Comparison of Methods for Prevention of Urinary Tract Infection Following Botox Injection
Condition: Overactive Bladder; Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Urinary Bladder, Overactive
Intervention: Periprocedural Antibiotics; Extended Antibiotics; Injection of OnabotulinumtoxinA (BTX-A)
Intervention description: One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection.; Patients randomized to the "Extended Antibiotics" arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days.
For their second injection, they will receive peri-procedural antibiotics only.; Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular; Trimethoprim; Sulfamethoxazole; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Onabotulinumtoxin

Summary:

      Injection of OnabotulinumtoxinA (BTX-A) into the bladder is a widely used treatment option
      for patients with overactive bladder who have failed medical therapy. Urinary tract infection
      is the most common side effect of this procedure and therefore antibiotics are given around
      the time of injection in order to prevent these events. While antibiotics are commonly given
      at the time of injection, the duration of these antibiotic regimens are variable. The
      investigators propose a study to investigate different antibiotic protocols and their affect
      on the rate of urinary tract infection after injection.
    

Eligibility criteria:

        Inclusion criteria:

          -  ≥ 18 years of age

          -  Medication refractory OAB, identified per American Urological Association guidelines

        Exclusion criteria:

          -  Post void residual urine >150ml on two occasions

          -  Untreated, symptomatic UTI

          -  Comorbid neurological conditions, including spinal cord injury, systemic neurologic
             illnesses (i.e. multiple sclerosis, Parkinson's disease) or central nervous system
             disease (i.e. brain tumor, stroke)

          -  Prior pelvic irradiation

          -  Current or prior bladder malignancy

          -  Hematuria lacking a clinically appropriate evaluation

          -  Chronic indwelling or intermittent catheterization