Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06577493

Effectiveness of Phenazopyridine for Pain Following Urodynamics

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Pain After Urodynamic Testing

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of South Florida South Tampa Center

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenazopyridine Hydrochloride 99.5 MG

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

Other names: AZO

Primary outcomes

  1. Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing

    Time frame: 4 to 6 hours after testing

    Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.

Secondary outcomes

  1. Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points.

    Time frame: baseline (immediately prior to testing), immediately after testing, 4 to 6 hours after testing

    Scores are measured on a 100mm VAS. The VAS ranges from 0 to 100 with 0 indicating no anxiety and higher scores indicating greater anxiety.

  2. Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (UDS procedure length time) recorded in minutes

  3. Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first sensation) measured in mL

  4. Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first desire) measured in mL

  5. Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (strong desire) measured in mL

  6. Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (capacity) measured in mL

  7. Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (valsalva leak point pressure) recorded in cmH20

  8. Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max flow rate) is measured in mL/second

  9. Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (voided volume) is measured in mL

  10. Difference in Urodynamic voiding parameters between experimental group and known normal values - void time

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (void time) is measured in minutes:seconds

  11. Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (flow time) is measured in minutes:seconds

  12. Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (average flow rate) is measured in mL/seconds

  13. Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (time to max flow) is measured in minutes:seconds

  14. Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max detrusor pressure) is measured in cm H20

  15. Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume

    Time frame: at time of testing

    Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (post void residual volume) is measured in mL

  16. Number of patient communications

    Time frame: Per single participant (24 hours after completion of UDS testing)

    Count the number of patient communications after the completion of study

  17. Would patients repeat urodynamic testing

    Time frame: 4 to 6 hours after testing

    Evaluate patients' willingness to undergo urodynamic testing again measured by a 1 to 5 likert scale with 1 being not at all likely and 5 being very likely

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 29, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.