66 Participants Needed

Phenazopyridine for Pain After Urodynamic Testing

EW
Overseen ByElizabeth Wilkinson, MD
Age: 18+
Sex: Female
Trial Phase: Phase 4
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether phenazopyridine, commonly known as AZO, can reduce pain after urodynamic testing, a procedure that assesses how well the bladder and urethra store and release urine. Participants will either take the medication or not before the test to determine its effect on pain levels. Individuals who require urodynamic testing and can read and write in English or Spanish may be suitable candidates. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for phenazopyridine?

Research has shown that the FDA approves phenazopyridine to alleviate symptoms like pain, burning, and urgency caused by urinary tract irritation, indicating its general safety for these uses. Studies have found that phenazopyridine may cause side effects such as an upset stomach, headache, or dizziness. However, these side effects are usually mild and resolve on their own. Phenazopyridine has been used successfully for many years to treat urinary discomfort, suggesting it is well-tolerated by most people. Always consult a healthcare provider to ensure it is suitable for individual needs.12345

Why are researchers enthusiastic about this study treatment?

Most treatments for pain after urodynamic testing typically don't involve medication beforehand, leaving patients to manage discomfort post-procedure. But phenazopyridine is unique because it's taken just before the test begins. This proactive approach aims to prevent discomfort right from the start, potentially offering immediate relief. Researchers are excited about phenazopyridine because it provides a new way to tackle pain by working as a local analgesic in the urinary tract, which is different from the usual reactive treatments. This could make a big difference for patients who undergo these tests, improving their overall experience and comfort.

What evidence suggests that phenazopyridine might be an effective treatment for pain after urodynamic testing?

Studies have shown that phenazopyridine reduces pain from urinary procedures. The FDA has approved it to relieve symptoms such as pain and burning during urination. Research indicates it provides quick pain relief after procedures similar to urodynamic testing. For example, one study found it effective for pain relief after cystoscopy, a similar urinary test. Phenazopyridine calms the lining of the urinary tract, lessening discomfort. In this trial, participants in the experimental arm will take phenazopyridine to evaluate its potential to reduce pain after urodynamic tests.12567

Who Is on the Research Team?

EA

Elizabeth A Wilkinson, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be able to read and write in English or Spanish
Ability to provide informed consent
I can fill out a pain or symptom scale.
See 1 more

Exclusion Criteria

Allergy to phenazopyridine
I have had a urinary tract infection in the last 2 weeks.
I have not had urodynamic testing.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo urodynamic testing with or without phenazopyridine administration

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain and anxiety levels after urodynamic testing

24 hours
Remote monitoring

What Are the Treatments Tested in This Trial?

Interventions

  • Phenazopyridine
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment1 Intervention
Group II: Control ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Citations

NCT06577493 | Effectiveness of Phenazopyridine for Pain ...The purpose of the study is to determine if taking phenazopyridine (AZO) at the time of urodynamic study testing will decrease pain experienced by patients ...
Effectiveness of Phenazopyridine for Pain Following ...The purpose of the study is to determine if taking phenazopyridine (AZO) at the time of urodynamic study testing will decrease pain experienced ...
Phenazopyridine for Pain After Urodynamic TestingPhenazopyridine is generally used for short-term relief of urinary tract pain, but it can have side effects like orange urine, stomach issues, ...
Phenazopyridine - StatPearls - NCBI Bookshelf - NIHPhenazopyridine is approved by the US Food and Drug Administration (FDA) to alleviate symptoms of dysuria, burning sensations, urgency, ...
A Randomized, Prospective, Placebo/Controlled Study for ...We conclude that phenazopyridine HCl is effective for early acute pain relief following cystoscopy without side effects, and it is safe when used in combination ...
Phenazopyridine (oral route) - Side effects & dosagePhenazopyridine is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract.
Phenazopyridine (Azo, Pyridium, and others) – Uses, Side ...Phenazopyridine is used to help reduce symptoms of a bladder infection, such as pain or burning. It does not help treat the infection.
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