Effect of Phenazopyridine on Prolapse Surgery Voiding Trials
| Status: | Completed |
|---|---|
| Conditions: | Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/28/2019 |
| Start Date: | February 1, 2017 |
| End Date: | February 28, 2019 |
To determine if phenazopyridine reduces the rate of postoperative urinary retention after
pelvic organ prolapse surgery.
pelvic organ prolapse surgery.
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.
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.
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
We found this trial at
1
site
Worcester, Massachusetts 01655
Principal Investigator: Michael Flynn, MD
Phone: 508-334-9840
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