At a glance
ClinicalIndex Comparison Record- ✓Planned in-office bladder onabotulinumtoxinA injection
- ✓Age ≥18 years
- ✓Able to read, speak, and write in English
- ✓No hypersensitivity to botulinum toxin or formulation components
- ✕Current bladder catheterization for emptying
- ✕Unwilling or unable to initiate intermittent self-catheterization if required post-treatment
- ✕Last bladder onabotulinumtoxinA injection <3 months ago
- ✕Pregnant or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
In Brief
A Phase 4 clinical trial evaluating Single-Dose Antibiotic and Multi-Dose Antibiotic for Overactive Bladder and 3 related conditions. Completed, enrolled 100 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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