CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04090190
NCT04090190Phase 4Completed

Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

Brigham and Women's Hospital·interventional·Posted Sep 16, 2019·Updated Nov 15, 2022

In Brief

A Phase 4 clinical trial evaluating Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodine for Urinary Incontinence and Urgency Urinary. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedSep 16, 2019
Enrollment StartOct 30, 2019
Primary CompletionMay 30, 2021
Study CompletionOct 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.8 years ago

Interventions

Oxybutynin, Solifenacin, Tolterodine, Trospium, or Fesoterodinedrug

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.