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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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 to 6 hours after testing

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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.

0 / 9Eligibility criteria met