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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
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This study evaluates 4 different methods to aid surgeons to visualize ureteral jets on cystoscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Active Comparator | Infused into the bladder to allow for visualization of bladder walls and urine jets. |
|
| Dextrose 10% | Experimental | Infused into the bladder to allow for visualization of bladder walls and colored urine jets. |
|
| Phenazopyridine | Experimental | Will be administered (orally) preoperatively and will be evaluated for its colorization properties during cystoscopy. |
|
| Sodium Fluorescein | Experimental | Will be administered (intravenously) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Drug | Used to distend the bladder for cystoscopic evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ureteral Jet Visibility | Surgeons will chose from a likert scales as either:
| 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Surgeon Satisfaction | A 4 point likert scale will be completed during the procedure to assess satisfaction as follows:
| 5 mins |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Urinary Tract Infections | Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups. | 6 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guillermo Davila, MD | Cleveland Clinic Florida | Study Chair |
| Alexandriah Alas, MD | Cleveland Clinic Florida | Study Director |
| Luis M Espaillat, MD | Cleveland Clinic Florida | Principal Investigator |
| Eric A Hurtado, MD | Cleveland Clinic Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27824741 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Phenazopyridine | Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy |
| FG003 | Sodium Fluorescein | Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Dextrose 10% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ureteral Jet Visibility | Surgeons will chose from a likert scales as either:
| Posted | Count of Participants | Participants | 5 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated blood pressure | Cardiac disorders | Non-systematic Assessment |
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Weaknesses include that without any postoperative diagnoses of ureteral injury, we cannot comment on the sensitivity or specificity of each method.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Hurtado | Cleveland Clinic Florida | 954-659-5559 | hurtade@ccf.org |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| D010621 | Phenazopyridine |
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Phenazopyridine | Drug | Administered orally preoperatively and assessed during cystoscopy |
|
|
| Dextrose 10% | Drug | Used to distend the bladder for cystoscopic evaluation |
|
|
| Sodium Fluorescein | Drug | Administered intravenously and assessed during cystoscopy |
|
|
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
| BG002 | Phenazopyridine | Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy |
| BG003 | Sodium Fluorescein | Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| OG002 |
| Phenazopyridine |
Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy |
| OG003 | Sodium Fluorescein | Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy |
|
|
| Secondary | Surgeon Satisfaction | A 4 point likert scale will be completed during the procedure to assess satisfaction as follows:
| Posted | Count of Participants | Participants | 5 mins |
|
|
|
| Other Pre-specified | Number of Participants With Urinary Tract Infections | Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups. | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 44 |
| 2 |
| 44 |
| 0 |
| 44 |
| EG001 | 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 | 0 | 44 | 1 | 44 | 0 | 44 |
| EG002 | Phenazopyridine | Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy | 0 | 44 | 0 | 44 | 0 | 44 |
| EG003 | Sodium Fluorescein | Will be administered (IV) prior to the cystoscopy and will be evaluated for its colorization properties during cystoscopy. Sodium Fluorescein: Administered intravenously and assessed during cystoscopy | 0 | 44 | 1 | 44 | 0 | 44 |
| parathesia | Nervous system disorders | Non-systematic Assessment |
|
| chest pain | Cardiac disorders | Non-systematic Assessment |
|
| Post-op retention | Renal and urinary disorders | Non-systematic Assessment | W/ bladder rupture POD#4 |
|
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| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011083 | Polycyclic Compounds |
| Male |
|
| Satisfied |
|
| Somewhat Satisfied |
|
| Unacceptable |
|