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Antibiotic Prophylaxis for Bladder Botox

RecruitingPhase 4Ages 18 Years - anyFemaleUniversity of Alberta
NCT04444440 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Injection of Botox into the bladder is a common treatment for overactive bladder. Postoperative bladder infection is one of the more frequently reported complications of this procedure. Prophylactic antibiotics given at the time of bladder Botox for the reduction of postoperative bladder infection have not been well studied. The main goal of our study is to determine if prophylactic antibiotics at the time of bladder Botox injection for the treatment of overactive bladder in women reduces postoperative bladder infection. The investigators are proposing a study which will randomize participants into two groups - one receiving Ciprofloxacin and the other receiving placebo pills for three days following the procedure. The primary outcome evaluated will be the difference in postoperative bladder infection between the two groups. The investigators will also investigate differences in reported

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with idiopathic OAB diagnosed clinically who have failed medical management * Female * Age ≥ 18 Exclusion Criteria: * Patients with neurogenic OAB (OAB with potential underlying neurologic cause - multiple sclerosis, spinal cord injury, Parkinson's disease, other) * Contraindication to injection of Botox - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation, current urinary tract infection, symptomatic urinary retention or PVR \> 200 mL, unwillingness or inability to initiate CIC post-treatment if required. * Contraindication to oral Ciprofloxacin - hypersensitivity or allergy to Ciprofloxacin or other fluoroquinolone, concurrently taking Tizanidine or Agomelatine.14 * Active antibiotic therapy for any indication at the time of Botox injection - increased risk of adverse reaction with combining antibiotics, reduced risk of UTI with additional antibiotic. * Male * Age \< 18 * Pregnant and/or breastfeeding
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What it tests

  • Ciprofloxacin
  • Placebo Pill
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Where

1 site
Urogynecology Clinic - Royal Alexandra Hospital
Edmonton, Canada
🤝 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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