Effectiveness of Phenazopyridine for Pain Following Urodynamics

NCT ID: NCT06577493

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-17
• Study Completion Date: 2025-07-01

Brief Summary

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.

Conditions

Pain After Urodynamic Testing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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 Type: EXPERIMENTAL

Phenazopyridine Hydrochloride 99.5 MG

Intervention Type: DRUG

Experimental arm to take two 99.5 mg phenazopyridine hydrochloride by mouth for a total of 199mg immediately prior to start of urodynamic testing

Control Arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phenazopyridine Hydrochloride 99.5 MG

Experimental arm to take two 99.5 mg phenazopyridine hydrochloride by mouth for a total of 199mg immediately prior to start of urodynamic testing

Intervention Type: DRUG

Other Intervention Names

AZO

Eligibility Criteria

Inclusion Criteria

• ability to provide informed consent
• ability to complete visual analog scale
• requiring urodynamic testing
• 18 years of age or older
• must be able to read and write in English or Spanish

Exclusion Criteria

• allergy to phenazopyridine
• a urinary tract infection in the prior 2 weeks
• women who did not undergo urodynamic testing
• patient less than 18 years old
• patients with known (noted in patient chart and verbally asked) severe renal insufficiency with GFR <50 mL/min,
• patients with known (noted in patient chart and verbally asked) severe hepatitis
• patients with known (noted in patient chart and verbally asked) G6PD deficiency
• history of fibromyalgia
• history of interstitial cystitis
• non English or Spanish speaking

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth A Wilkinson, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida South Tampa Center

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Wilkinson, MD

Role: CONTACT

wilkinsone@usf.edu

8139745638

Facility Contacts

Elizabeth Wilkinson, MD

Role: primary

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

007227

Identifier Type: -

Identifier Source: org_study_id