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

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Massachusetts, Worcester

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Planned concurrent prolapse or other procedure besides cystoscopy

2. Using intermittent self catheterization preoperatively

3. Undergoing spinal anesthesia for the procedure

4. Known allergy to phenazopyridine (AKA Pyridium)

5. Renal insufficiency

6. Any condition or situation that in the attending physician's opinion would contra-indicate the use of phenazopyridine

7. Subjects not competent to give consent

8. Prisoners

9. Non-English speaking patients

10. Age <18

11. Pregnant patients

12. Contraindications to the use of IV methylene blue including

1. Patients with known hypersensitivity reactions

2. Severe renal insufficiency

3. Patients with G6PD deficiency