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Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections
Sponsor: Alexis Dieter
Summary
Single-site prospective observational pilot feasibility study of women with overactive bladder/urge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives: * Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland * Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics * Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples * Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX
Official title: Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
Key Details
Gender
FEMALE
Age Range
55 Years - Any
Study Type
OBSERVATIONAL
Enrollment
40
Start Date
2025-09-03
Completion Date
2026-06-01
Last Updated
2025-09-12
Healthy Volunteers
No
Interventions
onabotulinum toxin type a
All subjects will be scheduled to undergo Onabotulinum toxin type A intradetrusor injection for management of OAB. On Day 0, subjects will undergo Onabotulinum toxin type A injection by a licensed clinical provider and receive a one-time dose of Nitrofurantoin for infection prevention per standard clinic protocol.
Locations (1)
MedStar Urogynecology Clinic
Washington D.C., District of Columbia, United States