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Clinical Trials/NCT06577493
NCT06577493RecruitingPhase 4

Effectiveness of Phenazopyridine for Pain Following Urodynamics

University of South Florida1 site in 1 country66 target enrollmentStarted: December 17, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 4
Status
Recruiting
Enrollment
66
Locations
1
Primary Endpoint
Difference in pain scores, as measured by visual analog scale between study groups at 4 to 6 hours after urodynamic testing
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 99 Years (Adult, Older Adult)
Sex
Female
Accepts 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

Arms & Interventions

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.

Intervention: Phenazopyridine Hydrochloride 99.5 MG (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Difference in Urodynamic voiding parameters between experimental group and known normal values - first sensation(at time of testing)
  • 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)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - capacity(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - first desire(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - strong desire(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - max flow rate(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - UDS procedure length time(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - voided volume(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - valsalva leak point pressure(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - void time(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - average flow rate(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - post void residual volume(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - flow time(at time of testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - max detrusor pressure(at time of testing)
  • Number of patient communications(Per single participant (24 hours after completion of UDS testing))
  • Would patients repeat urodynamic testing(4 to 6 hours after testing)
  • Difference in Urodynamic voiding parameters between experimental group and known normal values - time to max flow(at time of testing)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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