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

NCT03432572 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-08-11

No results posted yet for this study

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.

Conditions

  • Ureteral Injury

Interventions

DRUG

Pyridium

a urine discoloration agent

DRUG

Riboflavin

a urine discoloration agent

DRUG

Thiamine

active placebo not known to cause urine discoloration

Sponsors & Collaborators

  • Texas Tech University Health Sciences Center

    lead OTHER

Principal Investigators

  • Cornelia DeRiese, MD · Texas Tech University Health Sciences Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-27
Primary Completion
2020-06-30
Completion
2020-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03432572 on ClinicalTrials.gov