Trial Outcomes & Findings for Phenazopyridine for Confirmation of Ureteral Patency (NCT NCT02424149)
NCT ID: NCT02424149
Last Updated: 2016-12-05
Results Overview
Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
Day of surgery
Results posted on
2016-12-05
Participant Flow
Participant milestones
| Measure |
Control
No preoperative phenazopyridine
|
Phenazopyridine
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
52
|
52
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Control
No preoperative phenazopyridine
|
Phenazopyridine
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Overall Study
surgery cancelled
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Phenazopyridine for Confirmation of Ureteral Patency
Baseline characteristics by cohort
| Measure |
Control
n=52 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=52 Participants
Preoperative phenazopyridine
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.6 years
STANDARD_DEVIATION 11.3 • n=93 Participants
|
62.7 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
60.19 years
STANDARD_DEVIATION 10.89 • n=27 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
104 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=93 Participants
|
52 participants
n=4 Participants
|
104 participants
n=27 Participants
|
|
Charlson comorbidity index
|
1.96 scale score
STANDARD_DEVIATION 1.5 • n=93 Participants
|
2.31 scale score
STANDARD_DEVIATION 1.1 • n=4 Participants
|
2.13 scale score
STANDARD_DEVIATION 1.3 • n=27 Participants
|
|
Serum creatinine
|
0.66 mg/dL
STANDARD_DEVIATION 0.28 • n=93 Participants
|
0.63 mg/dL
STANDARD_DEVIATION 0.35 • n=4 Participants
|
0.65 mg/dL
STANDARD_DEVIATION 0.32 • n=27 Participants
|
|
History or prolapse surgery
|
7 participants
n=93 Participants
|
12 participants
n=4 Participants
|
19 participants
n=27 Participants
|
|
History of urinary tract surgery
|
6 participants
n=93 Participants
|
9 participants
n=4 Participants
|
15 participants
n=27 Participants
|
|
Surgical indication: prolapse
|
51 participants
n=93 Participants
|
49 participants
n=4 Participants
|
100 participants
n=27 Participants
|
|
Surgical indication: incontinence
|
21 participants
n=93 Participants
|
14 participants
n=4 Participants
|
35 participants
n=27 Participants
|
|
Stage II or greater prolapse: anterior
|
46 participants
n=93 Participants
|
46 participants
n=4 Participants
|
92 participants
n=27 Participants
|
|
Stage II or greater prolapse: apical
|
19 participants
n=93 Participants
|
24 participants
n=4 Participants
|
43 participants
n=27 Participants
|
|
Stage II or greater prolapse: posterior
|
38 participants
n=93 Participants
|
34 participants
n=4 Participants
|
72 participants
n=27 Participants
|
|
Surgical procedure performed: concomitant incontinence procedure
|
21 participants
n=93 Participants
|
21 participants
n=4 Participants
|
42 participants
n=27 Participants
|
|
Surgical procedure performed: prolapse repair without hysterectomy
|
16 participants
n=93 Participants
|
25 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
Surgical procedure performed: prolapse repair with vaginal hysterectomy
|
27 participants
n=93 Participants
|
18 participants
n=4 Participants
|
45 participants
n=27 Participants
|
|
Surgical procedure performed: prolapse repair with abdominal hysterectomy
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Surgical procedure performed: prolapse repair with laparoscopic hysterectomy
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day of surgeryTiming was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.
Outcome measures
| Measure |
Control
n=52 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=52 Participants
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
|
160 seconds
Standard Deviation 158
|
173 seconds
Standard Deviation 275
|
SECONDARY outcome
Timeframe: day of surgery (day 0)Surgeon response to the question: "I am confident that ureteral injury was ruled out in this patient" on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree
Outcome measures
| Measure |
Control
n=52 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=52 Participants
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Physician Confidence Measured by a Survey
|
4.6 units on a scale
Standard Deviation 0.49
|
4.5 units on a scale
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: day of surgery (day 0)this is a composite measure and will be reported as a single value for each arm as number of additional interventions
Outcome measures
| Measure |
Control
n=52 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=52 Participants
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR
|
4 interventions
|
3 interventions
|
SECONDARY outcome
Timeframe: post operative day 1Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.
Outcome measures
| Measure |
Control
n=52 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=52 Participants
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Post-operative Urethral Discomfort Measured by Pain Scales
|
2.3 units on a scale
Standard Deviation 2.8
|
2.1 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Day of hospital dischargePopulation: For this outcome, 96 participants were analyzed. Of the 104 participants that completed the study, only 96 underwent a trial of void.
Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.
Outcome measures
| Measure |
Control
n=49 Participants
No preoperative phenazopyridine
|
Phenazopyridine
n=47 Participants
Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
|
|---|---|---|
|
Trial of Void Results
|
19 participants who failed trial of void
|
9 participants who failed trial of void
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Phenazopyridine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place