CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial (CATH)

THE CAT(H) STUDY CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial A CREST 2010 Project

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.

Study Overview

• Status: Completed
• Conditions: Catheter-related Bladder Discomfort
• Intervention / Treatment: Drug: phenazopyridine HCl; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 258
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola Univeristy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Study Medication 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	Drug: phenazopyridine HCl; Phenazopyrdine HCl 200 mg q8h x 24; Other Names: Pyridium
Placebo Comparator: Placebo tablet 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.	Other: Placebo; Placebo tablet administered q8 hours for 24 hours postop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Loyola University
• Investigators: Principal Investigator: Linda Brubaker, MD, Loyola University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 9, 2008
• First Submitted That Met QC Criteria: October 10, 2008
• First Posted (Estimate): October 13, 2008

Study Record Updates

• Last Update Posted (Estimate): September 29, 2016
• Last Update Submitted That Met QC Criteria: August 22, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Phenazopyrdine; post operative bladder catheritization; VAS scores; Bladder pain related to indwelling foley catheters.; Bladder irritaion related to indwelling foley catheters.
• Other Study ID Numbers: 201073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED