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Completed

NCT Number: NCT03065075

Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Massachusetts

Worcester, Massachusetts, 01605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women undergoing overnight admission after prolapse surgery

Exclusion criteria

  • 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

Treatment and study plan

Phenazopyridine

Drug

Phenazopyridine 200 mg on morning of postoperative day 1

Other names: Pyridium

Primary outcomes

  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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Acronym: EPOV

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 27, 2017
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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