Study Results
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View full resultsBasic Information
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COMPLETED
NA
176 participants
INTERVENTIONAL
2015-02-28
2016-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Normal Saline
Infused into the bladder to allow for visualization of bladder walls and urine jets.
Normal saline
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.
Dextrose 10%
Used to distend the bladder for cystoscopic evaluation
Phenazopyridine
Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy.
Phenazopyridine
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.
Sodium Fluorescein
Administered intravenously and assessed during cystoscopy
Interventions
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Normal saline
Used to distend the bladder for cystoscopic evaluation
Phenazopyridine
Administered orally preoperatively and assessed during cystoscopy
Dextrose 10%
Used to distend the bladder for cystoscopic evaluation
Sodium Fluorescein
Administered intravenously and assessed during cystoscopy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing a cystoscopy or as part of their planned procedure
Exclusion Criteria
* known prior surgical removal of kidney or ureteral obstruction
* Current ureteral stent placed
* Allergy to any of the interventions
18 Years
FEMALE
Yes
Sponsors
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The Cleveland Clinic
OTHER
Cecilia Calvo
OTHER
Responsible Party
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Cecilia Calvo
Quality Assurance
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
Countries
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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.
Other Identifiers
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FLA 15-015
Identifier Type: -
Identifier Source: org_study_id
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