Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency

To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.

Study Overview

• Status: Withdrawn
• Conditions: Ureteral Injury
• Intervention / Treatment: Drug: sodium fluorescein; Drug: phenazopyridine

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

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:

• - Patients must be 18 years or older as well as willing and able to provide informed consent
• Patients undergoing a scheduled gynecologic procedure with cystoscopy

Exclusion Criteria:

• - Patients are younger than 18 years
• Patients are unable or unwilling to provide informed consent
• Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
• Patients with a history of renal insufficiency
• Patients with a history of liver disease
• Patients with a history of sickle cell disease
• Patients with a history of glucose-6-phosphate dehydrogenase deficiency
• Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium Fluorescein; Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation.	Drug: sodium fluorescein
Active Comparator: oral phenazopyridine; Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation.	Drug: phenazopyridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0	12 months

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Megan Billow; Graham Chapman; Sangeeta Mahajan; Alex Soriano; Sherif El-Nashar

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 27, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): May 6, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UHcaseMC1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided