In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
107
Hartford Hospital
Hartford, Connecticut, United States
Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.
Time frame: Day of surgery
Physician Confidence Measured by a Survey
Surgeon response to the question: "I am confident that ureteral injury was ruled out in this patient" on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree
Time frame: day of surgery (day 0)
Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
this is a composite measure and will be reported as a single value for each arm as number of additional interventions
Time frame: day of surgery (day 0)
Post-operative Urethral Discomfort Measured by Pain Scales
Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.
Time frame: post operative day 1
Trial of Void Results
Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.
Time frame: Day of hospital discharge
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