Trial Outcomes & Findings for Assessing Pyridium for Post-Sling Urinary Retention (NCT NCT03302936)
NCT ID: NCT03302936
Last Updated: 2019-10-29
Results Overview
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Day 1
Results posted on
2019-10-29
Participant Flow
Participant milestones
| Measure |
Pyridium Arm
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
|
Control Arm Vitamin B-6 as Placebo
Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
46
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Pyridium Arm
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
|
Control Arm Vitamin B-6 as Placebo
Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
4
|
Baseline Characteristics
Assessing Pyridium for Post-Sling Urinary Retention
Baseline characteristics by cohort
| Measure |
Pyridium Arm
n=46 Participants
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
|
Control Arm
n=45 Participants
No intervention in this group. Routine perioperative care.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=99 Participants
|
45 participants
n=107 Participants
|
91 participants
n=206 Participants
|
|
Menopausal status
|
22 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Tobacco user
|
7 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
History of abdominal or pelvic surgery
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Outcome measures
| Measure |
Pyridium Arm
n=46 Participants
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
Failed void trial, 16 participants or 34.5% in the phenazopyridine arm.
|
Control Arm
n=45 Participants
Vitamin B-6 as placebo. Routine perioperative care.
Failed void trial, 15 participants or 33.3% in the placebo arm.
|
|---|---|---|
|
Number of Participants Considered to Have Passed Their Voiding Trial
|
30 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: Day 1Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Outcome measures
| Measure |
Pyridium Arm
n=46 Participants
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
Failed void trial, 16 participants or 34.5% in the phenazopyridine arm.
|
Control Arm
n=45 Participants
Vitamin B-6 as placebo. Routine perioperative care.
Failed void trial, 15 participants or 33.3% in the placebo arm.
|
|---|---|---|
|
Incidence of Urinary Retention
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1: 6-8 hours after surgeryPain scale from 0-10. 0-being no pain, 10-being the most pain
Outcome measures
| Measure |
Pyridium Arm
n=46 Participants
Phenazopyridine 200mg tablet, once prior to surgery
Phenazopyridine: to be given preoperatively
Failed void trial, 16 participants or 34.5% in the phenazopyridine arm.
|
Control Arm
n=45 Participants
Vitamin B-6 as placebo. Routine perioperative care.
Failed void trial, 15 participants or 33.3% in the placebo arm.
|
|---|---|---|
|
Pain Scale
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 2.0 to 4.0
|
Adverse Events
Pyridium
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Annacecilia Peacher-Holderied
Icahn School of Medicine at Mount Sinai
Phone: 2104887216
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place