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Phenazopyridine for Confirmation of Ureteral Patency

Information source: Hartford Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystoscopy

Intervention: Phenazopyridine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Hartford Hospital

Overall contact:
Katie Propst, MD, Phone: 860-972-1908, Email: katie.propst@hhchealth.gov


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.

Clinical Details

Official title: Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: Time to visualize ureteral urine flow intraoperatively measured by timing in the operating room

Secondary outcome:

Physician confidence measured by a survey

Additional interventions: measured by use of IV fluids, IV lasix, IV methylene blue, or ureteral stent placement in OR

Post-operative urethral discomfort measured by pain scales

Cost measured by case duration and standard operating room cost


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Females only

- Planned surgical procedure where cystoscopy will be used to document ureteral urine


- 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

Locations and Contacts

Katie Propst, MD, Phone: 860-972-1908, Email: katie.propst@hhchealth.gov

Hartford Hospital, Hartford, Connecticut 06106, United States; Recruiting
Katie Propst, MD, Phone: 860-972-1908
Additional Information

Starting date: April 2015
Last updated: April 17, 2015

Page last updated: August 23, 2015

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