Urinary IncontinencePhase 2NCT05510999
The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
A Phase 2 study testing Water soluble pollen extract fraction, Lipid soluble pollen extract fraction + water soluble pollen extract fraction and Lipid soluble pollen extract fraction in people with Urinary Incontinence, run by Graminex LLC at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Water soluble pollen extract fraction, Lipid soluble pollen extract fraction + water soluble pollen extract fraction and Lipid soluble pollen extract fraction
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2019to 26 Oct 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
Show all 27Show fewer
- 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.
- Current or history of bladder tumour.
- Current sexually transmitted infection (confirmed by laboratory analysis), or verbal confirmation of infection in previous 3 months.
- Current or history of liver, kidney or heart disease.
- Current or pre-existing unstable thyroid condition. Treatment on a stable dose of medication for over one year will be reviewed on a case-by-case basis by the QI .
- Current or history of bleeding disorders.
- Clinically significant abnormal laboratory results at screening.
- Excessive consumption of alcohol equivalent to >2 alcoholic drinks/day (average).
- Alcohol or drug abuse within the last 6 months.
- Individuals who are cognitively impaired and/or who are unable to give informed consent.
- Any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive).
- Participation in other clinical research trials one month prior to or during enrollment will be assessed case-by-case by the QI.
- Any other condition, that, in the opinion of the QI, may adversely affect the participant's ability to provide written informed consent and complete the study or its measures, or pose significant risk to the participant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence.
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).
- Conditions
- Urinary Incontinence
- Being tested
- Placebo, Water soluble pollen extract fraction, Lipid soluble pollen extract fraction + water soluble pollen extract fraction, Lipid soluble pollen extract fraction, Water soluble pollen extract fraction + cranberry powder
- Keywords
- Safety and efficacy, Urinary incontinence, Urinary leakage
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
One capsule of placebo will be taken twice daily for 24 weeks.
Water soluble pollen extract fractionDietary supplement
Each capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks.
Lipid soluble pollen extract fraction + water soluble pollen extract fractionDietary supplement
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.
Lipid soluble pollen extract fractionDietary supplement
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.
Water soluble pollen extract fraction + cranberry powderDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
| Water soluble pollen extract fraction | Experimental | The 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. Receives: Dietary Supplement: Water soluble pollen extract fraction |
| Lipid soluble pollen extract fraction + water soluble pollen extract fraction | Experimental | The 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. Receives: Dietary Supplement: Lipid soluble pollen extract fraction + water soluble pollen extract fraction |
| Lipid soluble pollen extract fraction | Experimental | The 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. Receives: Dietary Supplement: Lipid soluble pollen extract fraction |
| Water soluble pollen extract fraction + cranberry powder | Experimental | The 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. Receives: Dietary Supplement: Water soluble pollen extract fraction + cranberry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 24 weeks
Secondary outcomes (29)
The change in severity of urinary incontinence between baseline and week 6, 12, and 18.
The change in severity of urinary incontinence between baseline and week 6, 12, and 18 as assessed by the ICIQ-SF will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18
The change in frequency of urinary incontinence between baseline and week 6, 12, 18, and 24.
The change in frequency of urinary incontinence between baseline and week 6, 12, 18, and 24 as assessed by void diary will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: 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.
The change in daily urinary leakage volume between baseline and week 6, 12, 18, and 24 as assessed by 24-hour pad weight will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in stress-induced urinary leakage volume between baseline and week 24.
The change in stress-induced urinary leakage volume between baseline and week 24 as assessed by pad weight following a provocative maneuvers challenge will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 24
The change in frequency of nocturia between baseline and week 6, 12, 18, and 24.
The change in frequency of nocturia between baseline and week 6, 12, 18, and 24 as assessed by void diary will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in frequency of daytime urination between baseline and week 6, 12, 18, and 24.
The change in frequency of daytime urination between baseline and week 6, 12, 18, and 24 as assessed by void diary will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in bone density between baseline and week 24.
The change in frequency of bone density between baseline and week 24 as assessed by DXA scan will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 24
The change in incontinence-related quality of life between baseline and weeks 6, 12, 18, and 24.
The change in incontinence-related quality of life between baseline and weeks 6, 12, 18, and 24 as assessed by I-QoL will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in degree of bother between baseline and weeks 6, 12, 18, and 24.
The change in degree of bother between baseline and weeks 6, 12, 18, and 24 as assessed by OAB-q will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in sleep quality between baseline and weeks 6, 12, 18, and 24.
The change in sleep quality between baseline and weeks 6, 12, 18, and 24 as assessed by Sleep Index will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The change in Lower Urinary Tract Symptom Score (LUTSS) between baseline and weeks 6, 12, 18, and 24.
The change in Lower Urinary Tract Symptom Score (LUTSS) between baseline and weeks 6, 12, 18, and 24 as assessed by the LUTSS Questionnaire will be compared between groups assigned to the Graminex® Flower Pollen Extracts and placebo.
Measured: baseline, week 6, week 12, week 18, week 24
The incidence of pre-emergent and post-emergent adverse events during a 24-week supplementation period.
Measured: 24 weeks
Vital sign measurements (blood pressure; BP) during a 24-week supplementation period.
Measured: baseline, week 6, week 12, week 18, week 24
Vital sign measurements (heart rate; HR) during a 24-week supplementation period.
Measured: baseline, week 6, week 12, week 18, week 24
Aspartate aminotransferase (AST) measurement following a 24-week supplementation.
Clinical chemistry (including aspartate aminotransferase (AST)) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Alanine aminotransferase (ALT) measurement following a 24-week supplementation.
Clinical chemistry (including alanine aminotransferase (ALT)) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Bilirubin measurement following a 24-week supplementation.
Clinical chemistry (including bilirubin) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Creatinine measurement following a 24-week supplementation.
Clinical chemistry (including creatinine) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Measurement of electrolytes following a 24-week supplementation.
Clinical chemistry (including electrolytes (Na, K, Cl,)) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Estimated glomerular filtration rate (eGFR) measurements following a 24-week supplementation.
Clinical chemistry (including estimated glomerular filtration rate (eGFR)) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
White blood cell measurements following a 24-week supplementation.
Hematology measurements (including white blood cell count with differential (neutrophils, lymphocytes, monocytes, eosinophils, basophils) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Red blood cell measurements following a 24-week supplementation.
Hematology measurements (including red blood cell count) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Hemoglobin measurements following a 24-week supplementation.
Hematology measurements (including hemoglobin) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Hematocrit measurements following a 24-week supplementation.
Hematology measurements (including hematocrit) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Platelet count measurements following a 24-week supplementation.
Hematology measurements (including platelet count) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Mean corpuscular hemoglobin following a 24-week supplementation.
Red blood cell indices (including mean corpuscular hemoglobin) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Mean corpuscular hemoglobin concentration following a 24-week supplementation.
Red blood cell indices (including mean corpuscular hemoglobin concentration) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Mean corpuscular volume following a 24-week supplementation.
Red blood cell indices (including mean corpuscular volume) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Red cell distribution width following a 24-week supplementation.
Red blood cell indices (including red cell distribution width) will be measured in blood from study participants at 24 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start17 Jun 2019
- Primary completion26 Oct 2021
- Study completion26 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graminex LLC
- Sponsor type
- University, hospital or other
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510999
- Sponsor's protocol ID
- 19GUHG
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence.
- ClinicalTrials.gov ID
- NCT05510999
- Acronym / sponsor ID
- 19GUHG
- Conditions
- Urinary Incontinence
- Keywords
- Safety and efficacy, Urinary incontinence, Urinary leakage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Graminex LLCUniversity, hospital or other
- Collaborators
- KGK Science Inc.
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 26 Oct 2021 (actual)
- Study completion
- 26 Oct 2021 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants 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 | Experimental | Dietary Supplement: Water soluble pollen extract fractionThe 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 | Experimental | Dietary Supplement: Lipid soluble pollen extract fraction + water soluble pollen extract fractionThe 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 | Experimental | Dietary Supplement: Lipid soluble pollen extract fractionThe 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 | Experimental | Dietary Supplement: Water soluble pollen extract fraction + cranberry powderThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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,
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboOne capsule of placebo will be taken twice daily for 24 weeks. | Other | Placebo |
| Water soluble pollen extract fractionEach capsule contains 180 mg of water soluble pollen extract fraction. One capsule will be taken twice daily (360 mg/day) for 24 weeks. | Dietary supplement | Water soluble pollen extract fraction |
| Lipid soluble pollen extract fraction + water soluble pollen extract fractionEach 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. | Dietary supplement | Lipid soluble pollen extract fraction + water soluble pollen extract fraction |
| Lipid soluble pollen extract fractionEach capsule contains 9 mg of lipid soluble pollen extract fraction. One capsule of will be taken twice daily (18 mg/day) for 24 weeks. | Dietary supplement | Lipid soluble pollen extract fraction |
| Water soluble pollen extract fraction + cranberry powderEach 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. | Dietary supplement | Water soluble pollen extract fraction + cranberry powder |
Primary outcome
The change in severity of urinary incontinence between baseline and 24 weeks.
Time frame: 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.
29 secondary outcomes
The change in severity of urinary incontinence between baseline and week 6, 12, and 18.
Time frame: baseline, week 6, week 12, week 18
The change in frequency of urinary incontinence between baseline and week 6, 12, 18, and 24.
Time frame: 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.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in stress-induced urinary leakage volume between baseline and week 24.
Time frame: baseline, week 24
The change in frequency of nocturia between baseline and week 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in frequency of daytime urination between baseline and week 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in bone density between baseline and week 24.
Time frame: baseline, week 24
The change in incontinence-related quality of life between baseline and weeks 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in degree of bother between baseline and weeks 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in sleep quality between baseline and weeks 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The change in Lower Urinary Tract Symptom Score (LUTSS) between baseline and weeks 6, 12, 18, and 24.
Time frame: baseline, week 6, week 12, week 18, week 24
The incidence of pre-emergent and post-emergent adverse events during a 24-week supplementation period.
Time frame: 24 weeks
Vital sign measurements (blood pressure; BP) during a 24-week supplementation period.
Time frame: baseline, week 6, week 12, week 18, week 24
Vital sign measurements (heart rate; HR) during a 24-week supplementation period.
Time frame: baseline, week 6, week 12, week 18, week 24
Aspartate aminotransferase (AST) measurement following a 24-week supplementation.
Time frame: 24 weeks
Alanine aminotransferase (ALT) measurement following a 24-week supplementation.
Time frame: 24 weeks
Bilirubin measurement following a 24-week supplementation.
Time frame: 24 weeks
Creatinine measurement following a 24-week supplementation.
Time frame: 24 weeks
Measurement of electrolytes following a 24-week supplementation.
Time frame: 24 weeks
Estimated glomerular filtration rate (eGFR) measurements following a 24-week supplementation.
Time frame: 24 weeks
White blood cell measurements following a 24-week supplementation.
Time frame: 24 weeks
Red blood cell measurements following a 24-week supplementation.
Time frame: 24 weeks
Hemoglobin measurements following a 24-week supplementation.
Time frame: 24 weeks
Hematocrit measurements following a 24-week supplementation.
Time frame: 24 weeks
Platelet count measurements following a 24-week supplementation.
Time frame: 24 weeks
Mean corpuscular hemoglobin following a 24-week supplementation.
Time frame: 24 weeks
Mean corpuscular hemoglobin concentration following a 24-week supplementation.
Time frame: 24 weeks
Mean corpuscular volume following a 24-week supplementation.
Time frame: 24 weeks
Red cell distribution width following a 24-week supplementation.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Water soluble pollen extract fraction, Lipid soluble pollen extract fraction + water soluble pollen extract fraction and Lipid soluble pollen extract fraction in people with Urinary Incontinence, run by Graminex LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in severity of urinary incontinence between baseline and 24 weeks. (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2022.