Injury of UreterJETNCT02476448

Evaluation of Ureteral Jets on Cystoscopy

A study testing Normal saline, Phenazopyridine and Dextrose 10% in people with Injury of Ureter, run by Cecilia Calvo at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Injury of Ureter
What is being tested?: Normal saline, Phenazopyridine and Dextrose 10%
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Jul 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

adult
undergoing a cystoscopy or as part of their planned procedure

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Cleveland Clinic Florida
Weston, Florida, 33331

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Injury of Ureter
Being tested: Normal saline, Phenazopyridine, Dextrose 10%, Sodium Fluorescein
Keywords: ureteral jet, pelvic surgery, cystoscopy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Normal salineDrug
Also called Saline, NS
Used to distend the bladder for cystoscopic evaluation
PhenazopyridineDrug
Also called Pyridium, AZO
Administered orally preoperatively and assessed during cystoscopy
Dextrose 10%Drug
Also called D10
Used to distend the bladder for cystoscopic evaluation
Sodium FluoresceinDrug
Also called Fluorescein, Fluorocyte
Administered intravenously and assessed during cystoscopy

Study groups in NCT02476448
Study group	Role	What they receive
Normal Saline	Active comparator	Infused into the bladder to allow for visualization of bladder walls and urine jets. Receives: Drug: Normal saline
Dextrose 10%	Experimental	Infused into the bladder to allow for visualization of bladder walls and colored urine jets. Receives: Drug: Dextrose 10%
Phenazopyridine	Experimental	Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy. Receives: Drug: Phenazopyridine
Sodium Fluorescein	Experimental	Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Receives: Drug: Sodium Fluorescein

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 5 minutes

Secondary outcomes (1)

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
Measured: 5 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Jul 2016

First posted19 Jun 2015 (estimated)
Study startFeb 2015
Primary completionFeb 2016
Study completionJul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Injury of UreterStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02476448
Sponsor's protocol ID: FLA 15-015
Acronym: JET
Status last verified: Oct 2019
First submitted: 24 Feb 2015
Last updated: 23 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 27824741

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Not yet recruitingPhase 3
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients
Ureter Injury
Not yet recruitingPhase 4
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
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Active, not recruitingPhase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
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All Injury of Ureter trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02476448
Acronym / sponsor ID: JET / FLA 15-015
Conditions: Injury of Ureter
Keywords: ureteral jet, pelvic surgery, cystoscopy
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Cecilia CalvoUniversity, hospital or other
Collaborators: The Cleveland Clinic
Study start: Feb 2015
Primary completion: Feb 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 19 Jun 2015 (estimated)
Results: Posted 23 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Normal Saline	Active comparator	Drug: Normal salineInfused into the bladder to allow for visualization of bladder walls and urine jets.
Dextrose 10%	Experimental	Drug: Dextrose 10%Infused into the bladder to allow for visualization of bladder walls and colored urine jets.
Phenazopyridine	Experimental	Drug: PhenazopyridineWill be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy.
Sodium Fluorescein	Experimental	Drug: Sodium FluoresceinWill be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

adult
undergoing a cystoscopy or as part of their planned procedure

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Normal salineAlso: Saline, NSUsed to distend the bladder for cystoscopic evaluation	Drug	Normal Saline
PhenazopyridineAlso: Pyridium, AZOAdministered orally preoperatively and assessed during cystoscopy	Drug	Phenazopyridine
Dextrose 10%Also: D10Used to distend the bladder for cystoscopic evaluation	Drug	Dextrose 10%
Sodium FluoresceinAlso: Fluorescein, FluorocyteAdministered intravenously and assessed during cystoscopy	Drug	Sodium Fluorescein

Primary outcome

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

1 secondary outcome

Surgeon Satisfaction
Time frame: 5 mins

Results and safety

Results posted to the registry on 23 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Saline	44	44
Dextrose 10%	44	44
Phenazopyridine	44	44
Sodium Fluorescein	44	44

Primary outcome: Ureteral Jet Visibility

Time frame: 5 minutes. Count of participants. Unit: Participants

Measure	Normal Saline n = 44	Dextrose 10% n = 44	Phenazopyridine n = 44	Sodium Fluorescein n = 44
Clearly Visible	22	35	27	41
Somewhat Visible	17	9	16	3
Not Visible	5	0	1	0

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Saline	2 of 44 (4.5%)	0 of 44 (0%)	0 of 44
Dextrose 10%	1 of 44 (2.3%)	0 of 44 (0%)	0 of 44
Phenazopyridine	0 of 44 (0%)	0 of 44 (0%)	0 of 44
Sodium Fluorescein	1 of 44 (2.3%)	0 of 44 (0%)	0 of 44

Limitations and caveats (from the sponsor): Weaknesses include that without any postoperative diagnoses of ureteral injury, we cannot comment on the sensitivity or specificity of each method.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27824741Espaillat-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.
Individual participant dataSharing planned: No

Related trials for Injury of Ureter

RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Not yet recruitingPhase 3
Indigotindisulfonate Sodium Injection, USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients
Ureter Injury
Not yet recruitingPhase 4
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
Colorectal Cancer, Colorectal Surgery
Not yet recruiting
Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
Nephrolithiasis
Active, not recruitingPhase 1
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guillermo Davila, MD study chair

Cleveland Clinic Florida

Alexandriah Alas, MD study director

Cleveland Clinic Florida

Luis M Espaillat, MD principal investigator

Cleveland Clinic Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Normal saline, Phenazopyridine and Dextrose 10% in people with Injury of Ureter, run by Cecilia Calvo at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ureteral Jet Visibility (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02476448, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.