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
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Study Type | Interventional |
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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 |
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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:
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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:
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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 | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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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 |
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Number Analyzed | 76 participants | 76 participants | 152 participants | |
Female |
76 100.0%
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76 100.0%
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152 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 76 participants | 76 participants | 152 participants |
White |
61 80.3%
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59 77.6%
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120 78.9%
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Non-white |
14 18.4%
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17 22.4%
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31 20.4%
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Declined to answer |
1 1.3%
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0 0.0%
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1 0.7%
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Concomitant hysterectomy
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 76 participants | 76 participants | 152 participants | |
59 77.6%
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62 81.6%
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121 79.6%
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Name/Title: | Dr. Tania Sierra |
Organization: | University of Massachusetts |
Phone: | 508-334-9840 |
EMail: | tania.sierra@umassmemorial.org |
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 |