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Completed Early Phase 1 Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT03432572

Public ClinicalTrials.gov record NCT03432572. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:48 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03432572
Recruitment status
Completed
Study type
Interventional
Phase
Early Phase 1
Enrollment
120 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
21 Years to 75 Years
Sex
Female
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 26, 2018
Primary completion
Jun 29, 2020
Completion
Jun 29, 2020
Last update posted
Aug 10, 2020

2018 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Texas Tech University Health Sciences Center Lubbock Texas 79430

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03432572, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 10, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03432572 live on ClinicalTrials.gov.

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