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Recruiting Phase 4 NCT05519072

Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Trial Parameters

Condition Antibiotic Prophylaxis
Sponsor Atlantic Health System
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 140
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-08-16
Completion 2024-08-16
Interventions
Nitrofurantoin

Brief 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.

Eligibility Criteria

Inclusion Criteria: * Female * Age ≥ 18 * Patient undergoing bladder Botox treatment Exclusion Criteria: * Pregnant and/or breastfeeding * Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, symptomatic urinary retention or post void residual (PVR) \> 200 mL, unwillingness or inability to initiate clean intermittent catheterization (CIC) post-treatment if required. * Contraindication to oral antibiotics - hypersensitivity or allergy * Inability to take medication by mouth

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