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.

In 285 patients with prevesical ureteral stone and 247 with upper ureteral stone, extracorporeal shock wave lithotripsy (ESWL) was performed with the Dornier MPL 9000 ultrasonographic targeting device. All these stones were treated "in situ" and without regional or general anaesthesia. At 3-month follow-up 96.8% of the patients treated for prevesical stone and 95.5% of those with upper ureteral stone were stone-free. ESWL was repeated once or twice in 99 cases; the average number of sessions was 1.2 for all patients (similar for prevesical and upper ureteral stones). Sparse use of ureteral stenting (6.2% of cases) did not seem to reduce the efficacy of ESWL or increase complications or need for retreatment. Intravenous fentanyl analgesia was given to 40.9% of the patients and intravenous infusion of a furosemide solution was employed in many cases to give adequate dilation of the urinary tract. In situ echo-guided ureteral ESWL is simple, safe and efficacious and can be the technique of choice for sonographically detectable ureteral stone.

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