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The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.
This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery.
Hypothesis and Aims:
We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a Foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo.
The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Medication Group | Active Comparator | Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first |
|
| Placebo tablet Group | Placebo Comparator | For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenazopyridine HCl | Drug | Phenazopyrdine HCl 200 mg q8h x 24 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts. | 24 hours |
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Inclusion Criteria:
1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.
Exclusion Criteria:
Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).
Known contraindications to phenazopyridine HCl:
Simultaneous suprapubic catheterization.
Inability to take oral medication within 12 hours after surgery.
Pregnant women.
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| Name | Affiliation | Role |
|---|---|---|
| Linda Brubaker, MD | Loyola University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loyola Univeristy Medical Center | Maywood | Illinois | 60153 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21376167 | Result | Anderson C, Chimhanda M, Sloan J, Galloway S, Sinacore J, Brubaker L. Phenazopyridine does not improve catheter discomfort following gynecologic surgery. Am J Obstet Gynecol. 2011 Mar;204(3):267.e1-3. doi: 10.1016/j.ajog.2010.12.045. |
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All enrolled patients were randomized to a group. Those patients who were enrolled but not included in statistical analysis was due to inconsistent collection of our primary outcome data. Nursing staff and house staff failed to collect VAS scores consistently.
Participants were enrolled from September 2008 through December 2009 at the 2 Loyola system hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group | For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. Blinding: The research pharmacist has facilitated the blinding by placing the active agent (200 mg tablets) into a solid colored capsule. She will make matching placebo capsules filled with lactose powder. To aid in blinding and avoid systemic administration of other dye agents for women in the placebo group, a small amount of orange dye will be placed in the Foley bag. This has been tested in the planning for this trial and is known effectively color the urine orange. |
| FG001 | Active Agent Group | Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Agent Group | Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24 |
| 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 | Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | The VAS measures bladder pain on a straight line from 0 to 10 in centimeters, where a mark of zero indicates no pain and a mark of 10 indicates worst possible pain. Mean VAS score was recorded for participants in the active treatment and placebo cohorts. | Per Protocol | Posted | Mean | Standard Deviation | centimeters | 24 hours |
|
Adverse events were recorded over the course of 24 hours during participants' hospitalization.
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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 | Active Agent Group | Participants that are randomized to the phenazopyridine HCl group will receive the study medication (200 mg of phenzopyridine HCl orally) after leaving the operating room. We anticipate the first dose to be given after the patient has left the recovery area. We will continue use of study medication until it has been given up to 24 hours after the first VAS collection or catheter removal, whichever occurs first phenazopyridine HCl: Phenazopyrdine HCl 200 mg q8h x 24 |
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One limitation of our study was inconsistent collection of our primary outcome data. Nursing staff and house staff failed to collect VAS scores consistently.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Brubaker | Loyola University Chicago | 708-216-3960 | lbrubaker@lumc.edu |
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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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| Placebo | Other | Placebo tablet administered q8 hours for 24 hours postop. |
|
| BG001 | Placebo Group | For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. Placebo: Placebo tablet administered q8 hours for 24 hours postop. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Placebo Group | For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. Placebo: Placebo tablet administered q8 hours for 24 hours postop. |
|
|
|
| 0 |
| 112 |
| 0 |
| 112 |
| EG001 | Placebo Group | For participants randomized to the placebo group will follow the same dosing schedule for the study medication, although they will receive an inert placebo tablet. Placebo: Placebo tablet administered q8 hours for 24 hours postop. | 0 | 107 | 0 | 107 |
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