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

Study acronym: MICROAB_Pilot
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 31, 2025 to Dec 31, 2025
    • Study completion date: Jan 1, 2026 to Jun 1, 2026
    • Start date changed from estimate of Jun 23, 2025 to Sep 3, 2025
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07025044
Lead Sponsor Alexis Dieter
Collaborators: Medstar Health Research Institute
Conditions
(from sponsor)		 Overactive Bladder (OAB), Urge Incontinence
Related terms Urinary Bladder, Overactive, Urinary Incontinence, Urge
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov