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Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (EPOV)

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Phenazopyridine on POD1 No Intervention on POD1
Hide 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
Arm/Group Title Phenazopyridine No Phenazopyridine Total
Hide 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
Hide 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%
1.Primary Outcome
Title Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat analysis
Arm/Group Title Phenazopyridine No Phenazopyridine
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated analysis
Arm/Group Title Phenazopyridine No Phenazopyridine
Hide 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%
Time Frame 6 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Phenazopyridine No Phenazopyridine
Hide 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%)    
Hide 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
Hide 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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Tania Sierra
Organization: University of Massachusetts
Phone: 508-334-9840
EMail: tania.sierra@umassmemorial.org
Layout table for additonal information
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