Pain After Urodynamic Testing
Conditions
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.
Interventions
DRUGPhenazopyridine 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
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Patients will be randomized into experimental or control groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 - 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 - 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 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 |
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElizabeth A Wilkinson, MD
University of South Florida
Outcome results
None listed