Antibiotic Usage Prior to OnabotulinumtoxinA Injection

Launched by BENAROYA RESEARCH INSTITUTE · Feb 12, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at whether patients with overactive bladder (OAB) who are not showing any symptoms of a urinary tract infection (UTI) really need to take antibiotics before receiving an injection of onabotulinumtoxinA (commonly known as Botox) into their bladder. Currently, doctors often give antibiotics as a precaution to prevent UTIs, but this study aims to find out if that is necessary for patients who have a negative urine test and are symptom-free. The goal is to use antibiotics more wisely and avoid unnecessary side effects from them, like infections or allergic reactions.

To participate in this study, you need to be at least 18 years old and have OAB that hasn’t improved after trying other treatments like bladder training or medication. You should also not have any UTI symptoms and have a negative urine test on the day of the injection. Participants will be randomly assigned to either receive the antibiotic or not before their procedure. This trial is a chance to help improve treatment practices for OAB while ensuring patients avoid unnecessary antibiotic use.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18
• • Diagnosis of OAB who have failed 1st and 2nd line therapies per the AUA/SUFU OAB guidelines (including bladder training, dietary modification and pharmacotherapy with an anticholinergic and/or beta-3 agonist)
• • Not symptomatic for UTI at the time of injection
• • Negative urinalysis at the time of the injection defined as: negative for nitrites and leukocyte esterace, with urine white blood cell count less than 5 per high-power field
• • Consent to participate in the study.
• Exclusion Criteria:
• • Antibiotic usage within 48 hours prior to intradetrusor onabotulinumtoxinA injection
• • Women who are pregnant or planning to become pregnant, women who are breastfeeding
• • Concurrent use of onabotulinumtoxinA injection with maximum cumulative dose exceeding 400 units in a 3-month interval.