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Completed

NCT Number: NCT05013593

Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder

The purpose of this study is to investigate the effect of red clover isoflavones in postmenopausal women with and without urge urinary incontinence and overactive bladder

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Key information

Conditions

Urge Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

North Denmark Regional Hospital (Vendsyssel Hospital)

Hjørring, 9800, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Postmenopausal (more than 5 years since last menstruation)
  • Read and understand Danish

Exclusion criteria

  • Participants receive treatment with estrogen both oral, transdermal, and topical within three months prior to inclusion in the study
  • Participants take estrogen-like compounds (isoflavones) three months prior to inclusion in the study
  • Participants take prebiotic and/or probiotic supplements within three months prior to study inclusion
  • Receive antibiotics (any) within three months prior to inclusion in the study
  • Recurrent urinary tract infections (defined as ≥ 2 infections in the last six months or ≥ 3 infections during the last year)
  • Acute urinary tract infection defined as positive urine culture and symptoms of acute cystitis
  • Previous or current diseases of the digestive and/or urinary systems evaluated by PI (including, but not limited to inflammatory bowel disease (IBD) and cancer)
  • Current or prior suffering from breast, ovary, and/or endometrial cancer
  • Use hormone spiral within the last 5 years if they are under 60 years
  • Hysterectomy before cessation of menstrual periods if the women are below the age of 60

Treatment and study plan

Red Clover Extract (RCE)

Dietary Supplement

Red clover extract containing isoflavones Formononetin and biochanin A together with a heterogenous culture of probiotic lactic acid bacteria, and a natural sugar free raspberry/orange flavor. Isoflavone amount is 57.45 mg isoflavones daily (55.84 mg aglycones daily), in 70 ml red clover extract (35 ml twice daily, morning and evening together with a meal)

Placebo (PL)

Other

Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.

Primary outcomes

  1. Change from baseline microbiota composition in women suffering from UUI and OAB at three months follow-up

    Time frame: From baseline to three months follow-up

    The microbiota composition is analyzed using sequencing of bacterial DNA. We are investigating the urinary, vaginal and gut microbiota. In women with urge urinary incontinence (UUI) and overactive bladder (OAB) receiving RCE (symptomatic RCE), a possible change in the urinary, vaginal and fecal microbiota composition from baseline to three month follow-up, compared to controls receiving placebo (symptomatic PL) are investigated.

    Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up

  2. Change in baseline microbiota composition at three months follow-up

    Time frame: From baseline to three months follow-up

    The microbiota composition is analyzed using sequencing of bacterial DNA. Comparison of healthy women without bladder symptoms receiving RCE (healthy RCE) at baseline to three months follow-up compared to controls (healthy PL) from baseline to follow-up.

    Healthy RCE from baseline to follow-up vs. Healthy PL from baseline to follow-up

  3. Difference in baseline microbiota composition between women with and without UUI and OAB

    Time frame: Baseline

    The microbiota composition is analyzed using sequencing of bacterial DNA. Is there a difference in the urinary, vaginal and gut microbiota in women with and without urge urinary incontinence (UUI) and overactive bladder (OAB) at baseline?

    Symptomatic PL baseline vs. Healthy PL baseline

Secondary outcomes

  1. Comparison of the urinary, vaginal, and fecal microbiota

    Time frame: Baseline

    The microbiota composition is analyzed using sequencing of bacterial DNA. This composition is evaluated using alpha-diversity (measured based on number of unique bacteria as well as Shannon diversity and phylogenic diversity) and beta-diversity, as indicated by unifrac distance and bray-Curtis dissimilarity. Comparison of the urinary, vaginal, and fecal microbiota composition at baseline. All the different compartments are measured using the same Units of Measure.

    Healthy PL baseline urinary vs. Healthy PL baseline vaginal vs. Healthy PL baseline gut

  2. Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months follow-up

    Time frame: From baseline to three months follow-up

    Overactive bladder symptoms are measured using the questionnaire International Consultation on Incontinence Questionnaire (ICIQ) Overactive Bladder (ICIQ-OAB). Comparison of symptom scores in women with UUI and OAB before and after treatment with RCE compared to placebo.

    Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up

  3. Change in urinary incontinence symptoms from baseline in women suffering from UUI and OAB at three months follow-up

    Time frame: From baseline to three months follow-up

    Urinary incontinence symptoms are measured using the questionnaire International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence Short Form (ICIQ-UI-SF). Comparison of symptom scores in women with UUI and OAB before and after treatment with RCE compared to placebo.

    Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up

  4. Change in blood estrogen levels from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Blood estrogen levels are measured from serum blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment.

  5. Change in blood isoflavone levels from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Blood isoflavone levels are measured in ng/mL from plasma blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment.

  6. Change in blood equol levels from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Blood equol levels are measured in nmol/L from plasma blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment.

  7. Change in gastrointestinal symptoms from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Gastrointestinal symptoms are measured using Rom IV criteria before and after RCE and PL intake.

  8. Change in Irritable Bowel Syndrome Severity Score Scale from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Gastrointestinal symptoms are measured using the Irritable Bowel Syndrome Severity Score Scale before and after RCE and PL intake.

  9. Change in Gastrointestinal Symptom Rating Scale from baseline to three months follow-up

    Time frame: From baseline to three months follow-up

    Gastrointestinal symptoms are measured using the Gastrointestinal Symptom Rating Scale before and after RCE and PL intake.

Sponsors and collaborators

Lead sponsor

Regionshospital Nordjylland

Other Gov

Collaborators

  • University of Aarhus

Registry information

Official study title

The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 19, 2021
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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