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Completed

NCT Number: NCT02424149

Phenazopyridine for Confirmation of Ureteral Patency

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.

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Key information

Conditions

Cystoscopy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hartford Hospital

Hartford, Connecticut, 06106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenazopyridine

Drug

Other names: Pyridium

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hartford Hospital

Other

Registry information

Official study title

Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy

Acronym: Phenazo

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 22, 2015
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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