1. 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)
- Author
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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., Reale, Giulio, Di Mauro, Marina, Fedelini, Paolo, Pucci, Luigi, Veneziano, Pasquale, Santaniello, Francesco, Ginepri, Andrea, Bitelli, Marco, Valerio Beatrici, M., Polledro, Patrizio, La Rosa, Pasquale, Chiancone, Francesco, Giannella, Riccardo, Del Fabbro, Dario, Farullo, Giuseppe, Cocci, Andrea, Lanciotti, Michele, Solinas, Tatiana, Di Dio, Agata, Dal Pozzo, Claudio, Palmieri, Fabiano, Zaganelli, Stefano, and Lacetera, Vito
- Subjects
Male ,benign prostatic enlargement ,LUTS ,prostate ,Serenoa repens ,tadalafil ,medicine.medical_specialty ,Urology ,030232 urology & nephrology ,Prostatic Hyperplasia ,Group B ,law.invention ,Tadalafil ,03 medical and health sciences ,Selenium ,0302 clinical medicine ,Lycopene ,Randomized controlled trial ,Lower Urinary Tract Symptoms ,law ,Lower urinary tract symptoms ,Serenoa ,medicine ,Clinical endpoint ,80 and over ,Humans ,Adverse effect ,Benign prostatic enlargement ,Prostate ,Aged ,Aged, 80 and over ,business.industry ,Plant Extracts ,Middle Aged ,Phosphodiesterase 5 Inhibitors ,medicine.disease ,Drug Combinations ,Treatment Outcome ,Tolerability ,030220 oncology & carcinogenesis ,Tablets ,Urological Agents ,International Prostate Symptom Score ,business ,medicine.drug - 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 (Qmax ) ≤ 15 mL/s, and post-void residual (PVR)
- Published
- 2018