BACKGROUND. Phytotherapy has been used to treat patients with lower urinary tract symptoms (LUTS). We evaluated the efficacy and tolerability of combination therapy between Serenoa Repens (SeR), Lycopene (Ly), and Selenium (Se) þ tamsulosin versus single therapies. METHODS. PROCOMB trial (ISRCTN78639965) was a randomized double-blinded, doubledummy multicenter study of 225 patients between 55 and 80 years old, PSA 4 ng/ml, IPSS !12, prostate volume 60 cc, Qmax 15 ml/sec, postvoid residual urine (PVR) <150 ml. Participants were randomized group A (SeR-Se-Ly), group B (tamsulosin 0.4 mg), group C (SeR-Se-Ly þ tamsulosin 0.4 mg). The primary endpoints of the study were the reduction of IPSS, PVR, and increase of Qmax in group C versus monotherapy groups. RESULTS. The decrease for combination therapy was significantly greater versus group A (P < 0.05) and group B (P < 0.01) for IPSS and versus group A (P < 0.01) for PVR from baseline This study has been designed and conducted independently. Konpharma provided support for this study. Data collection and management and all statistical analyses were performed and retained by data manager (R.A.). The corresponding author and other co-authors interpreted the data and participated in the preparation, review and approval of the manuscript. to 6 months. A greater decrease in IPSS was observed for Group C versus group A (P < 0.01) and increase in Qmax versus group B (P < 0.01), from 6 months to 12 months. At one year, the changes of IPSS and Qmax were greater for Group C versus monotherapies (each comparison <0.05). The proportions of men with a decrease of at least three points (each comparison P < 0.05) and decrease of 25% for IPSS (each comparison P < 0.01) were greater for Group C. CONCLUSION. SeR-Se-Ly þ tamsulosin therapy is more effective than single therapies in improving IPSS and increasing Qmax in patients with LUTS.

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We have shown that treatment with SeR-Se-Ly was not inferior to tadalafil 5 mg for improving IPSS and Q in men with LUTS.

Fournier's gangrene is a life-threatening acute necrotizing fasciitis of perianal,genitourinary and perineal areas. Nowadays, is well known that Fournier gangrene is almost never an idiopathic disease. In this article we report a case of a 70-year-old patient that initially was not treated properly. The gold standard therapy of the Fournier's gangrene remains today a complete, early and extended surgical debridement.

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