Genitourinary microbiome before and after Botox bladder injections in postmenopausal women
Official title: Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial
Run by Medstar Health Research Institute · NCT07025044 · Data updated 2026-11-12
We're trying to see if the bacteria in the urine change in postmenopausal women with overactive bladder before and four weeks after Botox bladder injections.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 55 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Medstar Health Research Institute Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, prednisone |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | September 3, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | June 1, 2026 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07025044 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
English-speaking postmenopausal natal females older than 55 who are scheduled to receive onabotulinum toxin A for OAB, have had no recent systemic antibiotics or symptomatic UTI, and can attend baseline and four-week visits are ideal candidates.
✕Probably not a fit
Patients with painful bladder syndrome, recent systemic antibiotic exposure or symptomatic UTI, ongoing immunosuppression, indwelling or intermittent catheterization, prior pelvic radiation, or prophylactic antibiotic use for recurrent UTI are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-site prospective observational pilot enrolling 40 English-speaking postmenopausal natal females over 55 who are scheduled for onabotulinum toxin A intradetrusor injection for OAB. Participants provide one self-collected and one clinic-collected voided urine sample at baseline and again four weeks after the injection, with samples processed for genitourinary microbiome analysis. Clinical data including prior BTX history, BTX dose, receipt of a one-time nitrofurantoin prophylaxis per clinic protocol, and events such as UTI or incomplete voiding requiring catheterization are recorded. The study compares microbiome composition pre- and post-injection and compares self-collected versus clinic-collected specimens to test feasibility and generate pilot data.
Why it matters
Potential benefit: If successful, this could identify microbiome patterns linked to response or infection risk after Botox and help guide prevention or monitoring strategies.
How similar studies have gone: Prior studies have linked urinary microbiome patterns to OAB and UTI risk, but using pre/post comparisons around Botox injections and direct self-versus-clinic collection comparisons is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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MedStar Urogynecology Clinic
Washington D.C., District of Columbia, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.