NCT02476448

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 19, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

October 23, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

February 24, 2015

Results QC Date

August 22, 2018

Last Update Submit

October 22, 2019

Conditions

Injury of Ureter

Keywords

ureteral jetpelvic surgerycystoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    5 minutes

Secondary Outcomes (1)

  • Surgeon Satisfaction

    5 mins

Other Outcomes (1)

  • Number of Participants With Urinary Tract Infections

    6 weeks

Study Arms (4)

Normal Saline

ACTIVE COMPARATOR

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

Drug: Normal saline

Dextrose 10%

EXPERIMENTAL

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

Drug: Dextrose 10%

Phenazopyridine

EXPERIMENTAL

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

Drug: Phenazopyridine

Sodium Fluorescein

EXPERIMENTAL

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

Drug: Sodium Fluorescein

Interventions

Normal salineDRUG

Used to distend the bladder for cystoscopic evaluation

Also known as: Saline, NS
Normal Saline
PhenazopyridineDRUG

Administered orally preoperatively and assessed during cystoscopy

Also known as: Pyridium, AZO
Phenazopyridine
Dextrose 10%DRUG

Used to distend the bladder for cystoscopic evaluation

Also known as: D10
Dextrose 10%
Sodium FluoresceinDRUG

Administered intravenously and assessed during cystoscopy

Also known as: Fluorescein, Fluorocyte
Sodium Fluorescein

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Related Publications (1)

  • Espaillat-Rijo L, Siff L, Alas AN, Chadi SA, Zimberg S, Vaish S, Davila GW, Barber M, Hurtado EA. Intraoperative Cystoscopic Evaluation of Ureteral Patency: A Randomized Controlled Trial. Obstet Gynecol. 2016 Dec;128(6):1378-1383. doi: 10.1097/AOG.0000000000001750.

    PMID: 27824741DERIVED

MeSH Terms

Interventions

Saline SolutionSodium ChloridePhenazopyridineFluorescein

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsAminopyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluoresceinsSpiro CompoundsHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsXanthenesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingPolycyclic Compounds

Limitations and Caveats

Weaknesses include that without any postoperative diagnoses of ureteral injury, we cannot comment on the sensitivity or specificity of each method.

Results Point of Contact

Title
Dr. Eric Hurtado
Organization
Cleveland Clinic Florida
hurtade@ccf.org
954-659-5559

Study Officials

  • Guillermo Davila, MD

    Cleveland Clinic Florida

    STUDY CHAIR

  • Alexandriah Alas, MD

    Cleveland Clinic Florida

    STUDY DIRECTOR

  • Luis M Espaillat, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

  • Eric A Hurtado, MD

    Cleveland Clinic Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Quality Assurance

Study Record Dates

First Submitted

February 24, 2015

First Posted

June 19, 2015

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

July 1, 2016

Last Updated

October 23, 2019

Results First Posted

October 23, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)