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

Recruitingn/aAges 55 Years - anyFemaleAlexis Dieter
NCT07025044 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • onabotulinum toxin type a
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Where

1 site
MedStar Urogynecology Clinic
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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