Urinary Retention Postoperative
Conditions
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.
Interventions
DRUGPhenazopyridine
Phenazopyridine 200 mg on morning of postoperative day 1
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Phenazopyridine Participant is given Phenazopyridine on morning of postoperative day 1 | 76 |
| No Phenazopyridine Participant is not given Phenazopyridine on morning of postoperative day 1 | 76 |
| Total | 152 |
Baseline characteristics
| Characteristic | Phenazopyridine | No Phenazopyridine | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 12.8 | 60.9 years STANDARD_DEVIATION 13.5 | 61.2 years STANDARD_DEVIATION 13.2 |
| Concomitant hysterectomy | 59 Participants | 62 Participants | 121 Participants |
| Race/Ethnicity, Customized Declined to answer | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-white | 14 Participants | 17 Participants | 31 Participants |
| Race/Ethnicity, Customized White | 61 Participants | 59 Participants | 120 Participants |
| Sex: Female, Male Female | 76 Participants | 76 Participants | 152 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 76 | 0 / 76 |
| other Total, other adverse events | 9 / 76 | 14 / 76 |
| serious Total, serious adverse events | 1 / 76 | 0 / 76 |
Outcome results
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.
Time frame: postoperative day 1
Population: Intent-to-treat analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phenazopyridine | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 30 Participants |
| No Phenazopyridine | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (INTENT-TO-TREAT) | 25 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.
Time frame: postoperative day 1
Population: As-treated analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phenazopyridine | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) | 28 Participants |
| No Phenazopyridine | Number of Participants With Postoperative Urinary Retention After Pelvic Organ Prolapse Surgery (AS-TREATED) | 27 Participants |