Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Urgency Urinary
- Urinary Incontinence
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 50 years and 125 years
- Gender
- Only males
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 clean catch urine sample a...
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 clean catch urine sample and blood draw. Study participants will fill out a Urinary Distress Inventory-6 (UDI-6) questionnaire at baseline and keep a bladder diary before starting the anticholinergic medication. The urine will be assessed by enhanced urine cultures and DNA sequencing for urinary microbiome along with inflammatory mediators in the urine. Inflammatory mediators in both the blood and urine will be measured using immuonenzyme 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.
Tracking Information
- NCT #
- NCT04090190
- Collaborators
- Medical University of Silesia
- Investigators
- Not Provided