Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

Not Applicable

Withdrawn

• Conditions: Ureteral Injury
• Interventions: Drug: sodium fluorescein; Drug: phenazopyridine

• Registration Number: NCT02757417
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Start: 2016-07
• Primary Completion: 2018-01
• Study Completion: 2019-12
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Fluorescein	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.
oral phenazopyridine	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.

Primary Outcome Measures

Name	Time	Method
differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups	12 months

Secondary Outcome Measures

Name	Time	Method
number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0	12 months

Trial Locations

Locations (1)

University Hospitals Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States