Ureteral Injury
Conditions
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.
Interventions
Sponsors
Megan Billow
Graham Chapman
Sangeeta Mahajan
Alex Soriano
Sherif El-Nashar
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 | 12 months |
Countries
United States
Outcome results
None listed