Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Condition: Overactive Bladder; Overactive Bladder Syndrome; Urge Incontinence; Urinary Incontinence, Urge
MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge
Intervention: Single-Dose Antibiotic; Multi-Dose Antibiotic
Intervention description: Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure
Second line:
Arm 1: cefalexin 500 mg once pre-procedure
Third line:
Arm 1: nitrofurantoin 100 mg once pre-procedure
Fourth line:
Arm 1: ciprofloxacin 500 mg once pre-procedure; Allergy, prior urine culture resistance or another contraindication to first line antibiotic will result in the patient being prescribed second line antibiotic and so forth.
First line:
Arm 2: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure plus 800/160 mg every twelve hours for 6 total doses
Second line:
Arm 2: cefalexin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Third line:
Arm 2: nitrofurantoin 100 mg once pre-procedure plus 100 mg every twelve hours for 6 total doses
Fourth line:
Arm 2: ciprofloxacin 500 mg once pre-procedure plus 500 mg every twelve hours for 6 total doses
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Men and women 18 years of age or older with refractory overactive bladder or neurogenic bladder will be randomized in a 1:1 ratio into one of two groups until the targeted sample size is met:
The single dose group will receive one dose of antibiotic prior to intradetrusor Botox injection.
Individuals in the multi-dose group will receive one dose of antibiotic prior to intradetrusor Botox injection and additional antibiotics for a total of three days of antibiotic administration.
Random permuted block randomization with block sizes of 2, 4, 6, and 8 will be used to assign eligible patients to treatment groups
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: incontinence; overactive bladder; urge incontinence

Summary:

      The goal of this clinical trial is to evaluate the outcomes of differing durations of
      antibiotic prophylaxis with bladder onabotulinumtoxinA injection in patients with refractory
      overactive bladder.

      The main question it aims to answer are:

      • Is the incidence of post-procedure UTI similar between single-dose and multi-day durations
      of peri-procedural antibiotics?

      Participants will be randomized to single-dose versus multi-day dose of antibiotic
      prophylaxis with bladder onabotulinumtoxinA injection.

      Researchers will compare incidence of UTI in each group to see if there is a significant
      difference.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with planned in-office bladder onabotulinumtoxinA injection

          -  Men or Women Age ≥ 18

          -  Able to read, speak, and write in English

          -  No contraindication to injection of onabotulinumtoxinA - hypersensitivity to any
             botulinum toxin preparation or to any of the components in the formulation

          -  Willingness and ability to initiate intermittent catheterization post-treatment if
             required

          -  No contraindication to oral antibiotics

          -  No active antibiotic therapy for any indication at the time of onabotulinumtoxinA
             injection

          -  Have not participated in this study before

        Exclusion Criteria:

          -  Any type of catheterization to empty the bladder

          -  Unwillingness or inability to initiate intermittent catheterization post-treatment if
             required

          -  Less than 3 months since last bladder onabotulinumtoxinA injection

          -  Pregnant and/or breastfeeding

          -  Active symptomatic UTI the day of the procedure - new or worsening frequency, urgency,
             dysuria, hematuria, suprapubic/flank pain, fevers or chills

          -  History of recurrent UTI

          -  Prior development of urinary retention or incomplete bladder emptying after bladder
             onabotulinumtoxinA injection requiring catheterization of any type