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

First listed
Jun 17, 2025
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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