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Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Re-verified, no change to tracked fieldsv3
  2. Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 4 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05519072
Lead Sponsor Atlantic Health System
Collaborators: Columbia University
Conditions
(from sponsor)		 Antibiotic Prophylaxis
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov