Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
Recruiting now · Phase 4
Conditions studied: Antibiotic Prophylaxis
In brief
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.
Key facts
- Study ID
- NCT05519072
- Run by
- Atlantic Health System
- People needed
- 140
- Starts
- 2022-08-16
- Expected to finish
- 2024-08-16
- Last updated by the study team
- 2024-03-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Female
- Age ≥ 18
- Patient undergoing bladder Botox treatment
You may not qualify if…
- 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
Where it is running
- Atlantic Health — Morristown, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.