Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Abstract
The goal of this clinical trial is to evaluate the outcomes of differing durations of antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory overactive bladder.
The main question it aims to answer are:
• Is the incidence of post-procedure UTI similar between single-dose and multi-day durations of peri-procedural antibiotics?
Participants will be randomized to single-dose versus multi-day dose of antibiotic prophylaxis with bladder onabotulinumtoxinA injection.
Researchers will compare incidence of UTI in each group to see if there is a significant difference.
Conditions: Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Urge.
Primary outcome: Establish Noninferiority of the Single Dose Antibiotic Administration to the Multi-dose Antibiotic Administration..
Enrollment: 100 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 100 participants or records.
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