Efficacy of nonsolvent flower pollen extracts in healthy women with urinary incontinence: A randomized, double-blind, placebo-controlled, parallel study

Abstract

Background: Urinary incontinence (UI) is a debilitating and common condition that adversely affects quality of life. Prescriptive and surgical approaches for managing UI symptoms may result in undesirable risks and complications. This randomized, double-blind, placebo-controlled, parallel study investigated the efficacy of 2 nonsolvent flower pollen extracts on UI in healthy women.

Materials and methods: One-hundred and fourteen women aged 40-75 years who scored ≥5 on the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-SF) were randomized to receive either Graminex® RCT Fem™ UI, Graminex® PollenBerry®, or placebo for 24 weeks. The primary outcome was the change in the ICIQ-SF score between the trial and placebo groups after 24 weeks of supplementation. The secondary outcomes included changes in the frequency of nocturia (recorded in 3-day void diaries) and 24-hour leakage volume (assessed via pad weight) after 6, 12, 18, and 24 weeks of supplementation and changes in stress-induced urinary leakage volume (after completion of a provocative maneuver challenge) after 24 weeks of supplementation.

Results: All the groups demonstrated improvement in ICIQ-SF scores at week 24 (p < 0.001). The RCT Fem™ UI group had the greatest improvement in ICIQ-SF scores (-4.07 ± 3.4), followed by the PollenBerry® group (-3.34 ± 2.87) and placebo group (-2.61 ± 3.52). The RCT Fem™ UI group had corresponding improvements in 24-hour leakage volume (-17.68 ± 39.84 g) and frequency of nocturia (-0.52 ± 1.26) (p ≤ 0.05). PollenBerry® supplementation significantly improved stress-induced urinary leakage volume (-7.12 ± 15.64 g) at week 24. The study products demonstrated safe hematological and chemical profiles.

Conclusions: RCT Fem™ UI supplementation resulted in significant and clinically meaningful reductions in UI severity, with corresponding improvements in daily urinary leakage volume and frequency of nocturia. PollenBerry® significantly improved stress-induced urinary leakage volume, suggesting that it may be efficacious in women who are prone to stress UI. The study products were safe and well tolerated in this population.

Keywords: Dietary supplement; Healthy women; ICIQ-SF; Pollen extract; Urinary incontinence; Urinary leakage.