Status:
COMPLETED
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Medical University of Silesia
Conditions:
Urinary Incontinence
Urgency Urinary
Eligibility:
FEMALE
50+ years
Phase:
PHASE4
Brief Summary
Urinary incontinence (UI) is a very common condition affecting women of all ages. The objective of this pilot study is to better understand the urinary microbiome and associated inflammatory markers i...
Detailed Description
This study is designed as a prospective pilot study of women presenting to the Urogynecology clinic with urgency urinary incontinence symptoms who are offered treatment with a standard of care anticho...
Eligibility Criteria
Inclusion
- Postmenopausal (Age ≥ 50) women with Urgency Urinary Incontinence (UUI)
- English speaking
- Willing to take anticholinergics for at least 6 weeks
- Willing to complete UDI-6 and voiding diary at baseline and 6 weeks
- Willing to give urine and blood for study at baseline and 6 weeks
Exclusion
- Have taken anticholinergic medication within the last month
- Have taken antibiotics within the last month
- Urinary Tract Infection (UTI) in the last three months
- Neurological disease (eg. Parkinson's disease, Multiple Sclerosis, etc.)
- Immunological deficiencies
- History of sexually transmitted disease (STD)
- Lack of consent
- Not ambulatory (e.g. uses a wheelchair)
Key Trial Info
Start Date :
October 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04090190
Start Date
October 30 2019
End Date
October 31 2021
Last Update
November 15 2022
Active Locations (1)
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1
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115