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

  • STATUS
    Recruiting
  • days left to enroll
    58
  • participants needed
    200
  • sponsor
    Vendsyssel Hospital
Updated on 29 August 2021
incontinence
overactive bladder

Summary

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

Details
Condition Bladder Disorders, Urge Incontinence, Overactive Bladder, Urinary Incontinence, bladder disorder
Treatment Red Clover Extract (RCE), Placebo (PL)
Clinical Study IdentifierNCT05013593
SponsorVendsyssel Hospital
Last Modified on29 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Postmenopausal (more than 5 years since last menstruation)
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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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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