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 compli...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.展开更多
文摘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.
