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. Identifier: NCT03065075
Recruitment Status : Recruiting
First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Information provided by (Responsible Party):
Tania Sierra, University of Massachusetts, Worcester

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

Condition or disease Intervention/treatment Phase
Urinary Retention Postoperative Drug: Phenazopyridine Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phenazopyridine Drug: Phenazopyridine
Phenazopyridine on morning of postoperative day 1
No Intervention: No Phenazopyridine

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03065075

Contact: Tania Sierra, MD 508-334-9840
Contact: Michael Flynn, MD 508-334-9840

United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01605
Contact: Tania Sierra, MD    508-334-9840   
Principal Investigator: Michael Flynn, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester

Responsible Party: Tania Sierra, Principal Investigator, University of Massachusetts, Worcester Identifier: NCT03065075     History of Changes
Other Study ID Numbers: H00012082
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Urinary Retention
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases