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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03065075
Recruitment Status : Completed
First Posted : February 27, 2017
Results First Posted : March 26, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael Flynn, 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, 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.

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Study Type : Interventional  (Clinical Trial)
Actual 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
Actual Primary Completion Date : August 28, 2018
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phenazopyridine
Participant is given Phenazopyridine 200mg on postoperative day 1
Drug: Phenazopyridine
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



Primary Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT03065075


Locations
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United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Michael Flynn, MD UMass Worcester
  Study Documents (Full-Text)

Documents provided by Michael Flynn, University of Massachusetts, Worcester:
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Responsible Party: Michael Flynn, MD, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03065075    
Other Study ID Numbers: H00012082
First Posted: February 27, 2017    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Urinary Retention
Prolapse
Pathological Conditions, Anatomical
Urination Disorders
Urologic Diseases