Actively Recruiting
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
Led by Atlantic Health System · Updated on 2024-03-27
140
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Atlantic Health System
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Age 18 years or older
- Patient undergoing bladder Botox treatment
You will not qualify if you...
- Pregnant and/or breastfeeding
- Allergy or hypersensitivity to botulinum toxin or any component of its formulation
- Symptomatic urinary retention or post void residual greater than 200 mL
- Unwillingness or inability to start clean intermittent catheterization after treatment if needed
- Allergy or hypersensitivity to oral antibiotics
- Inability to take medication by mouth
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Atlantic Health
Morristown, New Jersey, United States, 07962-1905
Actively Recruiting
Research Team
A
Anastasiya Holubyeva, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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