We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02757417
Recruitment Status : Withdrawn (Study never started)
First Posted : May 2, 2016
Last Update Posted : May 6, 2022
Sponsor:
Collaborators:
Megan Billow
Graham Chapman
Sangeeta Mahajan
Alex Soriano
Sherif El-Nashar
Information provided by (Responsible Party):
University Hospitals Cleveland Medical Center

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 2, 2016
Last Update Posted Date May 6, 2022
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)		 differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2016)		 number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency
Official Title  ICMJE A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
Brief Summary To determine the safety profile of sodium fluorescein in women undergoing cystoscopy during gynecologic surgery. To determine if either oral phenazopyridine or sodium fluorescein result in shorter cystoscopy times.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Ureteral Injury
Intervention  ICMJE
  • Drug: sodium fluorescein
  • Drug: phenazopyridine
Study Arms  ICMJE
  • Active Comparator: Sodium Fluorescein
    Patients will receive an intravenous dose of 0.25 mL of 10% (500 mg, 5 mL) sodium fluorescein at the time of cystoscope insertion, for a total dose of 25 mg. Cystoscopy will be performed in the standard fashion during the course of the operation.
    Intervention: Drug: sodium fluorescein
  • Active Comparator: oral phenazopyridine
    Patients randomized to the phenazopyridine arm will be given a 200 mg pill with a sip of water in the pre-operative area 1 hour before their scheduled procedure. Cystoscopy will be performed in the standard fashion during the course of the operation.
    Intervention: Drug: phenazopyridine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 2, 2022)		 0
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2016)		 88
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • - Patients must be 18 years or older as well as willing and able to provide informed consent
  • Patients undergoing a scheduled gynecologic procedure with cystoscopy

Exclusion Criteria:

  • - Patients are younger than 18 years
  • Patients are unable or unwilling to provide informed consent
  • Patients with a history of an allergic reaction to sodium fluorescein or phenazopyridine
  • Patients with a history of renal insufficiency
  • Patients with a history of liver disease
  • Patients with a history of sickle cell disease
  • Patients with a history of glucose-6-phosphate dehydrogenase deficiency
  • Patients with a history of chronic obstructive pulmonary disease or currently being treated for asthma
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02757417
Other Study ID Numbers  ICMJE UHcaseMC1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University Hospitals Cleveland Medical Center
Original Responsible Party David Sheyn, University Hospitals Cleveland Medical Center, Physician
Current Study Sponsor  ICMJE University Hospitals Cleveland Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Megan Billow
  • Graham Chapman
  • Sangeeta Mahajan
  • Alex Soriano
  • Sherif El-Nashar
Investigators  ICMJE Not Provided
PRS Account University Hospitals Cleveland Medical Center
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP