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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Ureteral Patency
Interventions Drug: Pyridium
Drug: Sodium Fluorescein
Drug: Mannitol
Other: Normal Saline
Enrollment 140
Recruitment Details  
Pre-assignment Details 10 consented subjects were excluded prior to randomization. 8 had completed their surgery during a period of study suspension and 2 ended up not proceeding with surgery.
Arm/Group Title A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Hide Arm/Group Description
  • 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

Pyridium

  • 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

Sodium Fluorescein

  • 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

Mannitol

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

Normal Saline

Period Title: Overall Study
Started 33 32 32 33
Completed 33 32 32 33
Not Completed 0 0 0 0
Arm/Group Title A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline Total
Hide Arm/Group Description
  • 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

Pyridium

  • 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

Sodium Fluorescein

  • 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

Mannitol

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

Normal Saline

Total of all reporting groups
Overall Number of Baseline Participants 33 32 32 33 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Mean age Number Analyzed 33 participants 32 participants 32 participants 33 participants 130 participants
52  (11) 48  (15) 50  (11) 52  (12) NA [1]   (NA)
[1]
Cannot confirm whether the data was simply not collected for a total mean calculation, or if data was collected but lost. The research team is no longer at Columbia and this information cannot be verified.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 32 participants 33 participants 130 participants
Female
33
 100.0%
32
 100.0%
32
 100.0%
33
 100.0%
130
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 32 participants 33 participants 130 participants
African American
4
  12.1%
6
  18.8%
8
  25.0%
4
  12.1%
22
  16.9%
Caucasian
15
  45.5%
7
  21.9%
9
  28.1%
13
  39.4%
44
  33.8%
Hispanic
12
  36.4%
15
  46.9%
13
  40.6%
13
  39.4%
53
  40.8%
Asian
1
   3.0%
0
   0.0%
1
   3.1%
3
   9.1%
5
   3.8%
Other or Unknown
1
   3.0%
4
  12.5%
1
   3.1%
0
   0.0%
6
   4.6%
1.Primary Outcome
Title Visual Analog Scale (VAS)
Hide Description 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).
Time Frame Intraoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Inclusion criteria stipulated women age >18 years who desired elective, scheduled gynecologic or urogynecologic surgery. Women were excluded if they were pregnant; had a known urologic anatomical anomaly; or had a history of adverse reaction or contraindication to use of phenazopyridine, sodium fluorescein, or mannitol.
Arm/Group Title A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Hide Arm/Group Description:
  • 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

Pyridium

  • 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

Sodium Fluorescein

  • 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

Mannitol

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

Normal Saline

Overall Number of Participants Analyzed 33 32 32 33
Median (Full Range)
Unit of Measure: score on a scale
48
(0 to 83)
20
(0 to 82)
0
(0 to 44)
28
(3 to 96)
Time Frame Adverse events were recorded intraoperatively, 23 hours postoperatively, and at the 2- to 6-week postoperative follow-up visit.
Adverse Event Reporting Description All patient medical records were reviewed for adverse events such as blood transfusion; patient report or provider identification of headache, dizziness, vertigo, stomach cramps, dysuria, polyuria, nausea, vomiting, skin flushing, rash, skin pigmentation, phlebitis, cardiovascular compromise, or skin or sclera discoloration; and abnormal lab values including renal failure ,anemia, and hepatitis , hyponatremia and urinary tract infection (UTI).
 
Arm/Group Title A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Hide Arm/Group Description
  • 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

Pyridium

  • 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

Sodium Fluorescein

  • 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

Mannitol

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

Normal Saline

All-Cause Mortality
A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/32 (0.00%)      0/32 (0.00%)      0/33 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/32 (0.00%)      0/32 (0.00%)      0/33 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A- Pyridium B- Sodium Fluorescein C- Mannitol Control- Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/33 (6.06%)      1/32 (3.13%)      1/32 (3.13%)      1/33 (3.03%)    
Blood and lymphatic system disorders         
Transfusion  [1]  2/33 (6.06%)  2 1/32 (3.13%)  1 1/32 (3.13%)  1 1/33 (3.03%)  1
Indicates events were collected by systematic assessment
[1]
Adverse events within 23 hours of surgery
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nisha Philip, Clinical Research Manager
Organization: Columbia University
Phone: 212-305-4973
EMail: np2173@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT02677623     History of Changes
Other Study ID Numbers: AAAP3450
First Submitted: February 4, 2016
First Posted: February 9, 2016
Results First Submitted: March 27, 2019
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019