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Antibiotic Usage Prior to OnabotulinumtoxinA Injection

RecruitingNAAges 18 Years - anyAllBenaroya Research Institute
NCT04754737 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Intradetrusor injection of onabotulinumtoxinA, which is performed through a cystoscopic procedure, has been demonstrated to be efficacious in the treatment of both neurogenic and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for overactive bladder. Intradetrusor of onabotulinumtoxinA is currently standard of care of patients with OAB who have persistent OAB symptoms despite behavioral therapies and oral medication treatments for OAB. As one of the main adverse events associated with intradetrusor injection of onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic antibiotic is administered prior to this procedure. However, these recommendations are primarily based on data from randomized controlled trials (RCTs) involving antimicrobial proph

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📋 Eligibility rules (as published)
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.
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What it tests

  • No antibiotic
  • Prophylactic antibiotic
  • cystoscopic injection of onabotulinumtoxinA
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Where

1 site
Stony Brook Medicine
Stony Brook, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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