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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pyridium arm | Experimental | Phenazopyridine 200mg tablet, once prior to surgery |
|
| Control arm | No Intervention | No intervention in this group. Routine perioperative care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenazopyridine | Drug | to be given preoperatively |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Incidence of Urinary Retention | Incidence of participants that do not pass their voiding trial and go home with an indwelling foley | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scale | Pain scale from 0-10. 0-being no pain, 10-being the most pain | Day 1: 6-8 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Ascher-Walsh, M.D. | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pyridium Arm | Phenazopyridine 200mg tablet, once prior to surgery Phenazopyridine: to be given preoperatively |
| FG001 | Control Arm Vitamin B-6 as Placebo | Vitamin B-6 50mg given once prior to surgery as placebo. Routine perioperative care. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pyridium Arm | Phenazopyridine 200mg tablet, once prior to surgery Phenazopyridine: to be given preoperatively |
| BG001 | Control Arm | No intervention in this group. Routine perioperative care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 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. | Posted | Count of Participants | Participants | Day 1 |
|
Through day of surgery
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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 | Pyridium | Phenazopyridine 200mg tablet, once prior to surgery | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annacecilia Peacher-Holderied | Icahn School of Medicine at Mount Sinai | 2104887216 | apeacher4@gmail.com |
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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 | Sep 28, 2017 | Sep 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Menopausal status | Count of Participants | Participants |
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| Tobacco user | Count of Participants | Participants |
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| History of abdominal or pelvic surgery | Count of Participants | Participants |
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|
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| Primary | Incidence of Urinary Retention | Incidence of participants that do not pass their voiding trial and go home with an indwelling foley | Posted | Count of Participants | Participants | Day 1 |
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| Secondary | Pain Scale | Pain scale from 0-10. 0-being no pain, 10-being the most pain | Posted | Median | Inter-Quartile Range | score on a scale | Day 1: 6-8 hours after surgery |
|
|
|
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Placebo | Vitamin B-6 50mg given once prior to surgery as placebo. | 0 | 49 | 0 | 49 | 0 | 49 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |