Clinical trial NCT05510999: The Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence
Official title: A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Efficacy of Graminex® Flower Pollen Extracts in Healthy Women With Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: Safety and efficacy
Urinary incontinence
Urinary leakage
Lead sponsor: Graminex LLC
Sponsor class: OTHER
Collaborators: name: KGK Science Inc.
First posted: 2022-08-22
Enrollment: 190
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: The change in severity of urinary incontinence between baseline and 24 weeks.
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: The change in severity of urinary incontinence between baseline and week 6, 12, and 18.
timeFrame: baseline, week 6, week 12, week 18
measure: The change in frequency of urinary incontinence between baseline and week 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in daily urinary leakage volume between baseline and week 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in stress-induced urinary leakage volume between baseline and week 24.
timeFrame: baseline, week 24
measure: The change in frequency of nocturia between baseline and week 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in frequency of daytime urination between baseline and week 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in bone density between baseline and week 24.
timeFrame: baseline, week 24
measure: The change in incontinence-related quality of life between baseline and weeks 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in degree of bother between baseline and weeks 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in sleep quality between baseline and weeks 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The change in Lower Urinary Tract Symptom Score (LUTSS) between baseline and weeks 6, 12, 18, and 24.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: The incidence of pre-emergent and post-emergent adverse events during a 24-week supplementation period.
timeFrame: 24 weeks
measure: Vital sign measurements (blood pressure; BP) during a 24-week supplementation period.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: Vital sign measurements (heart rate; HR) during a 24-week supplementation period.
timeFrame: baseline, week 6, week 12, week 18, week 24
measure: Aspartate aminotransferase (AST) measurement following a 24-week supplementation.
timeFrame: 24 weeks
measure: Alanine aminotransferase (ALT) measurement following a 24-week supplementation.
timeFrame: 24 weeks
measure: Bilirubin measurement following a 24-week supplementation.
timeFrame: 24 weeks
measure: Creatinine measurement following a 24-week supplementation.
timeFrame: 24 weeks
measure: Measurement of electrolytes following a 24-week supplementation.
timeFrame: 24 weeks
measure: Estimated glomerular filtration rate (eGFR) measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: White blood cell measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: Red blood cell measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: Hemoglobin measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: Hematocrit measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: Platelet count measurements following a 24-week supplementation.
timeFrame: 24 weeks
measure: Mean corpuscular hemoglobin following a 24-week supplementation.
timeFrame: 24 weeks
measure: Mean corpuscular hemoglobin concentration following a 24-week supplementation.
timeFrame: 24 weeks
measure: Mean corpuscular volume following a 24-week supplementation.
timeFrame: 24 weeks
measure: Red cell distribution width following a 24-week supplementation.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: KGK Science Inc.
name: David Crowley
role: PRINCIPAL_INVESTIGATOR
References: