At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
In Brief
A Phase 4 clinical trial evaluating Pyridium, Sodium Fluorescein, and 2 other interventions for Ureteral Patency. Completed, enrolled 140 participants across 1 site.
Detailed Summary
Many gynecologic, urologic and pelvic reconstructive surgeries require accurate ways to identify the opening of the ureters to ensure that they are working correctly. Historically, indigo carmine, an intravenous medication that dyes the urine blue, has been used to help visualize the opening of the ureters with cystoscopy which is a camera placed inside the bladder. In June 2014, the FDA announced there was current shortage of indigo carmine. Thus, investigators need to evaluate other methods for assessing ureteral patency. Ideal alternatives are agents that are low-risk, inexpensive, provide comparable visualization, are readily available and are easy to use. Examples of such agents currently being used to evaluate the ureters, include oral pyridium, IV sodium fluorescein, and mannitol. These agents help identify the opening of the ureters by either dyeing the urine a different color such as pyridium and sodium fluorescein, or by having a different viscosity to urine such as mannitol. This study will compare three methods of evaluating ureteral patency at time of cystoscopy compared to no method: mannitol, sodium fluorescein, and pyridium.