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OpenTrials
Completed

NCT Number: NCT02476448

Evaluation of Ureteral Jets on Cystoscopy

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

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Key information

Conditions

Injury of Ureter

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

Used to distend the bladder for cystoscopic evaluation

Other names: Saline, NS

Phenazopyridine

Drug

Administered orally preoperatively and assessed during cystoscopy

Other names: Pyridium, AZO

Dextrose 10%

Drug

Used to distend the bladder for cystoscopic evaluation

Other names: D10

Sodium Fluorescein

Drug

Administered intravenously and assessed during cystoscopy

Other names: Fluorescein, Fluorocyte

Primary outcomes

  1. Ureteral Jet Visibility

    Time frame: 5 minutes

    Surgeons will chose from a likert scales as either:

    • not visible
    • Somewhat visible
    • clearly visible This will be completed during the cystoscopic evaluation

Secondary outcomes

  1. Surgeon Satisfaction

    Time frame: 5 mins

    A 4 point likert scale will be completed during the procedure to assess satisfaction as follows:

    • very satisfied
    • satisfied
    • somewhat satisfied
    • unacceptable

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cecilia Calvo

Other

Collaborators

  • The Cleveland Clinic

Registry information

Official study title

Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial

Acronym: JET

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 19, 2015
Registry last updated
Oct 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.