Evaluation of Ureteral Jets on Cystoscopy

Not Applicable

Completed

• Conditions: Injury of Ureter
• Interventions: Drug: Normal saline; Drug: Sodium Fluorescein; Drug: Dextrose 10%; Drug: Phenazopyridine

• Registration Number: NCT02476448
• Lead Sponsor: Cecilia Calvo

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-24
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-19
• Primary Completion: 2016-02
• Study Completion: 2016-07
• Results First Submitted: 2018-08-22
• Status Verified: 2019-10
• Results First Submitted QC: 2019-10-22
• Last Update Submitted: 2019-10-22
• Results First Posted: 2019-10-23
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal saline	Infused into the bladder to allow for visualization of bladder walls and urine jets.
Sodium Fluorescein	Sodium Fluorescein	Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy.
Dextrose 10%	Dextrose 10%	Infused into the bladder to allow for visualization of bladder walls and colored urine jets.
Phenazopyridine	Phenazopyridine	Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy.

Primary Outcome Measures

Name	Time	Method
Ureteral Jet Visibility	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

Secondary Outcome Measures

Name	Time	Method
Surgeon Satisfaction	5 mins	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

Trial Locations

Locations (1)

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States