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Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Urinary Incontinence Clinical Trial

Official title:
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Clinical Trial 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 in blood and urine in women with urgency UI. The study will assess how inflammation may affect response to standard of care anticholinergic medication treatment for urgency urinary incontinence.

Clinical Trial 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 anticholinergic medication for six weeks. The patient will be asked to provide a catheterized urine sample at baseline and 6 weeks and blood draw only at baseline. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and fill a bladder diary for 48 hours before starting the anticholinergic medication. The urine will be assessed by standard and enhanced urine cultures and DNA amplification and 16S rRNA sequencing for urinary microbiome along with inflammatory markers in the urine. Inflammatory markers in both the blood and urine will be measured using immunoenzyme assays. Measurements for microbiome will be repeated for all patients at 6 weeks. Baseline urinary symptoms at enrollment and variation of symptoms after 6 weeks of anticholinergic treatment will be assessed using the UDI-6 questionnaire and a bladder diary. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04090190
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Completed
Phase Phase 4
Start date October 30, 2019
Completion date October 31, 2021
View Details
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