N/A
Completed N=107
Phenazopyridine for Confirmation of Ureteral Patency
Cystoscopy
Source: ClinicalTrials.gov NCT02424149 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room — 160; 173 seconds — p=0.77
Summary
In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room |
160; 173 | 0.77 |
| SECONDARY Physician Confidence Measured by a Survey |
4.6; 4.5 | 0.73 |
| SECONDARY Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR |
4; 3 | 1.0 |
| SECONDARY Post-operative Urethral Discomfort Measured by Pain Scales |
2.3; 2.1 | 0.78 |
| SECONDARY Trial of Void Results |
19; 9 | 0.04 sig |
Eligibility Criteria
Inclusion Criteria
- Females only
- Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
- Age > or = 18 years, no upper age limit
- Able and willing to consent
Exclusion Criteria
- Planned surgical procedure where cystoscopy will not be used
- Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
- age <18 years
- pregnancy
- unable/unwilling to participate
- history of allergy or adverse reaction to phenazopyridine
- hepatic dysfunction
- known phenazopyridine hypersensitivity
- history of urologic surgery
- presence of ureteral stents prior to the planned surgical procedure
- concomitant suprapubic catheter placement
Data sourced from ClinicalTrials.gov (NCT02424149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.