Evaluation of Ureteral Jets on Cystoscopy

Cecilia Calvo176 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

176

Conditions

Injury of Ureter

Interventions

Normal salineDRUG

Used to distend the bladder for cystoscopic evaluation

PhenazopyridineDRUG

Administered orally preoperatively and assessed during cystoscopy

Dextrose 10%DRUG

Used to distend the bladder for cystoscopic evaluation

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cleveland Clinic Florida

Weston, Florida, United States

Outcomes

Primary Outcomes

Ureteral Jet Visibility

Surgeons will chose from a likert scales as either: 1. not visible 2. Somewhat visible 3. clearly visible This will be completed during the cystoscopic evaluation

Time frame: 5 minutes

Secondary Outcomes

Surgeon Satisfaction

A 4 point likert scale will be completed during the procedure to assess satisfaction as follows: 1. very satisfied 2. satisfied 3. somewhat satisfied 4. unacceptable

Time frame: 5 mins

Data from ClinicalTrials.gov

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