We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
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).
- Authors
on behalf of the SPRITE investigators; Morgia, Giuseppe; Russo, Giorgio I.; Carrino, Maurizio; Giannantoni, Antonella; Blefari, Franco; Arnone, Salvatore; Santelli, Giorgio; Vespasiani, Giuseppe; Pareo, Rosaria M.; Voce, Salvatore; Madonia, Massimo; Carini, Marco; Ingrassia, Antonio; Terrone, Carlo; Gentile, Marcello
- 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) <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 Qmax 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 Qmax (2.0 vs 2.0 mL/s; P < 0.01). We found statistically significant differences in the increase of at least 3 points in Qmax (38.2% vs 28.1%; P = 0.04) and of at least 30% of Qmax (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 Qmax in men with LUTS.
- Subjects
SELENIUM; LYCOPENE; URINARY organs; URINARY tract infections; TADALAFIL
- Publication
BJU International, 2018, Vol 122, Issue 2, p317
- ISSN
1464-4096
- Publication type
Article
- DOI
10.1111/bju.14209