Observational Study of Onabotulinum Toxin Type A for Overactive Bladder

This study is looking at women over 55 with overactive bladder (OAB) who are already scheduled to receive Onabotulinum toxin type A injections. Researchers want to understand how the genitourinary (urinary and genital) microbiome (the community of tiny organisms) changes before and after these injections. They will collect urine samples to compare how the microbiome looks before treatment and four weeks after. The main goal is to see if they can successfully recruit participants and work with experts to collect and analyze these samples. This study is observational, meaning you will receive your standard treatment, and researchers will collect information about it. The study aims to enroll 40 participants.

Study design
This is a single-site observational study planning to enroll 40 women. It is not a randomized study, meaning there is no comparison group receiving a different treatment.
What's involved
You will have urine samples collected at the beginning of the study and again four weeks after your Onabotulinum toxin type A injection. You will also complete one self-collection and one clinic-collection at each time point.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately one month after the Onabotulinum toxin type A injection.

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NCT07025044

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

Recruiting
Not specifiedAges 55+Observational
Alexis Dieter
~40 participants
Updated 2025-09-12 on ClinicalTrials.gov
What's tested:onabotulinum toxin type a

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment
Measured over 6 months
Overactive Bladder (OAB)
Urge Incontinence
1 sites across 1 states
District of Columbia1

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Eligibility criteria

Inclusion

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

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
  • Recruitment6 months

    recruitment of 40 eligible subjects from our diverse population of postmenopausal women undergoing BTX for OAB