Recruitment

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