Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

Ureteral Injury Clinical Trial

Official title:

A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02757417
• Other study ID #: UHcaseMC1
• Status: Withdrawn
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2022
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2019
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ureteral Injury

Intervention

Drug:
• sodium fluorescein

• phenazopyridine

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (6)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Alex Soriano, Graham Chapman, Megan Billow, Sangeeta Mahajan, Sherif El-Nashar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups		12 months
Secondary	number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0		12 months