Phenazopyridine for Confirmation of Ureteral Patency (Phenazo)

October 11, 2016 updated by: Katie Propst, Hartford Hospital

Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No preoperative phenazopyridine
Experimental: Phenazopyridine
Preoperative phenazopyridine
Drug: Phenazopyridine
Other Names:
  • Pyridium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
Time Frame: 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.
Day of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician Confidence Measured by a Survey
Time Frame: 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
day of surgery (day 0)
Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
Time Frame: 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
day of surgery (day 0)
Post-operative Urethral Discomfort Measured by Pain Scales
Time Frame: 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.
post operative day 1
Trial of Void Results
Time Frame: 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.
Day of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 17, 2015

First Posted (Estimate)

April 22, 2015

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

October 11, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • HHC-2015-0008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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