JET: Evaluation of Ureteral Jets on Cystoscopy

Sponsor
Cecilia Calvo (Other)
Overall Status
Completed
CT.gov ID
NCT02476448
Collaborator
The Cleveland Clinic (Other)
176
1
4
17
10.4

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Evaluation of Ureteral Jets on Cystoscopy: A Randomized Controlled Trial
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Normal Saline

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

Drug: Normal saline
Used to distend the bladder for cystoscopic evaluation
Other Names:
  • Saline
  • NS
  • Experimental: Dextrose 10%

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

    Drug: Dextrose 10%
    Used to distend the bladder for cystoscopic evaluation
    Other Names:
  • D10
  • Experimental: Phenazopyridine

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

    Drug: Phenazopyridine
    Administered orally preoperatively and assessed during cystoscopy
    Other Names:
  • Pyridium
  • AZO
  • Experimental: Sodium Fluorescein

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

    Drug: Sodium Fluorescein
    Administered intravenously and assessed during cystoscopy
    Other Names:
  • Fluorescein
  • Fluorocyte
  • Outcome Measures

    Primary Outcome Measures

    1. Ureteral Jet Visibility [5 minutes]

      Surgeons will chose from a likert scales as either: not visible Somewhat visible clearly visible This will be completed during the cystoscopic evaluation

    Secondary Outcome Measures

    1. Surgeon Satisfaction [5 mins]

      A 4 point likert scale will be completed during the procedure to assess satisfaction as follows: very satisfied satisfied somewhat satisfied unacceptable

    Other Outcome Measures

    1. Number of Participants With Urinary Tract Infections [6 weeks]

      Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Florida Weston Florida United States 33331

    Sponsors and Collaborators

    • Cecilia Calvo
    • The Cleveland Clinic

    Investigators

    • Study Chair: Guillermo Davila, MD, Cleveland Clinic Florida
    • Study Director: Alexandriah Alas, MD, Cleveland Clinic Florida
    • Principal Investigator: Luis M Espaillat, MD, Cleveland Clinic Florida
    • Principal Investigator: Eric A Hurtado, MD, Cleveland Clinic Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cecilia Calvo, Quality Assurance, Cleveland Clinic Florida
    ClinicalTrials.gov Identifier:
    NCT02476448
    Other Study ID Numbers:
    • FLA 15-015
    First Posted:
    Jun 19, 2015
    Last Update Posted:
    Oct 23, 2019
    Last Verified:
    Oct 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Cecilia Calvo, Quality Assurance, Cleveland Clinic Florida

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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
    Period Title: Overall Study
    STARTED 44 44 44 44
    COMPLETED 44 44 44 44
    NOT COMPLETED 0 0 0 0

    Baseline Characteristics

    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein Total
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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 Total of all reporting groups
    Overall Participants 44 44 44 44 176
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    63.2
    (13.8)
    59.3
    (12.1)
    60
    (9.7)
    60.3
    (13.9)
    60.7
    (12.4)
    Sex: Female, Male (Count of Participants)
    Female
    44
    100%
    44
    100%
    44
    100%
    44
    100%
    176
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    BMI (kg/m^2) [Mean (Full Range) ]
    Mean (Full Range) [kg/m^2]
    26.4
    26.9
    30.3
    26.7
    27.6

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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
    Measure Participants 44 44 44 44
    Clearly Visible
    22
    50%
    35
    79.5%
    27
    61.4%
    41
    93.2%
    Somewhat Visible
    17
    38.6%
    9
    20.5%
    16
    36.4%
    3
    6.8%
    Not Visible
    5
    11.4%
    0
    0%
    1
    2.3%
    0
    0%
    2. Secondary Outcome
    Title Surgeon Satisfaction
    Description A 4 point likert scale will be completed during the procedure to assess satisfaction as follows: very satisfied satisfied somewhat satisfied unacceptable
    Time Frame 5 mins

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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
    Measure Participants 44 44 44 44
    Very Satisfied
    12
    27.3%
    27
    61.4%
    12
    27.3%
    26
    59.1%
    Satisfied
    14
    31.8%
    12
    27.3%
    15
    34.1%
    13
    29.5%
    Somewhat Satisfied
    13
    29.5%
    5
    11.4%
    12
    27.3%
    4
    9.1%
    Unacceptable
    5
    11.4%
    0
    0%
    5
    11.4%
    1
    2.3%
    3. Other Pre-specified Outcome
    Title Number of Participants With Urinary Tract Infections
    Description Medical records will be followed prospectively for 6 weeks to assess for incidence of urinary tract infections within different groups.
    Time Frame 6 weeks

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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
    Measure Participants 44 44 44 44
    Count of Participants [Participants]
    10
    22.7%
    13
    29.5%
    9
    20.5%
    10
    22.7%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Arm/Group Description Infused into the bladder to allow for visualization of bladder walls and urine jets. Normal saline: Used to distend the bladder for cystoscopic evaluation 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 Will be administered (PO) preoperatively and will be evaluated for its colorization properties during cystoscopy. Phenazopyridine: Administered orally preoperatively and assessed during cystoscopy 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
    All Cause Mortality
    Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/44 (0%)
    Serious Adverse Events
    Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/44 (4.5%) 1/44 (2.3%) 0/44 (0%) 1/44 (2.3%)
    Cardiac disorders
    Elevated blood pressure 1/44 (2.3%) 0/44 (0%) 0/44 (0%) 0/44 (0%)
    chest pain 0/44 (0%) 1/44 (2.3%) 0/44 (0%) 0/44 (0%)
    Nervous system disorders
    parathesia 1/44 (2.3%) 0/44 (0%) 0/44 (0%) 0/44 (0%)
    Renal and urinary disorders
    Post-op retention 0/44 (0%) 0/44 (0%) 0/44 (0%) 1/44 (2.3%)
    Other (Not Including Serious) Adverse Events
    Normal Saline Dextrose 10% Phenazopyridine Sodium Fluorescein
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/44 (0%) 0/44 (0%) 0/44 (0%) 0/44 (0%)

    Limitations/Caveats

    Weaknesses include that without any postoperative diagnoses of ureteral injury, we cannot comment on the sensitivity or specificity of each method.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Eric Hurtado
    Organization Cleveland Clinic Florida
    Phone 954-659-5559
    Email hurtade@ccf.org
    Responsible Party:
    Cecilia Calvo, Quality Assurance, Cleveland Clinic Florida
    ClinicalTrials.gov Identifier:
    NCT02476448
    Other Study ID Numbers:
    • FLA 15-015
    First Posted:
    Jun 19, 2015
    Last Update Posted:
    Oct 23, 2019
    Last Verified:
    Oct 1, 2019