Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (EPOV)

• ClinicalTrials.gov Identifier: NCT03065075
• Recruitment Status: Completed
• First Posted: February 27, 2017
• Results First Posted: March 26, 2019
• Last Update Posted: April 16, 2019
• Sponsor: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Michael Flynn, University of Massachusetts, Worcester

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urinary Retention Postoperative
• Intervention: Drug: Phenazopyridine
• Enrollment: 152

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Phenazopyridine on POD1	No Intervention on POD1
Arm/Group Description	Participant is given Phenazopyridine 200 mg on postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis: 1 had a bowel injury re-operation that precluded performing a void trial; 1 intraoperative cystotomy that precluded performing a void trial; 2 were using Foley catheters preoperatively, which was part of the exclusion criteria 72 subjects in the intent-to-treat analysis 3 did not receive the intervention:; 1 was too nauseous; 1 was erroneously missed; 1 refused 69 subjects in the as-treated analysis	Subject is not given Phenazopyridine on postoperative day 1 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis: 1 intraoperative cystotomy that precluded performing a void trial; 1 had spinal anesthesia, which was part of the exclusion criteria 74 subjects in the intent-to-treat analysis 3 cross-overs were brought in from the intervention arm because they did not receive the medication 77 subjects in the as-treated analysis
Period Title: Overall Study
Started	76	76
Intent-to-treat Analysis	72	74
As-treated Analysis	69	77
Completed	76	76
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Phenazopyridine	No Phenazopyridine	Total
Arm/Group Description		Participant is given Phenazopyridine on morning of postoperative day 1	Participant is not given Phenazopyridine on morning of postoperative day 1	Total of all reporting groups
Overall Number of Baseline Participants		76	76	152
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	76 participants	76 participants	152 participants
		61.4 (12.8)	60.9 (13.5)	61.2 (13.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	76 participants	76 participants	152 participants
	Female	76 100.0%	76 100.0%	152 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	76 participants	76 participants	152 participants
White		61 80.3%	59 77.6%	120 78.9%
Non-white		14 18.4%	17 22.4%	31 20.4%
Declined to answer		1 1.3%	0 0.0%	1 0.7%
Concomitant hysterectomy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	76 participants	76 participants	152 participants
		59 77.6%	62 81.6%	121 79.6%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)
Description	Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.
Time Frame	postoperative day 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat analysis

Arm/Group Title	Phenazopyridine	No Phenazopyridine
Arm/Group Description:	Participant is given Phenazopyridine on morning of postoperative day 1	Participant is not given Phenazopyridine on morning of postoperative day 1
Overall Number of Participants Analyzed	72	74
Measure Type: Count of Participants; Unit of Measure: Participants
	30 41.7%	25 33.8%

2. Other Pre-specified Outcome

Title	Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED)
Description	Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.
Time Frame	postoperative day 1

Outcome Measure Data

Analysis Population Description

As-treated analysis

Arm/Group Title	Phenazopyridine	No Phenazopyridine
Arm/Group Description:	Participant is given Phenazopyridine on morning of postoperative day 1	Participant is not given Phenazopyridine on morning of postoperative day 1
Overall Number of Participants Analyzed	69	77
Measure Type: Count of Participants; Unit of Measure: Participants
	28 40.6%	27 35.1%

Adverse Events

Time Frame	6 weeks
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Phenazopyridine		No Phenazopyridine
Arm/Group Description	Participant is given Phenazopyridine Phenazopyridine: Phenazopyridine on morning of postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis: 1 had a bowel injury re-operation that precluded performing a void trial; 1 intraoperative cystotomy that precluded performing a void trial; 2 were using Foley catheters preoperatively, which was part of the exclusion criteria 72 subjects in the intent-to-treat analysis 3 did not receive the intervention:; 1 was too nauseous; 1 was erroneously missed; 1 refused 69 subjects in the as-treated analysis		Participant is not given Phenazopyridine 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis: 1 intraoperative cystotomy that precluded performing a void trial; 1 had spinal anesthesia, which was part of the exclusion criteria 74 subjects in the intent-to-treat analysis 3 cross-overs were brought in from the intervention arm because they did not receive the medication 77 subjects in the as-treated analysis
All-Cause Mortality
	Phenazopyridine		No Phenazopyridine
	Affected / at Risk (%)		Affected / at Risk (%)
Total	1/76 (1.32%)		0/76 (0.00%)
Serious Adverse Events
	Phenazopyridine		No Phenazopyridine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/76 (1.32%)		0/76 (0.00%)
Gastrointestinal disorders
Bowel injury re-operation * [1]	1/76 (1.32%)	1	0/76 (0.00%)	0
* Indicates events were collected by non-systematic assessment; [1] Re-operation and ICU admission for bowel injury during prolapse surgery
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Phenazopyridine		No Phenazopyridine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/76 (11.84%)		14/76 (18.42%)
Infections and infestations
Urinary tract infection * [1]	9/76 (11.84%)	9	14/76 (18.42%)	14
* Indicates events were collected by non-systematic assessment; [1] A positive urine culture, urinalysis, or antibiotic treatment within 6 weeks postoperatively constituted a UTI.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Tania Sierra
• Organization: University of Massachusetts
• Phone: 508-334-9840
• EMail: tania.sierra@umassmemorial.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sierra T, Taylor DL, Leung K, Hall CD, Flynn MK. The Effect of Phenazopyridine on Immediate Postoperative Voiding After Prolapse Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):85-89. doi: 10.1097/SPV.0000000000000737.

• Responsible Party: Michael Flynn, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT03065075
• Other Study ID Numbers: H00012082
• First Submitted: February 10, 2017
• First Posted: February 27, 2017
• Results First Submitted: January 25, 2019
• Results First Posted: March 26, 2019
• Last Update Posted: April 16, 2019