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Efficacy of nonsolvent flower pollen extracts in healthy women with urinary incontinence: A randomized, double-blind, placebo-controlled, parallel study.
- Source :
-
Current urology [Curr Urol] 2024 Sep; Vol. 18 (3), pp. 203-211. Date of Electronic Publication: 2024 Sep 20. - Publication Year :
- 2024
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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.<br />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.<br />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.<br />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.<br />Competing Interests: 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.<br /> (Copyright © 2024 The Authors. Published by Wolters Kluwer Health, Inc.)
Details
- Language :
- English
- ISSN :
- 1661-7649
- Volume :
- 18
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Current urology
- Publication Type :
- Academic Journal
- Accession number :
- 39219633
- Full Text :
- https://doi.org/10.1097/CU9.0000000000000248