Moulin Marc, Lewis Erin D, Crowley David C, May Colleen E, Evans Malkanthi
KGK Science Inc., London, Ontario, Canada.
Graminex, L.L.C., Saginaw, MI, USA.
Curr Urol. 2024 Sep;18(3):203-211. doi: 10.1097/CU9.0000000000000248. Epub 2024 Sep 20.
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 ( < 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) ( ≤ 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.
尿失禁（UI）是一种使人衰弱的常见病症，会对生活质量产生不利影响。用于管理尿失禁症状的规范性和手术方法可能会带来不良风险和并发症。这项随机、双盲、安慰剂对照的平行研究调查了两种非溶剂化花粉提取物对健康女性尿失禁的疗效。
114名年龄在40 - 75岁之间、在国际尿失禁咨询问卷 - 尿失禁简表（ICIQ - SF）上得分≥5分的女性被随机分为三组，分别接受Graminex® RCT Fem™ UI、Graminex® PollenBerry®或安慰剂，为期24周。主要结局是补充24周后试验组与安慰剂组之间ICIQ - SF评分的变化。次要结局包括补充6、12、18和24周后夜尿频率（记录在3天排尿日记中）和24小时漏尿量（通过护垫重量评估）的变化，以及补充24周后应激性尿漏量（在完成激发性动作挑战后）的变化。
在第24周时，所有组的ICIQ - SF评分均有改善（<0.001）。RCT Fem™ UI组的ICIQ - SF评分改善最大（-4.07±3.4），其次是PollenBerry®组（-3.34±2.87）和安慰剂组（-2.61±3.52）。RCT Fem™ UI组在24小时漏尿量（-17.68±39.84克）和夜尿频率（-0.52±1.26）方面也有相应改善（≤0.05）。在第24周时，补充PollenBerry®显著改善了应激性尿漏量（-7.12±15.64克）。研究产品在血液学和化学指标方面显示安全。
补充RCT Fem™ UI可显著且在临床上有意义地降低尿失禁严重程度，同时每日尿漏量和夜尿频率也有相应改善。PollenBerry®显著改善了应激性尿漏量，表明它可能对易患应激性尿失禁的女性有效。研究产品在该人群中安全且耐受性良好。
