Clinical Trials Logo

Clinical Trial Summary

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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03065075
Study type Interventional
Source University of Massachusetts, Worcester
Contact
Status Completed
Phase Phase 3
Start date February 1, 2017
Completion date February 28, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Active, not recruiting NCT04010656 - Optimization of Spontaneous Postoperative Trial of Void Among Women N/A
Recruiting NCT04597372 - Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery Phase 2
Recruiting NCT04707001 - Urinary Retention After Arthroplasty N/A
Terminated NCT05353400 - At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial N/A
Completed NCT03818321 - Urinary Track Infection Prevention After Urogynecological Surgery Phase 2
Recruiting NCT05020613 - Early and Late Removal of the Urinary Catheter After Rectum Resection N/A
Completed NCT03071211 - Catheter Management After Pelvic Reconstructive Surgery N/A
Not yet recruiting NCT06241703 - Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery N/A
Recruiting NCT05249192 - Immediate Versus Early (24-hours) Urinary Catheter Removal After Elective Minimally Invasive Colonic Resection N/A
Completed NCT04783012 - Patient Removal of Catheters After Urogynecologic Surgery N/A
Recruiting NCT04465578 - Incidence of Short-term Urinary Retention After Fascial Retropubic Sling: Prospective and Randomized Analysis. N/A
Recruiting NCT05108506 - Strict Need to Void After Same-day Discharge, Non-urogynecologic, Minimally Invasive Hysterectomy N/A
Enrolling by invitation NCT05887375 - Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery Phase 4
Recruiting NCT03808155 - Prevention of Postoperative Urinary Retention With Treatment of Tamsulosin 5 Days Prior to Lower Limb Arthroplasty Phase 4
Completed NCT04859660 - Pre-operative Tamsulosin and Time to Spontaneous Void After Hysterectomy Phase 2
Not yet recruiting NCT06262048 - Prevention of Post Operative Urinary Retention After Thoracic Surgery Trial Phase 2