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

Urinary incontinence / Pollen extract / Healthy women / Dietary supplement / ICIQ-SF / Urinary leakage

Author summay

Supplemental Digital Content is available for this article.

Acknowledgments

The authors wish to thank the participants for their compliance to the conduct of the study.

Statement of ethics

This study was approved by the Natural and Non-Prescription Health Products Directorate, Health Canada, Ottawa, Ontario, Canada, and ethical approval was granted by the IRB Services, Aurora, Ontario, Canada (Pro00033511). The study was conducted in compliance with the International Council for Harmonization of Technical Requirements for harmaceuticals for Human Use Guidelines for Good Clinical Practice guidelines and in accordance with the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all participants before study initiation. This study was registered at ClinicalTrials.gov (NCT05510999).

Conflict of interest statement

CEM is an employee of Graminex, L.L.C. MM, EDL, DCC, and ME are employees of KGK Science Inc. and have no competing interests to declare.

Funding source

This study was funded by Graminex L.L.C. (Saginaw, MI, USA).

Author contributions

MM: Data interpretation, visualization, writing—original draft preparation, review, and editing; EDL: Writing—original draft preparation, review, and editing;

DCC: Study supervision;

CEM: Study design, writing—review and editing;

ME: Study design, data interpretation, writing—original draft preparation, review and editing, and supervision;

All the authors have read and approved the final version of the manuscript.

Data availability

The datasets generated during and/or analyzed during the current study are not publicly available, but are available from the corresponding author on reasonable request.

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