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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptomatic RCE | Experimental | 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) |
|
| Healthy RCE | Experimental | 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) |
|
| Symptomatic PL | Placebo Comparator | Bladder symptomatic group receiving placebo |
|
| Healthy PL | Placebo Comparator | Healthy group without bladder symptoms receiving placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annemarie B Villadsen | Regionshospital Nordjylland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Denmark Regional Hospital (Vendsyssel Hospital) | Hjørring | 9800 | Denmark |
Individual deidentified participant data will be shared upon article publication. Microbiome data (DNA sequences) will be uploaded to the Sequence Read Archive (SRA) at the National Center for Biotechnology Information (NCBI).
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Data will become available upon article publication at NCBI.
All will have access to the microbiome data
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| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Double-blinded, randomized, placebo-controlled three-month trial
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| Placebo (PL) | Other | Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor. |
|
| Baseline |
| Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months follow-up | Overactive bladder symptoms are measured using the questionnaire International Consultation on Incontinence Questionnaire (ICIQ) Overactive Bladder (ICIQ-OAB). Comparison of symptom scores in women with UUI and OAB before and after treatment with RCE compared to placebo. Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up | From baseline to three months follow-up |
| Change in urinary incontinence symptoms from baseline in women suffering from UUI and OAB at three months follow-up | Urinary incontinence symptoms are measured using the questionnaire International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence Short Form (ICIQ-UI-SF). Comparison of symptom scores in women with UUI and OAB before and after treatment with RCE compared to placebo. Symptomatic RCE from baseline to follow-up vs. Symptomatic PL from baseline to follow-up | From baseline to three months follow-up |
| Change in blood estrogen levels from baseline to three months follow-up | Blood estrogen levels are measured from serum blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment. | From baseline to three months follow-up |
| Change in blood isoflavone levels from baseline to three months follow-up | Blood isoflavone levels are measured in ng/mL from plasma blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment. | From baseline to three months follow-up |
| Change in blood equol levels from baseline to three months follow-up | Blood equol levels are measured in nmol/L from plasma blood samples. Blood samples are taken at baseline before RCE and PL intake and after three months treatment. | From baseline to three months follow-up |
| Change in gastrointestinal symptoms from baseline to three months follow-up | Gastrointestinal symptoms are measured using Rom IV criteria before and after RCE and PL intake. | From baseline to three months follow-up |
| Change in Irritable Bowel Syndrome Severity Score Scale from baseline to three months follow-up | Gastrointestinal symptoms are measured using the Irritable Bowel Syndrome Severity Score Scale before and after RCE and PL intake. | From baseline to three months follow-up |
| Change in Gastrointestinal Symptom Rating Scale from baseline to three months follow-up | Gastrointestinal symptoms are measured using the Gastrointestinal Symptom Rating Scale before and after RCE and PL intake. | From baseline to three months follow-up |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001745 | Urinary Bladder Diseases |