Actively Recruiting
Evaluating the Need for Antibiotics Before OnabotulinumtoxinA Injection to Treat Overactive Bladder in Adults Without Urinary Tract Infection
Led by Benaroya Research Institute · Updated on 2024-05-24
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of prophylactic antibiotics before intradetrusor injection of onabotulinumtoxinA in patients with overactive bladder OAB who are not showing symptoms of urinary tract infection UTI. This treatment is FDA approved and used when behavioral and oral medication therapies have not controlled OAB symptoms. Since UTIs are a common side effect of this injection and antibiotics are commonly given beforehand, this study aims to determine if antibiotics are necessary for patients without UTI symptoms and with negative urinalysis, addressing concerns about antibiotic overuse and resistance. The study compares two groups one receiving a single dose of prophylactic antibiotics before the injection, which is the current standard of care, and another receiving no antibiotics prior to the cystoscopic injection of onabotulinumtoxinA. The choice of antibiotic depends on prior urine culture results, allergies, and medical conditions. The trial is randomized and monitors patients for differences in post-procedure symptomatic UTI rates. Participants will be assessed for symptomatic UTI within 14 days after the injection. Secondary measures include improvements in OAB symptoms and rates of side effects like painful urination, bloody urine, and urinary retention over 14 to 30 days. The study involves urine tests, symptom questionnaires, and monitoring for adverse events. The total duration of participation is based on follow-up visits within the first month after treatment to evaluate safety and treatment outcomes.
CONDITIONS
Brief Title
Antibiotic Usage Prior to OnabotulinumtoxinA Injection
Research Team
J
Justina Tam, MD
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