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Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02757417
Recruitment Status : Withdrawn (Study never started)
First Posted : May 2, 2016
Last Update Posted : May 6, 2022
Sponsor:
Collaborators:
Megan Billow
Graham Chapman
Sangeeta Mahajan
Alex Soriano
Sherif El-Nashar
Information provided by (Responsible Party):
University Hospitals Cleveland Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ureteral Injury Drug: sodium fluorescein Drug: phenazopyridine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
Actual Study Start Date : July 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : December 2019

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757417


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Megan Billow
Graham Chapman
Sangeeta Mahajan
Alex Soriano
Sherif El-Nashar
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02757417    
Other Study ID Numbers: UHcaseMC1
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided