Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Phase 3

Completed

• Conditions: Urinary Retention Postoperative
• Interventions: Drug: Phenazopyridine

• Registration Number: NCT03065075
• Lead Sponsor: University of Massachusetts, Worcester

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 Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-10
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-02-27
• Primary Completion: 2018-08-28
• Results First Submitted: 2019-01-25
• Study Completion: 2019-02-28
• Results First Submitted QC: 2019-03-04
• Results First Posted: 2019-03-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-05
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

• Women undergoing overnight admission after prolapse surgery

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phenazopyridine	Phenazopyridine	Participant is given Phenazopyridine 200mg on postoperative day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT)	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.

Trial Locations

Locations (1)

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States