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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
Who can join
Ages 55 and older · Women
Full eligibility criteria
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
About the study
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
What is being tested
- onabotulinum toxin type a (drug)
Sponsor: Alexis Dieter · Participants: 40 · Started: Sep 3, 2025
Contact the study team
Official record on ClinicalTrials.gov — NCT07025044
Locations in the U.S.
| District of Columbia | MedStar Urogynecology Clinic, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.