Study Population Participants will be recruited from all patients who are planning to undergo
gynecologic surgery by an attending surgeon in the Division of Urogynecology at Duke
University Medical Center (DUMC). After enrollment and randomization, the participants will
take the study drug once daily to start on post-operative day one and continue until the
participant has stopped catheterizing for up to one week after surgery. The participant will
also complete a daily diary for one week after surgery to record any catheterization and any
study drug or additional antibiotic medication taken. We will then follow patients for a
total of three weeks after surgery to monitor for treatment for UTI. At three weeks after
surgery the observation period for the participant is complete.
Sample Size Under the assumption of 80% power and an alpha error of 0.05, we would need 156
subjects to demonstrate a 66% reduction in risk of UTI (i.e. from 28% to 10%) in those
undergoing prophylactic antibiotic treatment. Therefore, we aim to recruit a total of 175
participants to account for participant dropout.
Study Definitions For our study purposes, post-operative catheterization will be defined to
include patients who are hospitalized post-operatively with an indwelling Foley catheter as
well as patients discharged with either intermittent self-catheterization (ISC) or indwelling
Foley catheter. The decision to catheterize will be determined by type of surgical procedure,
need for inpatient stay and void trial results. Void trials will be conducted as follows: the
bladder is backfilled with 300cc normal saline, the catheter is removed and the patient is
prompted to void immediately and, after voiding is complete, a (PVR) post-void residual
volume is measured. The patient passes the void trial if she voids over 200cc in total volume
or if her PVR is less than 100cc.
Our primary outcome of treatment for UTI within the first three weeks after surgery is to be
defined clinically. A patient will be considered to have received treatment for UTI if she
receives any antibiotic therapy for clinically suspected or culture-proven urinary tract
infection (i.e. empirically given upon development of urinary symptoms or prescribed based on
urinalysis or urine culture results) within the first three weeks after surgery.
Data Collection Demographic characteristics, operative data and post-operative data will be
collected. Prior to discharge after surgery all patients will undergo a void trial per
standard procedure unless they receive an indwelling Foley catheter for overnight
hospitalization. Post-operatively all subjects will be given a catheterization diary to
record days of catheterization and days of antibiotic therapy. All subjects will be
instructed to call our clinical office to report any urinary complaints and/or treatment for
UTI. Information will be collected from electronic medical records regarding any office
visits, urine cultures performed or treatment for UTI during this post-operative period. Data
will be entered into a de-identified study database for analysis by the PI and study
coordinator who will be blinded to participant randomization.
Subject Randomization and Blinding Study participants will be randomized to prophylactic
treatment versus no treatment via a computerized randomization scheme by the IDS at the time
of enrollment. Patients will be blinded to treatment by the utilization of placebo tablets.
Adverse Events Nitrofurantoin is FDA approved for the treatment of UTI. We will be using a
prophylactic dose and will monitor for any adverse events. Adverse events will be reported
per protocol. A safety monitoring designee will perform reviews on a designated basis
throughout the study.
Study Costs There will be no additional cost to the patient for their participation in this
study. No additional laboratory testing will be performed as a result of participation.
