Urge IncontinenceNCT05013593
Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
A study testing Red Clover Extract (RCE) in people with Urge Incontinence and Overactive Bladder, run by Regionshospital Nordjylland at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urge Incontinence, Overactive Bladder
- What is being tested?
- Red Clover Extract (RCE)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jul 2019to 20 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal (more than 5 years since last menstruation)
- Read and understand Danish
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Denmark1 site
North Denmark Regional Hospital (Vendsyssel Hospital)
Hjørring, 9800
About this study
Official title: The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women
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
- Conditions
- Urge Incontinence, Overactive Bladder
- Being tested
- Red Clover Extract (RCE), Placebo (PL)
- Keywords
- Microbiota, Microbiome
- Medical subject headings
- Urinary Incontinence, Urge, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
Placebo (PL)Other
Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Dietary Supplement: Red Clover Extract (RCE) |
| 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) Receives: Dietary Supplement: Red Clover Extract (RCE) |
| Symptomatic PL | Placebo comparator | Bladder symptomatic group receiving placebo Receives: Other: Placebo (PL) |
| Healthy PL | Placebo comparator | Healthy group without bladder symptoms receiving placebo Receives: Other: Placebo (PL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Baseline
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start15 Jul 2019
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urge IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded, randomized, placebo-controlled three-month trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospital Nordjylland
- Sponsor type
- Other government
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Annemarie Brusen Villadsen, Regionshospital Nordjylland
- Investigators
- Annemarie B Villadsen, Principal investigator, Regionshospital Nordjylland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013593
- Sponsor's protocol ID
- N-20190028
- Status last verified
- Apr 2023
- First submitted
- 3 Aug 2021
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Red Clover Isoflavones on Urinary Microbiota Composition and Interaction With the Urothelium in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT05013593
- Acronym / sponsor ID
- N-20190028
- Conditions
- Urge Incontinence, Overactive Bladder
- Keywords
- Microbiota, Microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Regionshospital NordjyllandOther government
- Collaborators
- University of Aarhus
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 19 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blinded, randomized, placebo-controlled three-month trial
| Arm | Type | Receives |
|---|---|---|
| Symptomatic RCE | Experimental | Dietary Supplement: Red Clover Extract (RCE)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 | 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) |
| Symptomatic PL | Placebo comparator | Other: Placebo (PL)Bladder symptomatic group receiving placebo |
| Healthy PL | Placebo comparator | Other: Placebo (PL)Healthy group without bladder symptoms receiving placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Postmenopausal (more than 5 years since last menstruation)
- Read and understand Danish
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red Clover Extract (RCE)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) | Dietary supplement | Healthy RCE, Symptomatic RCE |
| Placebo (PL)Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor. | Other | Healthy PL, Symptomatic PL |
Primary outcome
Change from baseline microbiota composition in women suffering from UUI and OAB at three months follow-up
Time frame: From baseline to 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
Change in baseline microbiota composition at three months follow-up
Time frame: From baseline to 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
Difference in baseline microbiota composition between women with and without UUI and OAB
Time frame: Baseline
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
9 secondary outcomes
Comparison of the urinary, vaginal, and fecal microbiota
Time frame: Baseline
Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months 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
Time frame: From baseline to three months follow-up
Change in blood estrogen levels from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Change in blood isoflavone levels from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Change in blood equol levels from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Change in gastrointestinal symptoms from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Change in Irritable Bowel Syndrome Severity Score Scale from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Change in Gastrointestinal Symptom Rating Scale from baseline to three months follow-up
Time frame: From baseline to three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemarie B Villadsen principal investigator
Regionshospital Nordjylland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Red Clover Extract (RCE) in people with Urge Incontinence and Overactive Bladder, run by Regionshospital Nordjylland at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline microbiota composition in women suffering from UUI and OAB at three months follow-up (time frame: From baseline to three months follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.