Pain After Urodynamic TestingPhase 4NCT06577493
Effectiveness of Phenazopyridine for Pain Following Urodynamics
A Phase 4 study testing Phenazopyridine Hydrochloride 99.5 MG in people with Pain After Urodynamic Testing, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain After Urodynamic Testing
- What is being tested?
- Phenazopyridine Hydrochloride 99.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to 1 Jul 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- patients with known (noted in patient chart and verbally asked) G6PD deficiency
- history of fibromyalgia
- history of interstitial cystitis
- non English or Spanish speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Florida South Tampa Center
Tampa, Florida, 33606
About this study
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.
- Conditions
- Pain After Urodynamic Testing
- Being tested
- Phenazopyridine Hydrochloride 99.5 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phenazopyridine Hydrochloride 99.5 MGDrug
Also called AZO
Experimental arm to take two 99.5 mg phenazopyridine hydrochloride by mouth for a total of 199mg immediately prior to start of urodynamic testing
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Phenazopyridine Hydrochloride 99.5 MG |
| Control Arm | No intervention | Patient to not receive any medication prior to the start of urodynamic testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 to 6 hours after testing
Secondary outcomes (17)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: at time of testing
Number of patient communications
Count the number of patient communications after the completion of study
Measured: 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
Measured: 4 to 6 hours after testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start17 Dec 2024
- Primary completion24 Nov 2025
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Urodynamic TestingStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into experimental or control groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Wilkinson, MD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577493
- Sponsor's protocol ID
- 007227
- Status last verified
- Apr 2026
- First submitted
- 25 Jul 2024
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Phenazopyridine for Pain Following Urodynamics
- ClinicalTrials.gov ID
- NCT06577493
- Acronym / sponsor ID
- 007227
- Conditions
- Pain After Urodynamic Testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 24 Nov 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized into experimental or control groups
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Phenazopyridine Hydrochloride 99.5 MGPatient 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phenazopyridine Hydrochloride 99.5 MGAlso: AZOExperimental arm to take two 99.5 mg phenazopyridine hydrochloride by mouth for a total of 199mg immediately prior to start of urodynamic testing | Drug | Experimental Arm |
Primary outcome
Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing
Time frame: 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.
17 secondary outcomes
Difference in anxiety scores, as measured by visual analog scale between study groups at predetermined time points.
Time frame: 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
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - void time
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure
Time frame: at time of testing
Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume
Time frame: at time of testing
Number of patient communications
Time frame: Per single participant (24 hours after completion of UDS testing)
Would patients repeat urodynamic testing
Time frame: 4 to 6 hours after testing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A Wilkinson, MD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Phenazopyridine Hydrochloride 99.5 MG in people with Pain After Urodynamic Testing, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing (time frame: 4 to 6 hours after testing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.