Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

University Hospitals (UH) logo

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Withdrawn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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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