Effect of Phenazopyridine on Prolapse Surgery Voiding Trials (EPOV)
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ClinicalTrials.gov Identifier: NCT03065075 |
Recruitment Status :
Completed
First Posted : February 27, 2017
Results First Posted : March 26, 2019
Last Update Posted : April 16, 2019
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Tracking Information | |||||||
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First Submitted Date ICMJE | February 10, 2017 | ||||||
First Posted Date ICMJE | February 27, 2017 | ||||||
Results First Submitted Date ICMJE | January 25, 2019 | ||||||
Results First Posted Date ICMJE | March 26, 2019 | ||||||
Last Update Posted Date | April 16, 2019 | ||||||
Actual Study Start Date ICMJE | February 1, 2017 | ||||||
Actual Primary Completion Date | August 28, 2018 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) [ Time Frame: postoperative day 1 ] Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.
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Original Primary Outcome Measures ICMJE |
Void trial outcome: Rate of postoperative urinary retention after pelvic organ prolapse surgery [ Time Frame: 1 day ] We will measure the rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by the result of the void trial.
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Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures |
Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) [ Time Frame: postoperative day 1 ] Rate of postoperative urinary retention after pelvic organ prolapse surgery as determined by those who failed a standardized void trial. A successful void trial is defined as a postvoid residual of less than half of the voided volume.
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Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Effect of Phenazopyridine on Prolapse Surgery Voiding Trials | ||||||
Official Title ICMJE | Effect of Phenazopyridine on Prolapse Surgery Voiding Trials | ||||||
Brief Summary | To determine if phenazopyridine reduces the rate of postoperative urinary retention after pelvic organ prolapse surgery. | ||||||
Detailed 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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Urinary Retention Postoperative | ||||||
Intervention ICMJE | Drug: Phenazopyridine
Phenazopyridine 200 mg on morning of postoperative day 1
Other Name: Pyridium
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Study Arms ICMJE |
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Publications * | Sierra T, Taylor DL, Leung K, Hall CD, Flynn MK. The Effect of Phenazopyridine on Immediate Postoperative Voiding After Prolapse Surgery: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):85-89. doi: 10.1097/SPV.0000000000000737. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
152 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | February 28, 2019 | ||||||
Actual Primary Completion Date | August 28, 2018 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03065075 | ||||||
Other Study ID Numbers ICMJE | H00012082 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Michael Flynn, University of Massachusetts, Worcester | ||||||
Original Responsible Party | Tania Sierra, University of Massachusetts, Worcester, Principal Investigator | ||||||
Current Study Sponsor ICMJE | University of Massachusetts, Worcester | ||||||
Original Study Sponsor ICMJE | Same as current | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | University of Massachusetts, Worcester | ||||||
Verification Date | April 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |