Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

University Hospitals (UH)

Status: Withdrawn

Conditions: Ureteral Injury

Treatments: Drug: phenazopyridine; Drug: sodium fluorescein

Study type: Interventional

Funder types: Other

Identifiers

NCT02757417

UHcaseMC1

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Sodium Fluorescein

Active Comparator group

Description:

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.

Treatment:

Drug: sodium fluorescein

oral phenazopyridine

Active Comparator group

Description:

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.

Treatment:

Drug: phenazopyridine