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

Regionshospital Nordjylland108 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

108

Conditions

Urge Incontinence Overactive Bladder

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

North Denmark Regional Hospital (Vendsyssel Hospital)

Hjørring, Denmark

Outcomes

Primary Outcomes

Change from baseline microbiota composition in women suffering from UUI and OAB at 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

Time frame: From baseline to three months follow-up

Change in baseline microbiota composition at 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

Time frame: From baseline to three months follow-up

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

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

Time frame: Baseline

Secondary Outcomes

Comparison of the urinary, vaginal, and fecal microbiota

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

Data from ClinicalTrials.gov

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