Trial Outcomes & Findings for The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study) (NCT NCT02806713)

Last Updated: 2019-02-05

Results Overview

Number of participants with a failed postoperative voiding trial. A failed voiding trial is defined as not voiding all urine in 20 minutes or voiding less than 1/3 of total volume (voided volume + post void residual). Patients will undergo voiding trial at same day surgery per the following protocol. Participants who do not pass the voiding trial the same day of their surgical procedure return to the clinic in 3 days to repeat it, following the same protocol described above.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

92 participants

Primary outcome timeframe

Postoperatively, up to 3 days after surgery

Results posted on

2019-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	no Phenazopyridine Patients not receiving phenazopyridine (standard of care) no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided	Phenazopyridine Patients receiving phenazopyridine Phenazopyridine
Overall Study STARTED	46	46
Overall Study COMPLETED	44	44
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	no Phenazopyridine Patients not receiving phenazopyridine (standard of care) no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided	Phenazopyridine Patients receiving phenazopyridine Phenazopyridine
Overall Study Urethral injury during procedure	1	0
Overall Study cancelled surgery	1	2

Baseline Characteristics

The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	no Phenazopyridine n=44 Participants Patients not receiving phenazopyridine (standard of care) no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided	Phenazopyridine n=44 Participants Patients receiving phenazopyridine Phenazopyridine	Total n=88 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.7 years n=5 Participants	49.7 years n=7 Participants	48.7 years n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	44 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	44 participants n=7 Participants	88 participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperatively, up to 3 days after surgery

Outcome measures

Outcome measures
Measure	no Phenazopyridine n=44 Participants Patients not receiving phenazopyridine (standard of care) no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided	Phenazopyridine n=44 Participants Patients receiving phenazopyridine Phenazopyridine
Percentage of Participants With a Failed Voiding Trial Passed the voiding trial	35 Participants	32 Participants
Percentage of Participants With a Failed Voiding Trial Failed a voiding trial	9 Participants	12 Participants

SECONDARY outcome

Timeframe: Preoperatively and then 2 to 3 hours after surgery

To determine if the phenazopyridine has an analgesic effect after the retropubic midurethral slings, participants will be asked to self-report pain intensity preoperatively and then postoperatively (2 to 3 hours post procedure) using the Visual Analog Scale (VAS). The scale of the VAS is from 0 meaning "no pain" to 10 indicating the "worst pain." The resulting change is measured as the difference between the self-reported preoperative pain score and the postoperative pain score.

Outcome measures

Outcome measures
Measure	no Phenazopyridine n=44 Participants Patients not receiving phenazopyridine (standard of care) no Phenazopyridine: Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided	Phenazopyridine n=44 Participants Patients receiving phenazopyridine Phenazopyridine
Change in Participant-reported Pain From Pre to Post Procedure Using the Visual Analog Scale (VAS)	1.76 score on a scale Standard Deviation 1.31	1.21 score on a scale Standard Deviation 1.2

Adverse Events

no Phenazopyridine

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

Michael K Flynn

University of Massachusetts UMass Memorial

Phone: (508) 856-5152

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place