Evaluation of Ureteral Jets on Cystoscopy

NCT ID: NCT02476448

Last Updated: 2019-10-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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

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Injury of Ureter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Normal Saline

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

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

Used to distend the bladder for cystoscopic evaluation

Dextrose 10%

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

Group Type EXPERIMENTAL

Dextrose 10%

Intervention Type DRUG

Used to distend the bladder for cystoscopic evaluation

Phenazopyridine

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

Group Type EXPERIMENTAL

Phenazopyridine

Intervention Type DRUG

Administered orally preoperatively and assessed during cystoscopy

Sodium Fluorescein

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

Group Type EXPERIMENTAL

Sodium Fluorescein

Intervention Type DRUG

Administered intravenously and assessed during cystoscopy

Interventions

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Normal saline

Used to distend the bladder for cystoscopic evaluation

Intervention Type DRUG

Phenazopyridine

Administered orally preoperatively and assessed during cystoscopy

Intervention Type DRUG

Dextrose 10%

Used to distend the bladder for cystoscopic evaluation

Intervention Type DRUG

Sodium Fluorescein

Administered intravenously and assessed during cystoscopy

Intervention Type DRUG

Other Intervention Names

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Saline NS Pyridium AZO D10 Fluorescein Fluorocyte

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role collaborator

Cecilia Calvo

OTHER

Sponsor Role lead

Responsible Party

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Cecilia Calvo

Quality Assurance

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Guillermo Davila, MD

Role: STUDY_CHAIR

Cleveland Clinic Florida

Alexandriah Alas, MD

Role: STUDY_DIRECTOR

Cleveland Clinic Florida

Luis M Espaillat, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Eric A Hurtado, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Florida

Locations

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Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27824741 (View on PubMed)

Other Identifiers

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FLA 15-015

Identifier Type: -

Identifier Source: org_study_id

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