Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (EPOV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03065075|
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : February 27, 2017
|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, inditgotindisulfonate sodium, or phenazopyridine, with the latter being restricted to oral administration. However in June 2014, the two U.S. manufacturers of inditgotindisulfonate 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)|
|Estimated 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|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Phenazopyridine on morning of postoperative day 1
|No Intervention: No Phenazopyridine|
- Void trial outcome: Rate of postoperative urinary retention after pelvic organ prolapse surgery [ Time Frame: 1 day ]We will measure the rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by the result of the void trial.
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
|Contact: Tania Sierra, MDfirstname.lastname@example.org|
|Contact: Michael Flynn, MDemail@example.com|
|United States, Massachusetts|
|University of Massachusetts||Recruiting|
|Worcester, Massachusetts, United States, 01605|
|Contact: Tania Sierra, MD 508-334-9840 firstname.lastname@example.org|
|Principal Investigator: Michael Flynn, MD|