Clinical trial NCT05013593: Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
Official title: The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urge Incontinence
Overactive Bladder
Keywords: Microbiota
Microbiome
Lead sponsor: Regionshospital Nordjylland
Sponsor class: OTHER_GOV
Collaborators: name: University of Aarhus
First posted: 2021-08-19
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, randomized, placebo-controlled three-month trial
Primary purpose: BASIC_SCIENCE

Brief 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


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline microbiota composition in women suffering from UUI and OAB at three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in baseline microbiota composition at three months follow-up
timeFrame: From baseline to three months follow-up
measure: Difference in baseline microbiota composition between women with and without UUI and OAB
timeFrame: Baseline
Secondary outcomes:
measure: Comparison of the urinary, vaginal, and fecal microbiota
timeFrame: Baseline
measure: Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in urinary incontinence symptoms from baseline in women suffering from UUI and OAB at three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in blood estrogen levels from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in blood isoflavone levels from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in blood equol levels from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in gastrointestinal symptoms from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in Irritable Bowel Syndrome Severity Score Scale from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
measure: Change in Gastrointestinal Symptom Rating Scale from baseline to three months follow-up
timeFrame: From baseline to three months follow-up
Other outcomes:
Locations:
city: Hjørring
country: Denmark
facility: North Denmark Regional Hospital (Vendsyssel Hospital)
Study officials:
affiliation: Regionshospital Nordjylland
name: Annemarie B Villadsen
role: PRINCIPAL_INVESTIGATOR
References: