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Intravenous Sodium Fluorescein Versus Oral Phenazopyridine for Ureteral Patency

Sponsor
University Hospitals Cleveland Medical Center (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02757417
Collaborator
Megan Billow (Other), Graham Chapman (Other), Sangeeta Mahajan (Other), Alex Soriano (Other), Sherif El-Nashar (Other)
0
Enrollment
1
Location
2
Arms
41
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Randomized Trial Comparing Intaoperative Intravenous Sodium Fluorescein to Pre-Operative Oral Phenazopyridine For Evaluation of Ureteral Patency
Actual Study Start Date :
Jul 1, 2016
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Drug: phenazopyridine

Outcome Measures

Primary Outcome Measures

  1. differences in time that elapses between starting cystoscopy and identifying both ureteral jets between treatment groups [12 months]

Secondary Outcome Measures

  1. number of participants with intra-operative and immediate and post-operative treatment-related adverse events as assessed by CTCAE v4.0 [12 months]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106

Sponsors and Collaborators

  • University Hospitals Cleveland Medical Center
  • Megan Billow
  • Graham Chapman
  • Sangeeta Mahajan
  • Alex Soriano
  • Sherif El-Nashar

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:
NCT02757417
Other Study ID Numbers:
  • UHcaseMC1
First Posted:
May 2, 2016
Last Update Posted:
May 6, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided

Study Results

No Results Posted as of May 6, 2022