Phase 3 Completed N=92 Randomized Single-blind Treatment

The Effect of Oral PhenazopyrIdine on Perioperative Voiding After Mid-urethral sliNg (EPIPhANy Study)

Dysfunctional Voiding · Postoperative Pain

Source: ClinicalTrials.gov NCT02806713 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcomePrimary: Percentage of Participants With a Failed Voiding Trial — 35; 32; 9; 12 Participants

Summary

Randomized clinical trial using phenazopyridine to decrease voiding dysfunction after a retropubic midurethral sling operation.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Failed Voiding Trial	35; 32; 9; 12	—
SECONDARY Change in Participant-reported Pain From Pre to Post Procedure Using the Visual Analog Scale (VAS)	1.76; 1.21	—

Eligibility Criteria

Inclusion Criteria

Any female subjects scheduled to undergo Mid-Urethral Sling (MUS) through the UMass urogynecology service for incontinence.

Exclusion Criteria

Planned concurrent prolapse or other procedure besides cystoscopy
Using intermittent self catheterization preoperatively
Undergoing spinal anesthesia for the procedure
Known allergy to phenazopyridine (AKA Pyridium)
Renal insufficiency
Any condition or situation that in the attending physician's opinion would contra-indicate the use of phenazopyridine
Subjects not competent to give consent
Prisoners
Non-English speaking patients
Age <18
Pregnant patients
Contraindications to the use of IV methylene blue including
Patients with known hypersensitivity reactions
Severe renal insufficiency
Patients with G6PD deficiency

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02806713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.