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Bladder Botox UTI Antibiotic Prophylaxis

RecruitingPhase 4Ages 18 Years - anyAllWalter Reed National Military Medical Center
NCT06387329 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Overactive bladder (OAB) is a common condition with a prevalence of 17% in the general population that significantly affects quality of life. Intradetrusor onabotulinumtoxinA injections are an advanced therapy for OAB as well as interstitial cystitis/bladder pain syndrome (IC/BPS). The most common adverse event following intradetrusor injection of onabotulinumtoxinA in urinary tract infection (UTI), which occurs in 8.6-48.1% of patients. To prevent UTIs, patients are given a course of antibiotics, however the ideal prophylactic regimen has not been determined for the timing, duration, and type of antibiotic. Four retrospective studies in the literature address this question with variable conclusions, and there are no prospective studies. Identifying the ideal regimen is important for preventing UTIs as well as minimizing antibiotic use to prevent adverse effects and development of antibi

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📋 Eligibility rules (as published)
Inclusion Criteria: * All patients 18 years or older being seen at the WRNMMC Urogynecology clinic * Diagnosis of OAB or IC/BPS * Planning to undergo intradetrusor onabotulinumtoxinA injection for treatment of their OAB or IC/BPS * Ability to follow instructions and complete follow up Exclusion Criteria: * Contraindication to nitrofurantoin (allergy, CrCl \<30mL/minute) * If performed in the operating room, the patient cannot undergo a concurrent procedure that would increase the risk of UTI or require an alternate antibiotic regimen (such as hysterectomy, prolapse repair, or anti-incontinence procedure) * Active UTI at the time of procedure * Neurogenic bladder * Recurrent UTI (3 in 12 month period or 2 in 6 months) * Post void residual bladder volume ≥150mL * Patient is already taking antibiotics at the time of the procedure * Contraindication to onabotulinumtoxinA (allergy, pregnancy, greater than 400 units of onabotulinumtoxinA received in the last 3 months)
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What it tests

  • Nitrofurantoin 100 MG
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Where

1 site
Walter Reed National Military Medical Center
Bethesda, 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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