Evaluating antibiotic use before onabotulinumtoxinA injections for overactive bladder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the necessity of prophylactic antibiotics prior to intradetrusor injections of onabotulinumtoxinA in patients with overactive bladder (OAB). It aims to optimize antibiotic usage by comparing outcomes between patients receiving antibiotics and those who do not. The study includes adults diagnosed with OAB who have not responded to standard therapies and ensures participants are not symptomatic for urinary tract infections (UTIs) at the time of injection. By addressing the appropriateness of antibiotic use, the study seeks to reduce unnecessary complications associated with antibiotic therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Stony Brook Medicine
  Stony Brook, New York, United States Recruiting

Study contacts

• Principal investigator: Justina Tam, MD — Stony Brook Medicine
• Study coordinator: Justina Tam, MD
• Email: justina.tam@stonybrookmedicine.edu
• Phone: 6314441910

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.