NCT03065075: EPOV

Effect of Phenazopyridine on Prolapse Surgery Voiding Trials

Completed Phase 3 Results posted Last updated 16 April 2019

What this trial tests

Phase 3 trial testing Phenazopyridine in Urinary Retention Postoperative in 152 participants. Completed in 28 February 2019.

Timeline

1 February 2017

Primary endpoint
28 August 2018

28 February 2019

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	152
Start date	1 February 2017
Primary completion	28 August 2018
Estimated completion	28 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Phenazopyridine — full drug profile →

Conditions studied

• Urinary Retention Postoperative — all drugs for Urinary Retention Postoperative →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, female only, with Urinary Retention Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) Primary · 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.

Group	Value	95% CI
Phenazopyridine	30
No Phenazopyridine	25

Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) Secondary · 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.

Group	Value	95% CI
Phenazopyridine	28
No Phenazopyridine	27

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phenazopyridine

Serious: 1/76 (1%)

Deaths: 1/76

No Phenazopyridine

Serious: 0/76 (0%)

Deaths: 0/76

Serious adverse events (1 terms)

Reaction	System	Phenazopyridine	No Phenazopyridine
Bowel injury re-operation	Gastrointestinal disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Phenazopyridine	No Phenazopyridine
Urinary tract infection	Infections and infestations	—	—

Most-reported serious reactions: Bowel injury re-operation.

Data from ClinicalTrials.gov NCT03065075 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.