Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

NCT ID: NCT03065075

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-02-28

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.

Conditions

Urinary Retention Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phenazopyridine

Participant is given Phenazopyridine 200mg on postoperative day 1

Group Type: EXPERIMENTAL

Phenazopyridine

Intervention Type: DRUG

Phenazopyridine 200 mg on morning of postoperative day 1

No Phenazopyridine

Participant is not given Phenazopyridine on postoperative day 1

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phenazopyridine

Phenazopyridine 200 mg on morning of postoperative day 1

Intervention Type: DRUG

Other Intervention Names

Pyridium

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Michael Flynn

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Flynn, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Worcester

Locations

University of Massachusetts

Worcester, Massachusetts, United States

Countries

United States

References

Sierra T, Taylor DL, Leung K, Hall CD, Flynn MK. The Effect of Phenazopyridine on Immediate Postoperative Voiding After Prolapse Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):85-89. doi: 10.1097/SPV.0000000000000737.

Reference Type: DERIVED

PMID: 31033527 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H00012082

Identifier Type: -

Identifier Source: org_study_id