Overview

Investigating Oral Agents for Urine Staining to Facilitate Intraoperative Observation of Ureteral Jets

Status:
Completed
Trial end date:
2020-06-30
Target enrollment:
Participant gender:
Summary
Recently, Indigo Carmine and Methylene Blue have been the standard agents to visualize ureteral jets during intraoperative cystoscopy. However, due to a national shortage of Indigo Carmine and Methylene Blue, there is a need to discover alternative IV and oral agents that are readily available and well tolerated when used for visualizing ureteral jets at the time of intraoperative cystoscopy. The aim of this study is to look at oral agents that have been studied such as pyridium (Phenazopyridine Hydrochloride) and riboflavin and compare them in a three-arm double-blinded randomized controlled pilot study using riboflavin, pyridium, and a placebo. The aim of the study is to provide evidence that both pyridium and riboflavin are effective and safe for staining urine to facilitate visualization of jets in evaluating ureteral patency at the time of intraoperative cystoscopy.
Phase:
Early Phase 1
Details
Lead Sponsor:
Texas Tech University Health Sciences Center
Treatments:
Riboflavin
Thiamine