Phenazopyridine for Confirmation of Ureteral Patency

Study Overview
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Brief Summary
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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.

Official Title
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Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy

Conditions
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Cystoscopy

Intervention / Treatment
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* Drug: Phenazopyridine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>No preoperative phenazopyridine | |
| Experimental: Phenazopyridine<br>Preoperative phenazopyridine | Drug: Phenazopyridine<br> <br> * Other names: Pyridium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | Day of hospital discharge |