Bladder OnabotulinumtoxinA Antibiotic Prophylaxis: A Prospective RCT.

IMPORTANCE

Bladder onabotulinumtoxinA (BoNT-A) is a widely used third-line treatment for overactive bladder (OAB). The most common adverse event is postprocedure urinary tract infection (UTI), yet there are no specific guidelines for antibiotic prophylaxis for this procedure.

OBJECTIVES

Our primary aim was to establish noninferiority in the incidence of postprocedure UTI with single versus multiple-dose peri-procedural antibiotics. Our secondary aim was to describe the rates of adverse events in each group, including urinary retention requiring catheterization.

STUDY

DESIGN

Adults undergoing office-based bladder BoNT-A were enrolled in this prospective, nonblinded, randomized noninferiority trial. Exclusion criteria included recurrent UTI or urinary retention. Patients were randomized 1:1 into 2 treatment arms: single dose versus 3 days of postprocedural antibiotics. Antibiotic choice was based on patient allergies, previous urine cultures, and drug interactions. Patients were assessed at 4 weeks postprocedure for any interval UTI treatment, urine culture results, retention, or adverse effects.

RESULTS

We recruited 96 women with a mean age of 67 years. Patient characteristics and comorbidities were similar between groups ( P >0.05). One patient in each arm (2%) developed UTI following BoNT-A ( P =0.95), which did not meet the noninferiority definition due to the low incidence overall. One patient developed retention requiring catheterization, and 1 developed a vaginal yeast infection, both in the multidose arm.

CONCLUSIONS

This study suggests that a single dose of oral antibiotics is sufficient for the prevention of UTI with office injection of bladder BoNT-A for uncomplicated OAB, though further research is warranted to assess the applicability to a broader population.