Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Urinary Retention Postoperative Clinical Trial

— EPOV  

Official title:

Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03065075
• Other study ID #: H00012082
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: April 2019
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: February 28, 2019
• Est. primary completion date: August 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prolapse
• Urinary Retention
• Urinary Retention Postoperative

Intervention

Drug:
• Phenazopyridine
Phenazopyridine 200 mg on morning of postoperative day 1

Locations

Country	Name	City	State
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED)	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
Primary	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