Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAtlantic Health System

About this trial

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

Qualifiers

Female

Age ≥ 18

Patient undergoing bladder Botox treatment

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Nitrofurantoin

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Atlantic Health System

Lead sponsor

Columbia University

Collaborator