Clinical trial NCT06577493: Effectiveness of Phenazopyridine for Pain Following Urodynamics
Official title: Effectiveness of Phenazopyridine for Pain Following Urodynamics
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Pain After Urodynamic Testing
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized into experimental or control groups
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing
timeFrame: 4 to 6 hours after testing
Secondary outcomes:
measure: Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points.
timeFrame: baseline (immediately prior to testing), immediately after testing, 4 to 6 hours after testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - void time
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure
timeFrame: at time of testing
measure: Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume
timeFrame: at time of testing
measure: Number of patient communications
timeFrame: Per single participant (24 hours after completion of UDS testing)
measure: Would patients repeat urodynamic testing
timeFrame: 4 to 6 hours after testing
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida South Tampa Center
state: Florida
Study officials:
affiliation: University of South Florida
name: Elizabeth A Wilkinson, MD
role: PRINCIPAL_INVESTIGATOR
References: