Evaluation of Ureteral Patency in the Post-indigo Carmine Era

NCT02677623 | Completed Phase 4 Results

• 1 other identifier: AAAP3450
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ureteral Patency

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  This is a 10-cm visual analog scale to determine which method of evaluating ureteral patency is most satisfactory to physicians. The smiley face is at one end and the frowning face is at the other end. Smiling is 1 and frowning is 10. The scale is completed by surgeon, anesthesiologist and the circulator by placing an "x" or a "mark" anywhere on the 10 cm line towards how good and or bad each person felt about the of process of patency assessment that was used. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from a minimum of 0 to a maximum of 100. A higher score indicates greater pain intensity (worse outcome).

  Intraoperative

Study Arms (4)

A- Pyridium

EXPERIMENTAL

* Method of administration: oral * Dose: 200 mg PO with small sip of water * Known adverse events: yellow discoloration of skin or sclera, 1-10% central nervous system effects including headache and dizziness, GI effect of cramping, \< 1% acute renal failure, methemoglobinemia, hemolytic anemia, hepatitis, rash, skin pigmentation, vertigo, stomach cramps * Contraindications: to be used in caution in patients with renal impairment Cr Cl \< 50ml/minute and in patients who are receiving nitric oxide, prilocaine and sodium nitrite as it can cause methemoglobinemia

Drug: Pyridium

B- Sodium Fluorescein

EXPERIMENTAL

* Method of administration: intravenous * Dose: 25 mg * Known adverse events: nausea, vomiting, flushing or rash, hypersensitivity and anaphylactic reactions can occur following injection and immediate treatment with epinephrine should be available, skin and urine discoloration (urine may appear bright yellow for 24-36 hours), extravasation may cause skin sloughing, toxic neuritis and phlebitis, nausea, rare cardiac arrest and seizure, * Contraindications: use with caution in patients with history of hypersensitivity, allergies or asthma

Drug: Sodium Fluorescein

C- Mannitol

EXPERIMENTAL

* Method of administration: irrigant during cystoscopy * Dose: 300cc during cystoscopy to visualize the ureters * Known adverse events: dysuria, polyuria, hyponatremia with excess absorption, potential increased risk of urinary tract infection * Contraindications when used as a genitourinary irrigation solution: anuria

Drug: Mannitol

Control- Normal saline

EXPERIMENTAL

* Method of administration: irrigant during cystoscopy * Dose: 300cc * Known adverse events: no known significant adverse events * Contraindications: none

Other: Normal Saline

Interventions

Pyridium DRUG

A- Pyridium

Sodium Fluorescein DRUG

B- Sodium Fluorescein

Mannitol DRUG

C- Mannitol

Normal Saline OTHER

Control- Normal saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Planned cystoscopy

You may not qualify if:

• Women who are pregnant
• Women with contraindications to pyridium, sodium fluorescein or mannitol:
• Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
• Anuria
• Women with creatinine greater than 1 or Cr Cl \< 50ml/minute
• Known allergy to pyridium, sodium fluorescein or mannitol.
• Women with a known urologic anatomical anomaly

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Interventions

Phenazopyridine; Fluorescein; Mannitol; Saline Solution

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds; Sugar Alcohols; Alcohols; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Nisha Philip, Clinical Research Manager
• Organization: Columbia University

np2173@cumc.columbia.edu

212-305-4973

Study Officials

• Cara Grimes, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2016
• First Posted: February 9, 2016
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 30, 2019
• Results First Posted: May 30, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)