Phenazopyridine for Confirmation of Ureteral Patency

Cystoscopy Clinical Trial

— Phenazo  

Official title:

Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424149
• Other study ID #: HHC-2015-0008
• Status: Completed
• Phase: N/A
• First received: April 8, 2015
• Last updated: January 25, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Hartford Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cystoscopy

Intervention

Drug:
• Phenazopyridine

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to visualize ureteral urine flow intraoperatively measured by timing in the operating room		Day of surgery	No
Secondary	Physician confidence measured by a survey		day of surgery (day 0)	No
Secondary	Additional interventions: measured by use of IV fluids, IV lasix, IV methylene blue, or ureteral stent placement in OR	this is a composite measure and will be reported as a single value for each arm	day of surgery (day 0)	No
Secondary	Post-operative urethral discomfort measured by pain scales		duration of hospital stay, an expected average of 1 day	No
Secondary	Cost measured by case duration and standard operating room cost		Day of surgery (day 0)	No