The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence

Graminex LLC

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Dietary Supplement: Water soluble pollen extract fraction + cranberry powder; Dietary Supplement: Lipid soluble pollen extract fraction + water soluble pollen extract fraction; Other: Placebo; Dietary Supplement: Lipid soluble pollen extract fraction; Dietary Supplement: Water soluble pollen extract fraction

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05510999

19GUHG

Details and patient eligibility

About

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).

Enrollment: 190 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Females between the ages of 40-75 inclusive.

2. BMI 18.5 kg/m2 - 34.9 kg/m2 inclusive.

3. 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.

4. 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

5. Agree to keep lifestyle habits consistent (dietary habits and physical activity patterns) for the duration of the trial.

6. 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.

7. Healthy as determined by laboratory results, medical history, and physical exam.

8. Has given voluntary, written, informed consent to participate in the study.

Exclusion criteria

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
2. Allergy or sensitivity to test product ingredients.
3. Treatment (ie. pessary) or surgery (ie. sling, mesh) for urinary incontinence from a continence specialist (ie. urologist, urogynecologist, gynecologist) within the past 5 years.
4. Treatment for overactive or neurogenic bladder in previous 3 months (ie. neuromodulation, botox).
5. Initiation of pelvic floor therapy in the previous 3 months.
6. Current utilization of a catheter for urination.
7. Current urinary tract infection (UTI, confirmed by laboratory analysis), verbal confirmation of infection in previous 3 months or history of recurrent UTIs.
8. Women who are currently taking medications for urinary incontinence/overactive bladder (see Section 6.3.1).
9. Irregular menstrual periods within the previous 6 months (less than 21 or greater than 33 days between cycles).
10. Women who are within 1-year postpartum.
11. Genital malformation (i.e. Vaginal fistula) or vaginal and/or vulvar disorder (i.e. vulvovaginal atrophy).
12. Women on hormone replacement therapy (oral or topical), unless on a stable dose for ≥6 months.
13. Metal implants that may affect the DXA scan results will be assessed on case-by-case basis by the QI.
14. Current, chronic constipation reviewed on a case-by-case basis by the QI.
15. Current or history of diabetes.
16. Current or history of bladder tumour.
17. Current sexually transmitted infection (confirmed by laboratory analysis), or verbal confirmation of infection in previous 3 months.
18. Current or history of liver, kidney or heart disease.
19. 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 .
20. Current or history of bleeding disorders.
21. Clinically significant abnormal laboratory results at screening.
22. Excessive consumption of alcohol equivalent to >2 alcoholic drinks/day (average).
23. Alcohol or drug abuse within the last 6 months.
24. Individuals who are cognitively impaired and/or who are unable to give informed consent.
25. Any autoimmune disease or immune-compromised (i.e. HIV positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C positive).
26. Participation in other clinical research trials one month prior to or during enrollment will be assessed case-by-case by the QI.
27. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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190 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Water soluble pollen extract fraction

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Water soluble pollen extract fraction

Lipid soluble pollen extract fraction + water soluble pollen extract fraction

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipid soluble pollen extract fraction + water soluble pollen extract fraction

Lipid soluble pollen extract fraction

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lipid soluble pollen extract fraction

Water soluble pollen extract fraction + cranberry powder

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Water soluble pollen extract fraction + cranberry powder