Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections
Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
Alexis Dieter
40 participants
Sep 3, 2025
OBSERVATIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- Natal female > 55 years old
- English-speaking
- Scheduled to undergo onabotulinum toxin type A for treatment of OAB
- No menses for >1 year if uterus in situ
- Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol
Exclusion Criteria7
- Diagnosis of painful bladder syndrome
- Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure*
- Systemic antibiotic exposure within 30 days\^
- Prophylactic antibiotic treatment for recurrent UTI within the last 12 months
- Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment
- Prior pelvic radiation
- Indwelling catheter or intermittent catheterization
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Interventions
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)
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NCT07025044