Clinical Trial

Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections

Study acronym: MICROAB_Pilot
Recruiting
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Record status
This record was last updated September 12, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-09.
Status change: Not Yet Recruiting → Recruiting 2025-09-08
Trial Details
NCT Number NCT07025044
Lead Sponsor Alexis Dieter
Collaborators: Medstar Health Research Institute
Conditions Overactive Bladder (OAB), Urge Incontinence
Enrollment 40 participants
Start Date 2025-09-03
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-12