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Phenazopyridine for Confirmation of Ureteral Patency (Phenazo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02424149
Recruitment Status : Completed
First Posted : April 22, 2015
Results First Posted : December 5, 2016
Last Update Posted : December 5, 2016
Sponsor:
Information provided by (Responsible Party):
Katie Propst, Hartford Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cystoscopy Drug: Phenazopyridine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy
Study Start Date : April 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
No preoperative phenazopyridine
Experimental: Phenazopyridine
Preoperative phenazopyridine
 Drug: Phenazopyridine
Other Name: Pyridium


Outcome Measures
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Primary Outcome Measures :
  1. Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room [ Time Frame: Day of surgery ]
    Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.


Secondary Outcome Measures :
  1. Physician Confidence Measured by a Survey [ Time Frame: day of surgery (day 0) ]
    Surgeon response to the question: "I am confident that ureteral injury was ruled out in this patient" on a 5-point Likert scale where 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, 5 = strongly agree

  2. Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR [ Time Frame: day of surgery (day 0) ]
    this is a composite measure and will be reported as a single value for each arm as number of additional interventions

  3. Post-operative Urethral Discomfort Measured by Pain Scales [ Time Frame: post operative day 1 ]
    Measured prior to catheter removal using a 10 point visual analog pain scale: Zero represented no pain, Ten represented the most severe pain.

  4. Trial of Void Results [ Time Frame: Day of hospital discharge ]
    Number of subjects that failed a back-filled trial of void on the day of hospital discharge, up to 2 days after surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424149


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Katie Propst, Fellow, Hartford Hospital
ClinicalTrials.gov Identifier: NCT02424149    
Other Study ID Numbers: HHC-2015-0008
First Posted: April 22, 2015    Key Record Dates
Results First Posted: December 5, 2016
Last Update Posted: December 5, 2016
Last Verified: October 2016