Red Clover Isoflavones in Postmenopausal Women With Urge Urinary Incontinence and Overactive Bladder

NCT05013593 | Completed

• 1 other identifier: N-20190028
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Conditions

Urge Incontinence; Overactive Bladder

Keywords

Microbiota; Microbiome

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (9)

• Comparison of the urinary, vaginal, and fecal microbiota

  Baseline

• Change in overactive bladder symptoms from baseline in women suffering from UUI and OAB at three months 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

  From baseline to three months follow-up

• Change in blood estrogen levels from baseline to three months follow-up

  From baseline to three months follow-up

• Change in blood isoflavone levels from baseline to three months follow-up

  From baseline to three months follow-up

Study Arms (4)

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)

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)

Dietary Supplement: Red Clover Extract (RCE)

Symptomatic PL

PLACEBO COMPARATOR

Bladder symptomatic group receiving placebo

Other: Placebo (PL)

Healthy PL

PLACEBO COMPARATOR

Healthy group without bladder symptoms receiving placebo

Other: Placebo (PL)

Interventions

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)

Healthy RCE; Symptomatic RCE

Placebo (PL) OTHER

Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.

Healthy PL; Symptomatic PL

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal (more than 5 years since last menstruation)
• Read and understand Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Regionshospital Nordjylland: lead
• University of Aarhus: collaborator

Study Sites (1)

North Denmark Regional Hospital (Vendsyssel Hospital)

Hjørring, 9800, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Bladder Diseases

Study Officials

• Annemarie B Villadsen

  Regionshospital Nordjylland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. student

Model Details: Double-blinded, randomized, placebo-controlled three-month trial

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 19, 2021
• Study Start: July 15, 2019
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available upon article publication at NCBI.
• Access Criteria: All will have access to the microbiome data

Locations

DK (1)