Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (EPOV)

• 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: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Michael Flynn, University of Massachusetts, Worcester

Tracking Information

• First Submitted Date: February 10, 2017
• First Posted Date: February 27, 2017
• Results First Submitted Date: January 25, 2019
• Results First Posted Date: March 26, 2019
• Last Update Posted Date: April 16, 2019
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: August 28, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: 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: Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Urinary Retention Postoperative

Intervention

Drug: Phenazopyridine

Phenazopyridine 200 mg on morning of postoperative day 1

Other Name: Pyridium

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2017): 152
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 28, 2019
• Actual Primary Completion Date: August 28, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03065075
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Michael Flynn, University of Massachusetts, Worcester
• Study Sponsor: University of Massachusetts, Worcester
• Collaborators: Not Provided

Investigators

• Principal Investigator: Michael Flynn, MD; UMass Worcester

• PRS Account: University of Massachusetts, Worcester
• Verification Date: April 2019