Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV, non‐inferiority, open‐label, clinical study (SPRITE study). (16th April 2018)

• Record Type: Journal Article
• Authors: Morgia, Giuseppe; Vespasiani, Giuseppe; Pareo, Rosaria M.; Voce, Salvatore; Madonia, Massimo; Carini, Marco; Ingrassia, Antonio; Terrone, Carlo; Gentile, Marcello; Carrino, Maurizio; Giannantoni, Antonella; Blefari, Franco; Arnone, Salvatore; Santelli, Giorgio; Russo, Giorgio I.
• Other Names: Reale Giulio investigator.; Di Mauro Marina investigator.; Fedelini Paolo investigator.; Pucci Luigi investigator.; Veneziano Pasquale investigator.; Santaniello Francesco investigator.; Ginepri Andrea investigator.; Bitelli Marco investigator.; Valerio Beatrici M. investigator.; Polledro Patrizio investigator.; La Rosa Pasquale investigator.; Chiancone Francesco investigator.; Giannella Riccardo investigator.; Del Fabbro Dario investigator.; Farullo Giuseppe investigator.; Cocci Andrea investigator.; Lanciotti Michele investigator.; Solinas Tatiana investigator.; Di Dio Agata investigator.; Dal Pozzo Claudio investigator.; Palmieri Fabiano investigator.; Zaganelli Stefano investigator.; Lacetera Vito investigator.
• Is Part Of: BJU international. Volume 122:Number 2(2018)
• Page Start: 317
• Page End: 325
• Publication Date: 2018-04-16
• Subjects: benign prostatic enlargement -- LUTS -- Serenoa repens -- tadalafil -- prostate; Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.14209
• Languages: English
• ISSNs: 1464-4096

Abstract

Abstract : Objective: To compare in a randomised, open‐label, non‐inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR‐Se‐Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms (LUTS). Patients and methods: From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ISRCTN] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score (IPSS) ≥12, maximum urinary flow rate ( Q max ) ≤ 15 mL/s, and post‐void residual (PVR) <100 mL. Patients were randomised into two groups in a 2:1 ratio: Group A (SeR‐Se‐Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non‐inferior variation in the IPSS and Q max in Group A vs Group B after 6 months of treatment. Results: In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (−3.0 vs −3.0; P < 0.01), IPSS quality of life (−2.0 vs −2.0; P < 0.05), and Q max (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Q max (38.2% vs 28.1%; P = 0.04) and of at least 30% of Q max (39.2% vs 27.3%; P < 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) ( P < 0.05) reported side‐effects. Conclusion: We have shown that treatment with SeR‐Se‐Ly was not inferior to tadalafil 5 mg for improving IPSS and Q max in men with LUTS.