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.
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.
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.
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.
Current urology. 2024 Sep 20 [Epub]
Marc Moulin, Erin D Lewis, David C Crowley, Colleen E May, Malkanthi Evans
KGK Science Inc., London, Ontario, Canada., Graminex, L.L.C., Saginaw, MI, USA.