Evaluation of Ureteral Jets on Cystoscopy (JET)

October 22, 2019 updated by: Cecilia Calvo

Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Weston, Florida, United States, 33331
        • Cleveland Clinic Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Normal Saline
Infused into the bladder to allow for visualization of bladder walls and urine jets.
Drug: Normal saline
Used to distend the bladder for cystoscopic evaluation
Other Names:
  • Saline
  • NS
EXPERIMENTAL: Dextrose 10%
Infused into the bladder to allow for visualization of bladder walls and colored urine jets.
Drug: Dextrose 10%
Used to distend the bladder for cystoscopic evaluation
Other Names:
  • D10
EXPERIMENTAL: Phenazopyridine
Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy.
Drug: Phenazopyridine
Administered orally preoperatively and assessed during cystoscopy
Other Names:
  • Pyridium
  • AZO
EXPERIMENTAL: Sodium Fluorescein
Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.
Drug: Sodium Fluorescein
Administered intravenously and assessed during cystoscopy
Other Names:
  • Fluorescein
  • Fluorocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ureteral Jet Visibility
Time Frame: 5 minutes

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
5 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgeon Satisfaction
Time Frame: 5 mins

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
5 mins

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Urinary Tract Infections
Time Frame: 6 weeks
Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cecilia Calvo

Collaborators

The Cleveland Clinic

Investigators

  • Study Chair: Guillermo Davila, MD, Cleveland Clinic Florida
  • Principal Investigator: Luis M Espaillat, MD, Cleveland Clinic Florida
  • Principal Investigator: Eric A Hurtado, MD, Cleveland Clinic Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

February 24, 2015

First Submitted That Met QC Criteria

June 18, 2015

First Posted (ESTIMATE)

June 19, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2019

Last Update Submitted That Met QC Criteria

October 22, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FLA 15-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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