Evaluation of Ureteral Jets on Cystoscopy

Study Overview
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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.

Official Title
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Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial

Conditions
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Injury of Ureter

Intervention / Treatment
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* Drug: Normal saline
* Drug: Phenazopyridine
* Drug: Dextrose 10%
* Drug: Sodium Fluorescein


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal Saline<br>Infused into the bladder to allow for visualization of bladder walls and urine jets. | Drug: Normal saline<br>* Used to distend the bladder for cystoscopic evaluation<br>* Other names: NS;|
| Experimental: Dextrose 10%<br>Infused into the bladder to allow for visualization of bladder walls and colored urine jets. | Drug: Dextrose 10%<br>* Used to distend the bladder for cystoscopic evaluation<br>* Other names: D10;|
| Experimental: Phenazopyridine<br>Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy. | Drug: Phenazopyridine<br>* Administered orally preoperatively and assessed during cystoscopy<br>* Other names: AZO;|
| Experimental: Sodium Fluorescein<br>Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. | Drug: Sodium Fluorescein<br>* Administered intravenously and assessed during cystoscopy<br>* Other names: Fluorocyte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ureteral Jet Visibility | Surgeons will chose from a likert scales as either: not visible Somewhat visible clearly visible This will be completed during the cystoscopic evaluation | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Satisfaction | A 4 point likert scale will be completed during the procedure to assess satisfaction as follows: very satisfied satisfied somewhat satisfied unacceptable | 5 mins | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteral jet, pelvic surgery, cystoscopy