Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

NCT02757417 | Withdrawn DMC

• 1 other identifier: UHcaseMC1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Ureteral Injury

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (1)

• number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0

  12 months

Study Arms (2)

Sodium Fluorescein

ACTIVE COMPARATOR

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

oral phenazopyridine

ACTIVE COMPARATOR

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

Interventions

sodium fluorescein DRUG

Sodium Fluorescein

phenazopyridine DRUG

oral phenazopyridine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Megan Billow: collaborator
• Graham Chapman: collaborator
• Sangeeta Mahajan: collaborator
• Alex Soriano: collaborator
• Sherif El-Nashar: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Fluorescein; Phenazopyridine

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

US (1)