Self-Assessed Benefits of a Prostate Health Formulation on Nocturia in Healthy Males With Mild Lower Urinary Tract Symptoms: An Open Label Study

Abstract

Background Nocturia is the most bothersome lower urinary tract symptoms (LUTS) and can significantly reduce men's quality of life. It is often poorly managed with conventional treatments. Objective The purpose of this study was to evaluate the self-assessed benefits of a prostate health dietary combination formulation on mild LUTS, especially nocturia in healthy males. Methods In an open label clinical study, thirty healthy male subjects with mild LUTS took one daily capsule of the product for 60 days. The primary outcome was self-assessed severity of LUTS using the International Prostate Symptoms Score (IPSS) questionnaire at Day 1 (baseline), Day 30 and Day 60. Safety and compliance were also evaluated. Results At Day 60, IPSS significantly decreased from baseline by 16.3% (3.6 ± 2.1 vs. 4.3 ± 1.5, p < 0.05). Although the reduction in IPSS did not reach statistical significance at Day 30, it was mostly driven by a 30.7% decrease (p < 0.05) in the nocturia sub-score compared with baseline. While 37% of subjects reported at baseline waking up 2‒3 times/night to void, none did so after taking the study product for 60 days. Compliance was very high throughout the study. No adverse events related to the study product were reported. Conclusions The study product might be a safe alternative for individuals willing to explore a non-conventional approach to manage their nocturia. A larger randomized placebo-controlled clinical trial is warranted to confirm these results. Clinical trial registry: Clinical Trials.gov. Registration number (September 1st, 2016): NCT02886832.