Phenazopyridine for Confirmation of Ureteral Patency

Hartford Hospital

Status: Completed

Conditions: Cystoscopy

Treatments: Drug: Phenazopyridine

Study type: Interventional

Funder types: Other

Identifiers

NCT02424149

HHC-2015-0008

Details and patient eligibility

About

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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 2 patient groups

Control

No Intervention group

Description:

No preoperative phenazopyridine

Phenazopyridine

Experimental group

Description:

Preoperative phenazopyridine

Treatment:

Drug: Phenazopyridine