drugset / Trial / NCT05719285

Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection

NCT05719285

Phase 4 Completed 100 enrolled The Cleveland Clinic
RandomizedParallel-groupOpen-labelPrevention

Summary

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.

Timeline

Start
2022-12-06
Primary completion
2023-06-08
Completion
2023-06-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator CEPHALEXIN ANHYDROUS Small molecule 500 mg
Comparator Ciprofloxacin Small molecule 500 mg
Comparator Nitrofurantoin Unknown 100 mg
Comparator Sulfamethoxazole Small molecule 160 mg
Comparator Trimethoprim Small molecule 800 mg

Indications