← Back to all trials
Enrolling By Invitation
NCT05719285
Single-Dose Versus Multi-Dose Prophylactic Antibiotic Administration for Bladder OnabotulinumtoxinA Injection
Conditions: Overactive Bladder, Overactive Bladder Syndrome, Urge Incontinence, Urinary Incontinence, Urge
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 100
Sponsor: The Cleveland Clinic
Location: United States
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 injectionMen or Women Age ≥ 18Able to read, speak, and write in EnglishNo contraindication to injection of onabotulinumtoxinA - hypersensitivity to any botulinum toxin preparation or to any of the components in the formulationWillingness and ability to initiate intermittent catheterization post-treatment if requiredNo contraindication to oral antibioticsNo active antibiotic therapy for any indication at the time of onabotulinumtoxinA injectionHave not participated in this study beforeExclusion Criteria:Any type of catheterization to empty the bladderUnwillingness or inability to initiate intermittent catheterization post-treatment if requiredLess than 3 months since last bladder onabotulinumtoxinA injectionPregnant and/or breastfeedingActive symptomatic UTI the day of the procedure - new or worsening frequency, urgency, dysuria, hematuria, suprapubic/flank pain, fevers or chillsHistory of recurrent UTIPrior development of urinary retention or incomplete bladder emptying after bladder onabotulinumtoxinA injection requiring catheterization of any type
Source: ClinicalTrials.gov (NCT05719285). StuddyBuddy aggregates publicly available trial information.
