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Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics

NCT04090190 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-11-15

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Medical University of Silesia

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Vatche Minassian, MD, MPH · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2021-05-30
Completion
2021-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04090190 on ClinicalTrials.gov