Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial

What this Trial Is About

Researchers are studying postmenopausal women over 55 years old with overactive bladder (OAB) or urge urinary incontinence who are undergoing onabotulinum toxin type A (BTX) injections. This pilot observational study aims to explore the female genitourinary microbiome before and after BTX treatment, assess treatment response, and examine risks such as urinary tract infections and incomplete bladder emptying requiring catheterization. The study also aims to establish collaboration with experts in the female microbiome and test recruitment from a diverse patient population. Participants will receive a single intradetrusor injection of onabotulinum toxin type A by a licensed clinician on Day 0. They will also receive a one-time oral dose of nitrofurantoin for infection prevention unless contraindicated or if at high risk for urinary tract infections. Urine samples will be collected both by the participant and in clinic at baseline and 4 weeks after injection, totaling four collections. The study includes baseline and follow-up questionnaires and patient-reported outcome measures to evaluate treatment effects and safety. The study involves about 40 women who will be followed for approximately one month after their BTX injection. Participants will provide urine specimens at two time points and complete questionnaires at baseline and 4 weeks. Researchers will compare microbiome samples from self-collection versus clinic collection methods and monitor for urinary tract infection rates and adverse events. Participants receive reimbursement for parking and a payment upon completing follow-up activities. The main outcome measured is recruitment success over 6 months, with secondary outcomes including sample collection, treatment response, and adverse events at 4 weeks.

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