Antibiotic Use Before OnabotulinumtoxinA for Overactive Bladder

This study is looking at whether antibiotics are truly needed before an OnabotulinumtoxinA (Botox) injection for overactive bladder (OAB). OnabotulinumtoxinA is an FDA-approved treatment for OAB when other treatments haven't worked. Currently, a single dose of antibiotics is often given before the injection to prevent urinary tract infections (UTIs), which can be a side effect. This study will compare giving no antibiotics to giving a single dose of antibiotics before the OnabotulinumtoxinA injection. You may be able to join if you are at least 18 years old, have OAB that hasn't improved with other treatments, and do not have a UTI at the time of injection. The study will measure how many people get a UTI within 14 days after the injection. The current recruitment status is unclear, and the study plans to enroll 200 participants.

Study design
This is an interventional study comparing two groups: one receiving no antibiotics and one receiving prophylactic antibiotics before OnabotulinumtoxinA injection. It plans to enroll 200 participants.
What's involved
You would receive an OnabotulinumtoxinA injection into your bladder using a cystoscope (a thin, flexible tube with a camera). You would either receive a single dose of antibiotics or no antibiotics before this procedure.
Compensation
Not stated in the trial record.
Follow-up
The study will track whether you develop a symptomatic urinary tract infection for 14 days after the injection.

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NCT04754737

Antibiotic Usage Prior to OnabotulinumtoxinA Injection

Recruiting
NAAges 18+InterventionalPrevention
Benaroya Research Institute
~200 participants
Updated 2024-05-24 on ClinicalTrials.gov
What's tested:No antibioticProphylactic antibioticcystoscopic injection of onabotulinumtoxinA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
symptomatic UTI
Measured over 14 days
Antibiotic Stewardship
Overactive Bladder
Onabotulinumtoxin A
UTI
1 sites across 1 states
New York1
  • Justina Tam, MD · PRINCIPAL_INVESTIGATOR · Stony Brook Medicine

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Eligibility criteria

Inclusion

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

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.
  • symptomatic UTI14 days

    the number of symptomatic UTIs which occur within the 14 day period after cystoscopic intradetrusor injection of onabotulinumtoxinA