Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

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

Detailed Description
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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.

Official Title
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Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Conditions
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Urinary Retention Postoperative

Intervention / Treatment
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* Drug: Phenazopyridine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phenazopyridine<br>Participant is given Phenazopyridine 200mg on postoperative day 1 | Drug: Phenazopyridine<br>* Phenazopyridine 200 mg on morning of postoperative day 1<br>* Other names: Pyridium;|
| No Intervention: No Phenazopyridine<br>Participant is not given Phenazopyridine on postoperative day 1 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 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. | postoperative day 1 |