Clinical TrialID 331
Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
NCT05013593
Urge Incontinence|Overactive Bladder
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 331
- Evidence Id
- 331
- Core Evidence Id
- 331
- Source Clinical Trial Id
- 317
- Herb2 Clinical Trial Id
- HBCT000317
- Nct Id
- NCT05013593
- Title
- Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
- Status
- Completed
- Phase
- Study Result
- No
- Study Condition
- Urge Incontinence|Overactive Bladder
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE
- Intervention
- DIETARY_SUPPLEMENT: Red Clover Extract (RCE)|OTHER: Placebo (PL)
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Basic_Science
- Gender
- Female
- Age
- Adult, Older_Adult
- Enrollment
- 108
- Outcome Measure
- 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
- Sponsor Collaborator
- Vendsyssel Hospital|University of Aarhus
- Funded By
- OTHER_GOV
- Location
- North Denmark Regional Hospital (Vendsyssel Hospital), Hjørring, 9800, Denmark
- Other Id
- N-20190028
- Start Date
- 2019-07-15
- Primary Completion Date
- 2021-10-20
- Completion Date
- 2021-10-20
- First Posted
- 2021-08-19
- Results First Posted
- Last Update Posted
- 2023-04-26
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT05013593
- Title Cn
- Title En
- Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder
- Bilingual Status
- semi_complete