Effectiveness of Phenazopyridine for Pain Following Urodynamics
- Conditions
- Pain After Urodynamic Testing
- Interventions
- Registration Number
- NCT06577493
- Lead Sponsor
- University of South Florida
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 66
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Arm Phenazopyridine Hydrochloride 99.5 MG 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.
- Primary Outcome Measures
Name Time Method Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic 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 pain and higher scores indicating greater pain.
- Secondary Outcome Measures
Name Time Method Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first sensation) measured in mL
Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points. 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.
Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (capacity) measured in mL
Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (first desire) measured in mL
Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (strong desire) measured in mL
Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max flow rate) is measured in mL/second
Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (UDS procedure length time) recorded in minutes
Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (voided volume) is measured in mL
Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (average flow rate) is measured in mL/seconds
Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (valsalva leak point pressure) recorded in cmH20
Difference in Urodynamic voiding parameters between experimental group and known normal values - void time at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (void time) is measured in minutes:seconds
Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (post void residual volume) is measured in mL
Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (flow time) is measured in minutes:seconds
Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure at time of testing Determine if preprocedural phenazopyridine has any change on normal urodynamic voiding parameters (max detrusor pressure) is measured in cm H20
Number of patient communications Per single participant (24 hours after completion of UDS testing) Count the number of patient communications after the completion of study
Would patients repeat urodynamic testing 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
Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow 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
Trial Locations
- Locations (1)
University of South Florida South Tampa Center
🇺🇸Tampa, Florida, United States