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

Vendsyssel Hospital

Status: Completed

Conditions: Overactive Bladder; Urge Incontinence

Treatments: Other: Placebo (PL); Dietary Supplement: Red Clover Extract (RCE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05013593

N-20190028

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 4 patient groups, including a placebo group

Symptomatic RCE

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Red Clover Extract (RCE)

Healthy RCE

Experimental group

Description:

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)

Treatment:

Dietary Supplement: Red Clover Extract (RCE)

Symptomatic PL

Placebo Comparator group

Description:

Bladder symptomatic group receiving placebo

Treatment:

Other: Placebo (PL)

Healthy PL

Placebo Comparator group

Description:

Healthy group without bladder symptoms receiving placebo

Treatment:

Other: Placebo (PL)