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
|Condition or disease||Intervention/treatment||Phase|
|Urinary Retention Postoperative||Drug: Phenazopyridine||Phase 3|
Several tools can be used to evaluate for ureteral patency during urogynecologic procedures. Typically, surgeons use urine dyes such as methylene blue, indigotindisulfonate sodium, or phenazopyridine, with the latter being restricted to oral administration. However in June 2014, the two U.S. manufacturers of indigotindisulfonate sodium stopped producing the medication and there is no prospect that it will be returning soon. Phenazopyridine is an over-the-counter medication (Azo-Gesic, Baridium, Urinary Pain Relief) that has been used safely for decades as a bladder analgesic and taints the urine orange.
Over the past few months, increasing evidence suggests that phenazopyridine may reduce transient postoperative urinary retention. Transient urinary retention is common after urogynecologic surgery and is assessed postoperatively by performing a void trial (VT) prior to discharge. In a study designed to determine the time from administration of oral phenazopyridine to visualize dye from the ureters, Propst et al incidentally found that 38% of patients (19 of 49) failed postoperative VTs without phenazopyridine, but only 19% (9 of 47) failed with phenazopyridine, p=0.04. Most recently, a study by Duenas-Garcia et al designed to examine local anesthetics and urinary retention in subjects undergoing midurethral slings found that phenazopyridine decreased the VT failure rate from 30% to 8% (5). The investigators hypothesize that giving a dose of phenazopyridine the morning after surgery will significantly reduce the rate of postoperative urinary retention in women undergoing prolapse repair.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||152 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Phenazopyridine on Prolapse Surgery Voiding Trials|
|Actual Study Start Date :||February 1, 2017|
|Actual Primary Completion Date :||August 28, 2018|
|Actual Study Completion Date :||February 28, 2019|
Participant is given Phenazopyridine 200mg on postoperative day 1
Phenazopyridine 200 mg on morning of postoperative day 1
Other Name: Pyridium
No Intervention: No Phenazopyridine
Participant is not given Phenazopyridine on postoperative day 1
- Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) [ Time Frame: postoperative day 1 ]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.
- Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) [ Time Frame: postoperative day 1 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03065075
|United States, Massachusetts|
|University of Massachusetts|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Michael Flynn, MD||UMass Worcester|