Catheter-related Bladder Discomfort
Conditions
Keywords
Phenazopyrdine, post operative bladder catheritization, VAS scores, Bladder pain related to indwelling foley catheters., Bladder irritaion related to indwelling foley catheters.
Brief summary
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.
Detailed description
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.
Interventions
Phenazopyrdine HCl 200 mg q8h x 24
OTHERPlacebo
Placebo tablet administered q8 hours for 24 hours postop.
Sponsors
Loyola University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
1. Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products). 2. Known contraindications to phenazopyridine HCl: * Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease). * History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs). * Known glucose-6-phosphate dehydrogenase deficiency. 3. Simultaneous suprapubic catheterization. 4. Inability to take oral medication within 12 hours after surgery. 5. Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | 24 hours | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled from September 2008 through December 2009 at the 2 Loyola system hospitals.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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 | 129 |
| 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. | 129 |
| Total | 258 |
Baseline characteristics
| Characteristic | Active Agent Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 54 years | 53 years | 54 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 126 Participants | 129 Participants | 255 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 18 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 105 Participants | 103 Participants | 208 Participants |
| Sex/Gender, Customized Women | 129 participants | 129 participants | 258 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 112 | 0 / 107 |
| serious Total, serious adverse events | 0 / 112 | 0 / 107 |
Outcome results
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.
Time frame: 24 hours
Population: Per Protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Agent Group | Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | 0.95 centimeters | Standard Deviation 1.8 |
| Placebo Group | Reduction of Catheter-associated Discomfort During the Post-operative Period in the Gynecologic Patient Using Mean Visual Analogue Scale (VAS) Measurments | 0.97 centimeters | Standard Deviation 1.7 |
Comparison: The independent samples t-test was used to test the null hypothesis that the mean VAS score for the active treatment cohort (i.e., those receiving pyridium) was no different than the mean VAS score for those receiving placebo.p-value: 0.745t-test, 2 sided