Clinical Trial

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Recruiting Phase 4
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Record status
This record was last updated March 27, 2024 (before its estimated August 16, 2024 completion). Its status may not reflect the trial's current state.
Summary
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance. Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-08-25; most recent amendment 2025-09-30.
Status change: Recruiting → Completed 2025-04-09
Trial Details
NCT Number NCT05519072
Lead Sponsor Atlantic Health System
Collaborators: Columbia University
Conditions Antibiotic Prophylaxis
Enrollment 140 participants
Start Date 2022-08-16
Primary Completion 2024-08-16 (estimated)
Study Completion 2024-08-16 (estimated)
Updated on ClinicalTrials.gov 2024-03-27