Trial Outcomes & Findings for Evaluation of Ureteral Patency in the Post-indigo Carmine Era (NCT NCT02677623)
NCT ID: NCT02677623
Last Updated: 2019-05-30
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
140 participants
Primary outcome timeframe
Intraoperative
Results posted on
2019-05-30
Participant Flow
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.
Participant milestones
| Measure |
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
Pyridium
|
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
Sodium Fluorescein
|
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
Mannitol
|
Control- Normal Saline
* Method of administration: irrigant during cystoscopy
* Dose: 300cc
* Known adverse events: no known significant adverse events
* Contraindications: none
Normal Saline
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
33
|
32
|
32
|
33
|
|
Overall Study
COMPLETED
|
33
|
32
|
32
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Baseline characteristics by cohort
| Measure |
A- Pyridium
n=33 Participants
* 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
|
B- Sodium Fluorescein
n=32 Participants
* 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
|
C- Mannitol
n=32 Participants
* 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
|
Control- Normal Saline
n=33 Participants
* Method of administration: irrigant during cystoscopy
* Dose: 300cc
* Known adverse events: no known significant adverse events
* Contraindications: none
Normal Saline
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Mean age
|
52 years
STANDARD_DEVIATION 11 • n=39 Participants
|
48 years
STANDARD_DEVIATION 15 • n=41 Participants
|
50 years
STANDARD_DEVIATION 11 • n=35 Participants
|
52 years
STANDARD_DEVIATION 12 • n=31 Participants
|
NA years
STANDARD_DEVIATION NA • n=146 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=39 Participants
|
32 Participants
n=41 Participants
|
32 Participants
n=35 Participants
|
33 Participants
n=31 Participants
|
130 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
22 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
44 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
12 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
53 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
1 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: IntraoperativePopulation: 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.
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).
Outcome measures
| Measure |
A- Pyridium
n=33 Participants
* 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
|
B- Sodium Fluorescein
n=32 Participants
* 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
|
C- Mannitol
n=32 Participants
* 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
|
Control- Normal Saline
n=33 Participants
* Method of administration: irrigant during cystoscopy
* Dose: 300cc
* Known adverse events: no known significant adverse events
* Contraindications: none
Normal Saline
|
|---|---|---|---|---|
|
Visual Analog Scale (VAS)
|
48 score on a scale
Interval 0.0 to 83.0
|
20 score on a scale
Interval 0.0 to 82.0
|
0 score on a scale
Interval 0.0 to 44.0
|
28 score on a scale
Interval 3.0 to 96.0
|
Adverse Events
A- Pyridium
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
B- Sodium Fluorescein
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
C- Mannitol
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Control- Normal Saline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A- Pyridium
n=33 participants at risk
* 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
|
B- Sodium Fluorescein
n=32 participants at risk
* 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
|
C- Mannitol
n=32 participants at risk
* 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
|
Control- Normal Saline
n=33 participants at risk
* Method of administration: irrigant during cystoscopy
* Dose: 300cc
* Known adverse events: no known significant adverse events
* Contraindications: none
Normal Saline
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Transfusion
|
6.1%
2/33 • Number of events 2 • Adverse events were recorded intraoperatively, 23 hours postoperatively, and at the 2- to 6-week postoperative follow-up visit.
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).
|
3.1%
1/32 • Number of events 1 • Adverse events were recorded intraoperatively, 23 hours postoperatively, and at the 2- to 6-week postoperative follow-up visit.
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).
|
3.1%
1/32 • Number of events 1 • Adverse events were recorded intraoperatively, 23 hours postoperatively, and at the 2- to 6-week postoperative follow-up visit.
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).
|
3.0%
1/33 • Number of events 1 • Adverse events were recorded intraoperatively, 23 hours postoperatively, and at the 2- to 6-week postoperative follow-up visit.
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).
|
Additional Information
Nisha Philip, Clinical Research Manager
Columbia University
Phone: 212-305-4973
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place