Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
EPOV
1 other identifier
interventional
152
1 country
1
Brief Summary
To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedResults Posted
Study results publicly available
March 26, 2019
CompletedApril 16, 2019
April 1, 2019
1.6 years
February 10, 2017
January 25, 2019
April 5, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)
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.
postoperative day 1
Other Outcomes (1)
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED)
postoperative day 1
Study Arms (2)
Phenazopyridine
EXPERIMENTALParticipant is given Phenazopyridine 200mg on postoperative day 1
No Phenazopyridine
NO INTERVENTIONParticipant is not given Phenazopyridine on postoperative day 1
Interventions
Phenazopyridine 200 mg on morning of postoperative day 1
Eligibility Criteria
You may qualify if:
- Women undergoing overnight admission after prolapse surgery
You may not qualify if:
- Unable to provide consent
- Under 18 years of age
- Pregnant women
- Prisoners
- Using intermittent self-catheterization preoperatively
- Neurological disease or spinal cord injury resulting in voiding dysfunction
- Undergoing spinal or epidural anesthesia for the procedure
- Allergy to phenazopyridine
- Renal insufficiency
- Liver disease
- Intra-operative bladder injury necessitating use of prolonged indwelling Foley catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Massachusetts
Worcester, Massachusetts, 01605, United States
Related Publications (1)
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.
PMID: 31033527DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Tania Sierra
- Organization
- University of Massachusetts
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Flynn, MD
UMass Worcester
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 27, 2017
Study Start
February 1, 2017
Primary Completion
August 28, 2018
Study Completion
February 28, 2019
Last Updated
April 16, 2019
Results First Posted
March 26, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share