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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-15

Study Completion Date

2021-10-20

Brief Summary

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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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Detailed Description

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Conditions

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Urge Incontinence Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, randomized, placebo-controlled three-month trial

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Symptomatic RCE

Bladder symptomatic group receiving red clover extract containing the two isoflavones formononetin and biochanin A. 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 with a meal)

Group Type EXPERIMENTAL

Red Clover Extract (RCE)

Intervention Type 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)

Healthy RCE

Healthy group without bladder symptoms receiving red clover extract containing the two isoflavones formononetin and biochanin A. 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 with a meal)

Group Type EXPERIMENTAL

Red Clover Extract (RCE)

Intervention Type 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)

Symptomatic PL

Bladder symptomatic group receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo (PL)

Intervention Type OTHER

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

Healthy PL

Healthy group without bladder symptoms receiving placebo

Group Type PLACEBO_COMPARATOR

Placebo (PL)

Intervention Type OTHER

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

Interventions

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Red Clover Extract (RCE)

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)

Intervention Type DIETARY_SUPPLEMENT

Placebo (PL)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes