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

Launched by ALEXIS DIETER · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying women with overactive bladder (OAB), a condition where you feel a sudden, strong need to urinate and may sometimes leak urine (urge incontinence). The study focuses on how the community of bacteria and other tiny organisms in the urinary tract (called the genitourinary microbiome) might change before and after treatment with injections of onabotulinum toxin type A (a medicine often known as Botox) into the bladder muscle. Researchers want to learn more about how this treatment affects these bacteria and to see if it influences the risk of urinary tract infections or other side effects like difficulty emptying the bladder.

Women who are 55 years or older, speak English, have gone through menopause (no menstrual periods for at least a year), and are scheduled to receive this Botox treatment for OAB might be eligible to join. Participants will provide urine samples before and about four weeks after the injection, some collected by themselves at home and some collected at the clinic, so researchers can compare the results. They will also track how well the treatment works and whether any infections or bladder-emptying problems occur during the first month after treatment. This study is still not recruiting participants yet but is designed to help improve understanding of OAB treatment and its effects on bladder health.

Gender

FEMALE

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