A Phase 4 interventional study of Phenazopyridine in Urinary Retention, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-29.
Sponsored by Icahn School of Medicine at Mount Sinai · Phase 4, Interventional, and Prevention
There has been preliminary data showing that pyridium can decrease the risk of difficulty urinating after midurethral sling. This study is designed to have two groups of patients. One group will receive pyridium pre-operatively, while the other group will have routine preoperative care. Both groups will have their bladder tested prior to going home. It will be evaluated if there is a difference in the difficulty to urinate post-operatively in both groups.
This is a prospective randomized controlled trial. It will have two arms with 48 patients in each arm, a total of 98 patients. Patients will be randomized with a block randomization schedule generated by computerized random numbers using a 1:1 allocation to pyridium and routine perioperative care. The study is powered to see a difference in incidence of urinary retention after midurethral sling using 25% as the historic control for our institution. Statistical sample size was based on a decrease in incidence to 5% in the pyridium arm. This is with 80% power and alpha 0.05. After the patient's surgery, including a midurethral sling, the patient will have an active voiding trial performed as described by Pulvino et al. The patient's bladder will be backfilled with 300cc of sterile saline. If the patient cannot tolerate 300cc, the patient will be filled to maximum capacity. The patient will be allowed 20 minutes to void. The patient must void greater than two thirds the volume that was instilled in the bladder to consider it a passed voiding trial. The timing of the voiding trial will be at the discretion of the surgeon, accounting for factors such as complexity of concomitant surgery, the patient being alert, ambulating, with tolerable pain.
241 studies on the registry are indexed under Urinary Retention; 44 are open to participants now.
This study's enrollment of 98 is close to the median of 90 across 187 interventional studies indexed under Urinary Retention.
Browse Urinary Retention studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 776 studies on the registry; 176 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 83 (66%) have results posted.
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Exclusion Criteria:
Phenazopyridine 200mg tablet, once prior to surgery
Drug: Phenazopyridine
No intervention in this group. Routine perioperative care.
to be given preoperatively
Also known as: Pyridium
Number of Participants Considered to Have Passed Their Voiding Trial
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
Time frame: Day 1
Incidence of Urinary Retention
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
Time frame: Day 1
Pain Scale
Pain scale from 0-10. 0-being no pain, 10-being the most pain
Time frame: Day 1: 6-8 hours after surgery
| Milestone | Pyridium Arm | Control Arm Vitamin B-6 as Placebo |
|---|---|---|
| Started | 49 | 49 |
| Completed | 46 | 45 |
| Not completed | 3 | 4 |
| Withdrew: Protocol violation | 3 | 4 |
Pyridium affect - A patient's bladder is backfilled with water prior to having foley removed. If they can void 200cc of 300cc instilled in the bladder, they are considered to have past their voiding trial.
| Participants | Pyridium Arm | Control Arm |
|---|---|---|
| Number of Participants Considered to Have Passed Their Voiding Trial | 30 | 30 |
Incidence of participants that do not pass their voiding trial and go home with an indwelling foley
| Participants | Urinary Retention in Pyridium | Urinary Retention in Placebo |
|---|---|---|
| Incidence of Urinary Retention | 16 | 15 |
Pain scale from 0-10. 0-being no pain, 10-being the most pain
| score on a scale | Pain Scale in Pyridium Arm | Pain Scale in Placebo Arm |
|---|---|---|
| Pain Scale | 3 (1 to 4) | 3 (2 to 4) |
Collected over Through day of surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pyridium | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Placebo | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Categorical(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 29 | 63 |
| >=65 years | 12 | 16 | 28 |
| Sex: Female, Male(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| Female | 46 | 45 | 91 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| Hispanic or Latino | 15 | 13 | 28 |
| Not Hispanic or Latino | 31 | 32 | 63 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 5 | 6 |
| White | 29 | 24 | 53 |
| More than one race | 15 | 13 | 28 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| United States | 46 | 45 | 91 |
| Menopausal status(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 22 | 28 | 50 |
| Tobacco user(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 7 | 0 | 7 |
| History of abdominal or pelvic surgery(Participants) | Pyridium Arm | Control Arm | Total |
|---|---|---|---|
| Count of participants | 13 | 9 | 22 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Jul 2019, 20 months.
Results were first posted in Oct 2019, 3 months after primary completion.
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Studies of the drug tested here: Phenazopyridine
Icahn School of Medicine at Mount Sinai →