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To determine if phenazopyridine reduces the rate of postoperative urinary retention after 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenazopyridine | Experimental | Participant is given Phenazopyridine 200mg on postoperative day 1 |
|
| No Phenazopyridine | No Intervention | Participant is not given Phenazopyridine on postoperative day 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenazopyridine | Drug | Phenazopyridine 200 mg on morning of postoperative day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 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. | postoperative day 1 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) | 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. | postoperative day 1 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Flynn, MD | UMass Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts | Worcester | Massachusetts | 01605 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033527 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenazopyridine on POD1 | Participant is given Phenazopyridine 200 mg on postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis:
|
| FG001 | No Intervention on POD1 | Subject is not given Phenazopyridine on postoperative day 1 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenazopyridine | Participant is given Phenazopyridine on morning of postoperative day 1 |
| BG001 | No Phenazopyridine | Participant is not given Phenazopyridine on morning of postoperative day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 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. | Intent-to-treat analysis | Posted | Count of Participants | Participants | postoperative day 1 |
|
6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phenazopyridine | Participant is given Phenazopyridine Phenazopyridine: Phenazopyridine on morning of postoperative day 1 76 subjects were randomized into this arm 4 were removed from the intent-to-treat analysis:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bowel injury re-operation | Gastrointestinal disorders | Non-systematic Assessment | Re-operation and ICU admission for bowel injury during prolapse surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment | A positive urine culture, urinalysis, or antibiotic treatment within 6 weeks postoperatively constituted a UTI. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tania Sierra | University of Massachusetts | 508-334-9840 | tania.sierra@umassmemorial.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2017 | Feb 21, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Concomitant hysterectomy | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) | 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. | As-treated analysis | Posted | Count of Participants | Participants | postoperative day 1 |
|
|
|
| 1 |
| 76 |
| 1 |
| 76 |
| 9 |
| 76 |
| EG001 | No Phenazopyridine | Participant is not given Phenazopyridine 76 subjects were randomized into this arm 2 were removed from the intent-to-treat analysis:
| 0 | 76 | 0 | 76 | 14 | 76 |
|
|
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