An interventional study of Red Clover Extract (RCE) and Placebo (PL) in Urge Incontinence and Overactive Bladder, sponsored by Regionshospital Nordjylland. Completed at 1 site in Denmark. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by Regionshospital Nordjylland · Not applicable, Interventional, and Basic science
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
242 studies on the registry are indexed under Urinary Incontinence, Urge; 39 are open to participants now.
This study's enrollment of 108 is above the median of 86 across 190 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →Regionshospital Nordjylland is the lead sponsor of 18 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Dietary Supplement: Red Clover Extract (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)
Dietary Supplement: Red Clover Extract (RCE)
Bladder symptomatic group receiving placebo
Other: Placebo (PL)
Healthy group without bladder symptoms receiving placebo
Other: Placebo (PL)
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)
Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.
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
Time frame: 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
Time frame: 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
Time frame: Baseline
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to three months follow-up
Plan to share: Yes — 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).
Time frame: Data will become available upon article publication at NCBI.
Access criteria: All will have access to the microbiome data
No publications or documents are linked to this record.
Ran from Jul 2019 to primary completion in Oct 2021, 27 months.
Of 47 non-industry interventional studies with no phase under Urinary Incontinence, Urge, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 27 months is above that.
Counting every sponsor, half of 77 studies reached it within 20 months; a quarter within 10 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Regionshospital Nordjylland