Evaluation of Ureteral Jets on Cystoscopy (JET)

Cecilia Calvo

Status: Completed

Conditions: Injury of Ureter

Treatments: Drug: Phenazopyridine; Drug: Dextrose 10%; Drug: Sodium Fluorescein; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02476448

FLA 15-015

Details and patient eligibility

About

This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.

Full description

This study proposes to test and compare the surgeon's impression/confidence in identifying ureteral jets using 3 other methods in contrast to standard diagnostic cystoscopy: 1) cystoscopy with Dextrose 10% solution, 2) cystoscopy with phenazopyridine and 3) IV sodium fluorescein 4) standard cystoscopy with saline.

Enrollment: 176 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult
• undergoing a cystoscopy or as part of their planned procedure

Exclusion criteria

• Chronic kidney disease
• known prior surgical removal of kidney or ureteral obstruction
• Current ureteral stent placed
• Allergy to any of the interventions

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 4 patient groups

Normal Saline

Active Comparator group

Description:

Infused into the bladder to allow for visualization of bladder walls and urine jets.

Treatment:

Drug: Normal saline

Dextrose 10%

Experimental group

Description:

Infused into the bladder to allow for visualization of bladder walls and colored urine jets.

Treatment:

Drug: Dextrose 10%

Phenazopyridine

Experimental group

Description:

Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy.

Treatment:

Drug: Phenazopyridine

Sodium Fluorescein

Experimental group

Description:

Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.

Treatment:

Drug: Sodium Fluorescein