Phenazopyridine for Confirmation of Ureteral Patency

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Females only
Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
Age > or = 18 years, no upper age limit
Able and willing to consent

Exclusion Criteria

Planned surgical procedure where cystoscopy will not be used
Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
age <18 years
pregnancy
unable/unwilling to participate
history of allergy or adverse reaction to phenazopyridine
hepatic dysfunction
known phenazopyridine hypersensitivity
history of urologic surgery
presence of ureteral stents prior to the planned surgical procedure
concomitant suprapubic catheter placement

Arm && Interventions

Group	Intervention	Description
Phenazopyridine	Phenazopyridine	Preoperative phenazopyridine

Primary Outcome Measures

Name	Time	Method
Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room	Day of surgery	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.

Secondary Outcome Measures

Name	Time	Method
Physician Confidence Measured by a Survey	day of surgery (day 0)	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
Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR	day of surgery (day 0)	this is a composite measure and will be reported as a single value for each arm as number of additional interventions
Post-operative Urethral Discomfort Measured by Pain Scales	post operative day 1	Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.
Trial of Void Results	Day of hospital discharge	Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.