Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

University Hospitals Cleveland Medical Center

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Ureteral Injury

Interventions

sodium fluoresceinDRUG

phenazopyridineDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups

Time frame: 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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