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Analgesic

Phenazopyridine for Pain After Urodynamic Testing

Phase 4
Waitlist Available
Led By Elizabeth A Wilkinson, MD
Research Sponsored by University of South Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Be older than 18 years old
Must not have
Women who did not undergo urodynamic testing
Patient less than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 to 6 hours after testing
Awards & highlights

Summary

This trial aims to find out if taking phenazopyridine (AZO) during urodynamic testing can reduce the pain that patients feel after the testing.

Who is the study for?
This trial is for individuals experiencing pain (dysuria) after urodynamic testing, which checks how well the bladder, sphincters, and urethra hold and release urine. Specific eligibility criteria are not provided.
What is being tested?
The study tests if Phenazopyridine Hydrochloride (99.5 MG), commonly known as AZO, can reduce pain following urodynamic studies compared to usual care without this medication.
What are the potential side effects?
Potential side effects of Phenazopyridine may include headache, dizziness, stomach cramps, or an upset stomach. It might also cause a reddish-orange discoloration of the urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had urodynamic testing.
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I am under 18 years old.
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My kidney function is severely reduced.
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I have severe hepatitis.
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I have been diagnosed with fibromyalgia.
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I have a history of bladder pain.
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I do not speak English or Spanish.
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I have a known G6PD deficiency.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 to 6 hours after testing
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 to 6 hours after testing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing
Secondary study objectives
Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time
Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate
Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity
+14 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment1 Intervention
Patient to take two 99.5mg phenazopyridine hydrochloride (AZO) for a total of 199 mg by mouth once immediately prior to the start of urodynamic testing.
Group II: Control ArmActive Control1 Intervention
Patient to not receive any medication prior to the start of urodynamic testing.

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Who is running the clinical trial?

University of South FloridaLead Sponsor
422 Previous Clinical Trials
189,161 Total Patients Enrolled
Elizabeth A Wilkinson, MDPrincipal InvestigatorUniversity of South Florida
~44 spots leftby Jul 2025
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