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Evaluation of Ureteral Patency in the Post-indigo Carmine Era

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ClinicalTrials.gov Identifier: NCT02677623
Recruitment Status : Completed
First Posted : February 9, 2016
Results First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

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.


Condition or disease Intervention/treatment Phase
Ureteral Patency Drug: Pyridium Drug: Sodium Fluorescein Drug: Mannitol Other: Normal Saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Study Start Date : March 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Carmine

Arm Intervention/treatment
Experimental: A- Pyridium
  • 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
Experimental: B- Sodium Fluorescein
  • 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
Experimental: C- Mannitol
  • 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
Experimental: Control- Normal saline
  • Method of administration: irrigant during cystoscopy
  • Dose: 300cc
  • Known adverse events: no known significant adverse events
  • Contraindications: none
Other: Normal Saline



Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Intraoperative ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Planned cystoscopy

Exclusion Criteria:

  1. Women who are pregnant
  2. Women with contraindications to pyridium, sodium fluorescein or mannitol:

    1. Intra-operative administration of nitric oxide, prilocaine and sodium nitrite
    2. Anuria
    3. Women with creatinine greater than 1 or Cr Cl < 50ml/minute
    4. Known allergy to pyridium, sodium fluorescein or mannitol.
  3. Women with a known urologic anatomical anomaly

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677623


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Cara Grimes, MD Columbia University

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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02677623     History of Changes
Other Study ID Numbers: AAAP3450
First Posted: February 9, 2016    Key Record Dates
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs