Serenoa repens + selenium + lycopene vs. tadalafil 5 mg for the treatment of LUTS secondary to benign prostatic obstruction: a phase IV, non-inferiority, open label, clinical study (SPRITE Study).

BJU Int. 2018 Mar 22. doi: 10.1111/bju.14209. [Epub ahead of print] Morgia G1, Vespasiani G2, Pareo RM3, Voce S4, Madonia M5, Carini M6, Ingrassia A7, Terrone C8, Gentile M9, Carrino M10, Giannantoni A11, Blefari F12, Arnone S13, Santelli G14, Russo GI1; SPRITE investigators. Author information 1 Urology section - Department of Surgery, University of Catania, 95125, Italy. 2 Urology section - University of Tor Vergata, Rome, 00100, Italy. 3 Urology section - Regina Margherita Hospital, Rome, 00100, Italy. 4 Urology section -, Ravenna, Hospital, Ravenna, 48121, Italy. 5 Urology section - Department of Surgery,, University of Sassari, 07100, Italy. 6 Department of Urology, University of Florence, Florence, 50100, Italy. 7 Urology section, Acireale Hospital, Acireale, 95024, Italy. 8 Urology section, University of Genova, Genova, 16121, Italy. 9 Urology section, Civic Hospital, Avellino, 83100, Italy. 10 Urology section, Cardarelli Hospital, Napoli, 80017, Italy. 11 Department of Urology, University of Perugia, Perugia, 06121, Italy. 12 Urology section, Prato Hospital, Prato, 59100, Italy. 13 Urology section, Lugo of Romagna Hospital, Ravenna, 48121, Italy. 14 Urology section, Lucca Hospital, Lucca, 55100, Italy. Abstract INTRODUCTION: In this randomized, open label, not-inferior clinical study, we aimed to compare the efficacy and tolerability of Serenoa Repens (SeR) + Lycopene (Ly) + Selenium (Se) therapy versus Tadalafil 5 mg in patients affected by lower urinary tract symptoms (LUTS). METHODS: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (ISRCTN73316039). Inclusion criteria were: age between 50 and 80 years old, international prostate symptom score (IPSS) ≥ 12, peak flow ≤15 ml/s, post-void residual (PVR) <100 ml. Participants were randomized into 2 arms in a 2:1 ratio: arm A (SeR-Se-Ly 1 tablet per day for 6 months) and arm B (Tadalafil 5 mg 1 tablet per day for 6 months). The primary endpoint of the study was the non-inferiority variation of the IPSS and peak flow in Group A vs. Group B after 6 months of treatment. RESULTS: 404 patients completed the full protocol. When comparing both therapies, group A was statistically not inferior to Group B considering IPSS (-3.0 vs. - 3.0; p <0.01), IPSS-QoL (-2.0 vs. -2.0; p<0.05) and peak flow (2.0 vs. 2.0; p<0.01). We found statistically significant differences in the increase of at least 3 points of the peak flow (38.2% versus 28.1%; p = 0.04) and at least 30% of the peak-flow (39.2% versus 27.3%; p <0.01) in arm A compared to arm B. The percentage of patients with an increase of at least 3 points of the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two arms. Regarding the percentage of adverse events, 4 patients in arm A (1.44%) and 10 arm B (7.81%) (p <0.05) referred side effects. CONCLUSION: We have shown that treatment with SeR-Se-Ly was not inferior to Tadalafil 5 mg in terms of improving of IPSS and peak flow. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved. KEYWORDS: LUTS ; Benign prostatic enlargement; Tadalafil; prostate; serenoa repens PMID: 29569389 DOI: 10.1111/bju.14209