Phenazopyridine for Pain After Urodynamic Testing

Overseen By Elizabeth Wilkinson, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: University of South Florida

Disqualifiers: Renal insufficiency, Hepatitis, G6PD deficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

66 Participants Needed

Trial Summary

What is the purpose of this trial?

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 after undergoing urodynamic testing.

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 data supports the effectiveness of the drug phenazopyridine for pain relief after urodynamic testing?

Phenazopyridine is known to provide pain relief by acting on the bladder lining, which can help reduce discomfort in conditions like cystitis and bladder pain syndrome. It has been shown to have a local analgesic effect, which may help alleviate pain during and after procedures like cystoscopy. ^{1 2 3 4 5}

Is phenazopyridine generally safe for humans?

Phenazopyridine is generally used for short-term relief of urinary tract pain, but it can have side effects like orange urine, stomach issues, and rare serious effects like skin ulcers, blood problems, and kidney issues. Long-term use, especially in cancer patients, may increase the risk of adverse reactions. ^{1 2 3 4 6}

How is the drug phenazopyridine unique for pain after urodynamic testing?

Phenazopyridine is unique because it acts directly on the bladder lining to provide local pain relief, unlike other treatments that may work systemically (throughout the body). It is specifically used for short-term relief of bladder pain and discomfort, making it different from other pain relief options that might not target the bladder directly. ^{1 2 3 4 5}

Research Team

Elizabeth A Wilkinson, MD

Principal Investigator

University of South Florida

Eligibility Criteria

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.

Exclusion Criteria

Allergy to phenazopyridine

I have had a urinary tract infection in the last 2 weeks.

I have not had urodynamic testing.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Experimental Arm Experimental Treatment 1 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 Arm Active Control 1 Intervention

Patient to not receive any medication prior to the start of urodynamic testing.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Safety analysis of long-term phenazopyridine use for radiation cystitis. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Inhibition of TRPM8 by the urinary tract analgesic drug phenazopyridine. [2023]

3. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study]. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Effects of phenazopyridine on rat bladder primary afferent activity, and comparison with lidocaine and acetaminophen. [2022]

5. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Influence of phenazopyridine on the well-being of patients during and after cystoscopy]. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Skin ulcers as a complication of short-term use of phenazopyridine in an old man: A case report. [2022]