Can Investigators Reduce Urinary Catheter Use and Lower Urinary Tract Infection Among Women Undergoing Benign Gynecologic Surgery?

METHODS:

This study will be conducted at The Christ Hospital. Informed consent will be obtained from
the patients in the pre-operative care unit prior to administration of any medications.
Candidates for the study will clearly understand consenting to enroll in the study includes
not only the randomized assignment of urinary catheter care postoperatively but also a
follow-up phone survey to be administered approximately 2 weeks after discharge. Patient
reasons for not enrolling in the study will be recorded.

Study population All women presenting to The Christ Hospital for gynecologic surgery
anticipated to require an at least 1 night stay and in whom would be expected to have an
indwelling catheter overnight are eligible to participate in the study. Patients with a
current urinary tract infection being treated with antibiotic(s), anticipated concomitant
prolapse or incontinence surgery, a preoperative diagnosis of gynecologic malignancy, a
history of chronic indwelling catheter use, a history of renal transplant or current dialysis
use, or intraoperative lower urinary tract injury necessitating prolonged postoperative
catheter use are to excluded from study participation. Following application of the inclusion
and exclusion criteria, postoperative urinary catheter care (conventional vs. fast track)
will randomized upon arrive to the postoperative care unit (PACU). These patients will
compose the study population.

Protocol:

Per routine anesthesia practice once a patient has met criteria for discharge from the PACU,
and following randomization into either the conventional or fast track cohorts, the subject
will either have immediate removal of the catheter with a trial of void or the catheter will
remain in place over night per routine practice with a trial of void arranged at the time of
discharge.

The trial of void protocol will consist of backfilling the existing catheter with 300cc of
sterile saline (or to a volume the patient reports to be subjectively full) and recording her
voided volume that should occur within 30 minutes. The patient's self-reported percent of
normal force of stream will be recorded (0-100% in 10% increments) along with her voided
volume. If the patient voids at least 150cc of the instilled volume OR reports at least a
>50% of normal force of stream she will be considered to have passed the voiding trial. The
patient will be scanned for residual urine volume following the next spontaneous void or any
time she reports symptoms consistent with obstructed voiding.

Duration of catheter use will be determined as the time from placement in the operating room
(time 0) to the time it is removed on the hospital ward. Time will be recorded in hours.
Discharge from the hospital will occur per the attending physician's routine practice. At
hospital discharge subjects will complete a brief survey recording bladder function before
and during their hospitalization. Also included in this survey will be an assessment of their
overall satisfaction with their catheter management and hospital stay. Institution standard
practice is to obtain a urinalysis in the operating room on all patients anticipating an
overnight stay. This urinalysis and any other urine studies obtained during the
hospitalization will be extracted from the medical record. The number of subjects who fail
the trial of voiding between cohorts will be collected from the electronic medical record
(EMR). After discharge, subjects will be contacted by phone 2-3 weeks after the index
surgery. At this call subjects will be administered a survey reviewing their post-surgery
bladder function including symptoms of a bladder infection. A review of the patient's
hospital record will also be conducted to identify any additional urine studies ordered
during the 2-3 weeks following surgery.

Randomization protocol: Permuted block randomization will be used to ensure a balanced
enrollment of patients in the clinical trial. Selecting a block size of 4 will ensure that
for every four patients enrolled, 2 will be assigned to the "Fast-track" cohort and 2 will be
assigned to the "Conventional" cohort. In order to effectively conceal the randomization
sequence, investigators will use sequentially numbered, opaque sealed envelopes (SNOSE). It
will not be feasible to blind the physician, nurse and patient in this study, they will all
be aware of the randomized allocation assignment. The study personnel administering the
postoperative telephone questionnaires will be blinded by simply not informing them of the
group allocation of the patient. Plans to manage incomplete data between cohorts will include
meeting with nursing managers and supervisors to ensure that questions are completed and to
verify how to enter information into the EMR. At the completion of the study every effort
will be made to have all patient questionnaire completed.

Inclusion Criteria:

- All women, over the age of 18, presenting to The Christ Hospital for gynecologic
surgery anticipated to require an at least 1 night stay and in whom would be expected
to have an indwelling catheter overnight are eligible to participate in the study.

Exclusion Criteria:

- Patients with a current urinary tract infection being treated with antibiotic(s),
anticipated concomitant prolapse or incontinence surgery, a preoperative diagnosis of
gynecologic malignancy, a history of chronic indwelling catheter use, a history of
renal transplant or current dialysis use, or intraoperative lower urinary tract injury
necessitating prolonged postoperative catheter use are to excluded from study
participation.