The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence.
1 other identifier
interventional
190
1 country
1
Brief Summary
The primary objective of this study is to investigate the effect of Graminex® Flower Pollen Extracts in healthy women with urinary incontinence. The change in severity of urinary incontinence between baseline and 24 weeks will be assessed by an International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and compared between the investigational product and placebo groups. Additionally, the safety and tolerability of Graminex® Flower Pollen Extracts, as compared to placebo, will be measured by the occurrence of and/or changes in treatment-emergent adverse events (AEs).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 26, 2021
CompletedFirst Submitted
Initial submission to the registry
August 18, 2022
CompletedFirst Posted
Study publicly available on registry
August 22, 2022
CompletedAugust 22, 2022
August 1, 2022
2.4 years
August 18, 2022
August 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in severity of urinary incontinence between baseline and 24 weeks.
The change in severity of urinary incontinence between baseline and 24 weeks as assessed by the ICIQ-SF will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
baseline and 24 weeks
Secondary Outcomes (29)
The change in severity of urinary incontinence between baseline and week 6, 12, and 18.
baseline, week 6, week 12, week 18
The change in frequency of urinary incontinence between baseline and week 6, 12, 18, and 24.
baseline, week 6, week 12, week 18, week 24
The change in daily urinary leakage volume between baseline and week 6, 12, 18, and 24.
baseline, week 6, week 12, week 18, week 24
The change in stress-induced urinary leakage volume between baseline and week 24.
baseline, week 24
The change in frequency of nocturia between baseline and week 6, 12, 18, and 24.
baseline, week 6, week 12, week 18, week 24
- +24 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORParticipants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Water soluble pollen extract fraction
EXPERIMENTALThe experimental product contains 180mg (360mg/day) of water soluble pollen extract fraction. Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Lipid soluble pollen extract fraction + water soluble pollen extract fraction
EXPERIMENTALThe experimental product is a combination of 9 mg lipid soluble pollen extract fraction (18mg/day) and 180 mg water soluble pollen extract fraction (360mg/day). Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Lipid soluble pollen extract fraction
EXPERIMENTALThe experimental product contains 9mg (18mg/day) of lipid soluble pollen extract fraction. Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Water soluble pollen extract fraction + cranberry powder
EXPERIMENTALThe experimental product is a combination of 42 mg water soluble pollen extract fraction (84 mg/day) and 125 mg cranberry powder (250 mg/day). Participants will be instructed to take one (1) capsule twice daily before breakfast and dinner with a glass of water for 24 weeks beginning on the Day 1, the day after their baseline visit. If a dose is missed participants are instructed to take the missed dose with the next scheduled dose. Participants will be advised not to exceed 3 capsules daily.
Interventions
Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.
Each capsule contains a combination of 9 mg of lipid soluble pollen extract fraction and 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (18 mg/day and 360 mg/day, respectively) for 24 weeks.
Each capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks.
Each capsule contains a combination of 42 mg of water soluble pollen extract and 125 mg of cranberry powder. One capsule will be taken twice daily (84 mg/day and 250 mg/day, respectively) for 24 weeks.
Eligibility Criteria
You may qualify if:
- Females between the ages of 40-75 inclusive.
- BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive.
- Involuntary loss of urine (incontinence) persisting for at least 1 month as determined by a score ≥ 5 on the ICIQ-SF questionnaire at the screening visit.
- Female participant is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation) or have been post-menopausal (natural or surgically) for at least 1 year prior to screening.
- Or,
- Females of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
- Agree to keep lifestyle habits consistent (dietary habits and physical activity patterns) for the duration of the trial.
- Willing to maintain current caffeine intake. Individuals with excessive habitual caffeine intake (\>3 cups coffee or \>4 cups caffeinated tea per day or \>2 energy drinks) will be required to reduce consumption for 2 weeks prior to baseline.
- Healthy as determined by laboratory results, medical history, and physical exam.
- Has given voluntary, written, informed consent to participate in the study.
You may not qualify if:
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
- Allergy or sensitivity to test product ingredients.
- Treatment (ie. pessary) or surgery (ie. sling, mesh) for urinary incontinence from a continence specialist (ie. urologist, urogynecologist, gynecologist) within the past 5 years.
- Treatment for overactive or neurogenic bladder in previous 3 months (ie. neuromodulation, botox).
- Initiation of pelvic floor therapy in the previous 3 months.
- Current utilization of a catheter for urination.
- Current urinary tract infection (UTI, confirmed by laboratory analysis), verbal confirmation of infection in previous 3 months or history of recurrent UTIs.
- Women who are currently taking medications for urinary incontinence/overactive bladder (see Section 6.3.1).
- Irregular menstrual periods within the previous 6 months (less than 21 or greater than 33 days between cycles).
- Women who are within 1-year postpartum.
- Genital malformation (i.e. Vaginal fistula) or vaginal and/or vulvar disorder (i.e. vulvovaginal atrophy).
- Women on hormone replacement therapy (oral or topical), unless on a stable dose for ≥6 months.
- Metal implants that may affect the DXA scan results will be assessed on case-by-case basis by the QI.
- Current, chronic constipation reviewed on a case-by-case basis by the QI.
- Current or history of diabetes.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Graminex LLClead
- KGK Science Inc.collaborator
Study Sites (1)
KGK Science Inc.
London, Ontario, N6A 5R8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Crowley
KGK Science Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2022
First Posted
August 22, 2022
Study Start
June 17, 2019
Primary Completion
October 26, 2021
Study Completion
October 26, 2021
Last Updated
August 22, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share