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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Alexis Dieter
Study ID
NCT07025044
Status
Recruiting
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Conditions

  • Overactive Bladder (OAB)
  • Urge Incontinence

Eligibility Criteria

Sex
FEMALE
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • onabotulinum toxin type a — DRUG
    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.

Study Details

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

Key Dates

Start date
Sep 3, 2025
Status verified
Sep 2025
Primary completion
Dec 31, 2025
Completion
Jun 1, 2026

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: Women >55yo undergoing onabotulinum toxin type A injection for OAB in clinic

Primary Outcome Measure

Recruitment [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
MedStar Urogynecology ClinicWashington D.C.District of Columbia20010
Moriarty
[email protected]
202-748-4112
[email protected]
Alexis Dieter, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MedStar Urogynecology Clinic· Washington D.C., DC

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