Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA

• Status: Recruiting
• Trial end date: 2024-08-16
• Target enrollment: 0
• Participant gender: Female

Summary

Our 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, we 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. Patients will return for a follow up appointment approximately 2 weeks after treatment to assess for UTI symptoms. They will be called again at 6 weeks for follow up.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Atlantic Health System
• Collaborator: Columbia University
• Treatments: Amoxicillin-Potassium Clavulanate Combination; Cephalexin; Ciprofloxacin; Fosfomycin; Nitrofurantoin; Sulfamethoxazole; Trimethoprim

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 PVR > 200 mL, unwillingness or inability to initiate CIC post-treatment if required.

• Contraindication to oral antibiotics - hypersensitivity or allergy

• Inability to take medication by mouth