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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Arm | Experimental | 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. |
|
| Control Arm | No Intervention | Patient to not receive any medication prior to the start of urodynamic testing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Wilkinson, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida South Tampa Center | Tampa | Florida | 33606 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | Jul 19, 2024 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D010621 | Phenazopyridine |
| ID | Term |
|---|---|
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will be randomized into experimental or control groups
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| 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 |