Intradetrusor injection of onabotulinumtoxinA, which is performed thorough a cystoscopic
procedure, has been demonstrated to be efficacious in the treatment of both neurogenic
and non-neurogenic overactive bladder (OAB), and is FDA approved as a treatment for OAB.
Intradetrusor of onabotulinumtoxinA is currently standard of care in patients with
persistent OAB symptoms despite behavioral therapies and oral medication treatments for
OAB. As one of the main adverse events associated with intradetrusor injection of
onabotulinumtoxinA is UTI, and published guidelines for cystoscopic procedures with
manipulation recommend the use of prophylactic antibiotics, a single dose of prophylactic
antibiotic is administered prior to this procedure as the current standard of care.
However, the guideline recommendations are primarily based on data from randomized
controlled trials (RCTs) involving antimicrobial prophylaxis during transurethral
resection of the prostate, and does not address cystoscopic injection procedures like
onabotulinumtoxinA injection. Studies have reported that up to 50% of antibiotic usage is
inappropriate, leading to unnecessary exposure of patients to potential complications of
antibiotic therapy, including Clostridium difficile infection which can cause recurrent
diarrhea that may progress to sepsis and death, increasing antibiotic resistances, as
well as dermal/allergic and gastro-intestinal manifestations. In an effort to optimize
antibiotic usage, antimicrobial stewardship is required in nursing facilities, acute-care
and critical care hospitals, as well as ambulatory care centers. These efforts highlight
the importance of re-evaluating our current practice standard of prophylactic antibiotic
administration in urologic procedures. A prospective study that included patients
undergoing intradetrusor onabutulinumtoxin injections who were not symptomatic for UTI
and did not receive antibiotic prophylaxis demonstrated that the rate of post-procedure
UTI within 6 weeks of treatment was not significantly different in those with a sterile
urine culture compared to those with asymptomatic bacteriuria, suggesting that in
patients who are not symptomatic for UTI, antibiotic prophylaxis may not be necessary
prior to intradetrusor onabotulinumtoxin injection. To date, there have been no
randomized studies that evaluate differences in outcomes when prophylactic antibiotics
are not given prior to onabotulinumtoxinA injection. Therefore, in an effort to optimize
antibiotic use, the investigators propose a prospective, randomized study to formally
investigate whether there is a difference in the rate of symptomatic post-procedure UTI
after intradetrusor onabotulinumtoxin when antibiotic prophylaxis is given compared to
when antibiotic prophylaxis is not given in patients who are not symptomatic for UTI and
have a negative urinalysis. The proposed study seeks to evaluate the current practice
standard of antibiotic prophylaxis prior to intradetrusor onabotulinumtoxin injection.
