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

Completed · Phase 3 · Has a placebo group

Conditions studied: Dysfunctional Voiding, Postoperative Pain

In brief

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

Key facts

Study ID

NCT02806713

Run by

University of Massachusetts, Worcester

People needed

92

Starts

2016-02-01

Expected to finish

2017-08-01

Last updated by the study team

2019-02-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Umass Memorial — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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