora P, Frizzi J, et al. Tadalafil 5 mg alone or in combination with tamsulosin 0.4 mg for the management of men with lower urinary tract symptoms and erectile dysfunction: Results of a prospective observational trial. J Clin Med. 2019;8:1126. doi: 10.3390/jcm8081126