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

NCT03432572 | Completed Early Phase 1 FDA Drug

• 1 other identifier: L18-072
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• urine discoloration on cystoscopy

  To determine if oral pyridium and vitamin B riboflavin administration prior to gynecologic procedures are effective and safe alternatives for evaluating ureteral patency at the time of cystoscopy.

  through study completion, an average of 1 year

Study Arms (3)

pyridium

EXPERIMENTAL

Group A will take 200 mg of oral Pyridium 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.

Drug: Pyridium

riboflavin

ACTIVE COMPARATOR

Group B will take 400 mg of riboflavin 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.

Drug: Riboflavin

thiamine

PLACEBO COMPARATOR

Group C will take the placebo (50 mg of thiamine) 1 hour before surgery and then the urine jets will be evaluated on cystoscopy in the operating room during a gynecological procedure.

Drug: Thiamine

Interventions

Pyridium DRUG

a urine discoloration agent

Also known as: Group A

pyridium

Riboflavin DRUG

a urine discoloration agent

Also known as: Group B

riboflavin

Thiamine DRUG

active placebo not known to cause urine discoloration

Also known as: Group C

thiamine

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 to 75 years.
• Female patients ages who are scheduled to undergo gynecologic procedures where cystoscopy/need to determine ureteral patency may be indicated.
• Being seen in the department of Texas Tech OB/GYN.
• Willing to be randomized.
• Have not taken, or willing to stop taking pyridium or riboflavin at least 7 days prior to surgery.

You may not qualify if:

• Female patients who are found to have one of the following conditions based on their medical history: Active Inflammation of the Liver, Glomerulonephritis, Uremia, Kidney Disease, Glucose-6-Phosphate Dehydrogenase (G6PD) Deficiency, Anemia from Pyruvate Kinase and G6PD Deficiency.
• Patients who have allergies to pyridium, riboflavin, or vitamin B1 riboflavin.
• Patients who, for whatever reason, did not receive the product they were randomized to receive.

Sponsors & Collaborators

• Texas Tech University Health Sciences Center: lead

Study Sites (1)

Texas Tech University Health Sciences Center

Lubbock, Texas, 79430, United States

Location

MeSH Terms

Interventions

Phenazopyridine; Riboflavin; Thiamine

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Coenzymes; Enzymes and Coenzymes; Pigments, Biological; Biological Factors; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Pyrimidines

Study Officials

• Cornelia DeRiese, MD

  Texas Tech University Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The interventions will be blinded to the investigator, the care providers (surgeons), and will be blinded to the patients in the study
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a 3 arm randomized controlled double blinded study. The arms will all be studied in parallel to each other and compared in their effectiveness for evaluation for urine jets on cystoscopy.

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: June 27, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

US (1)