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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

Tracking Information
First Submitted Date  ICMJE February 10, 2017
First Posted Date  ICMJE February 27, 2017
Results First Submitted Date  ICMJE January 25, 2019
Results First Posted Date  ICMJE March 26, 2019
Last Update Posted Date April 16, 2019
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2019)
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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
Official Title  ICMJE Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
Brief Summary To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Retention Postoperative
Intervention  ICMJE Drug: Phenazopyridine
Phenazopyridine 200 mg on morning of postoperative day 1
Other Name: Pyridium
Study Arms  ICMJE
  • Experimental: Phenazopyridine
    Participant is given Phenazopyridine 200mg on postoperative day 1
    Intervention: Drug: Phenazopyridine
  • No Intervention: No Phenazopyridine
    Participant is not given Phenazopyridine on postoperative day 1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2017)
152
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2019
Actual Primary Completion Date August 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03065075
Other Study ID Numbers  ICMJE H00012082
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michael Flynn, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Flynn, MD UMass Worcester
PRS Account University of Massachusetts, Worcester
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP