Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Completed
Columbia University
Phase 4
2015-03-01
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.
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