Effectiveness of Phenazopyridine for Pain Following Urodynamics
NCT Number: NCT06577493
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Pain After Urodynamic Testing
Interventions: DRUG: Phenazopyridine Hydrochloride 99.5 MG
Sponsor: University of South Florida
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-09-15
Completion Date: 2025-07-01
Locations: University of South Florida South Tampa Center, Tampa, Florida, 33606, United States

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.

Primary Outcome Measures: Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic 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., 4 to 6 hours after testing
Secondary Outcome Measures: Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points., 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., baseline (immediately prior to testing), immediately after testing, 4 to 6 hours after testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (UDS procedure length time) recorded in minutes, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first sensation) measured in mL, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first desire) measured in mL, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (strong desire) measured in mL, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (capacity) measured in mL, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (valsalva leak point pressure) recorded in cmH20, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max flow rate) is measured in mL/second, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (voided volume) is measured in mL, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - void time, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (void time) is measured in minutes:seconds, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (flow time) is measured in minutes:seconds, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (average flow rate) is measured in mL/seconds, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (time to max flow) is measured in minutes:seconds, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max detrusor pressure) is measured in cm H20, at time of testing|Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume, Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (post void residual volume) is measured in mL, at time of testing|Number of patient communications, Count the number of patient communications after the completion of study, Per single participant (24 hours after completion of UDS testing)|Would patients repeat urodynamic 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, 4 to 6 hours after testing