Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency
NCT ID: NCT02757417
Last Updated: 2022-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2016-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.
sodium fluorescein
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.
phenazopyridine
Interventions
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sodium fluorescein
phenazopyridine
Eligibility Criteria
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Inclusion Criteria
* Patients undergoing a scheduled gynecologic procedure with cystoscopy
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Megan Billow
UNKNOWN
Graham Chapman
UNKNOWN
Sangeeta Mahajan
UNKNOWN
Alex Soriano
UNKNOWN
Sherif El-Nashar
UNKNOWN
University Hospitals Cleveland Medical Center
OTHER
Responsible Party
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Locations
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Countries
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Other Identifiers
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UHcaseMC1
Identifier Type: -
Identifier Source: org_study_id
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