NCT04090190

Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Urinary Incontinence
• Urgency Urinary

Interventions

Type	Name	Description
DRUG	Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine	Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.

Timeline

• Start date: 2019-10-30
• Primary completion: 2021-05-30
• Completion: 2021-10-31
• First posted: 2019-09-16
• Last updated: 2022-11-15
• Results posted: 2022-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study