Evaluation of Fluorescein Use During Cystoscopy (EFLUC)

January 10, 2018 updated by: Johns Hopkins University

Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial

This study is a prospective randomized controlled study. Female patients over 18 years of age, who present for treatment of pelvic organ prolapse and/or stress urinary incontinence at the Pelvic Floor Center at the Johns Hopkins Bayview Medical Center, and who consent to undergo a urogynecologic surgical procedure, will be considered for inclusion in the study. Their histories will be reviewed by their attending surgeon and if they meet inclusion and exclusion criteria, they will be recruited for participation. The primary investigator and co-investigators (attending physician, fellows) will determine patient eligibility. Regarding privacy issues, the patients will be consented for both the procedure and for the study with careful attention made to emphasize patient confidentiality. When the patient presents for surgery, they will be randomized to receive either preoperative pyridium or intraoperative fluorescein or no dye. Given the color differences between the dyes, blinding will not occur. The process for recruitment will be consistent and any deviations from the protocol will be reported to the Johns Hopkins Internal Review Board.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

• English speaking, female patients, ages 18 and older, undergoing urogynecologic surgery for pelvic organ prolapse or urinary incontinence with a planned concomitant cystoscopy at Johns Hopkins Bayview

Exclusion Criteria:

  • Non-English speaking,
  • Known allergic reactions or sensitivities to sodium fluorescein or phenazopyridine
  • Known glucose-6-phosphate dehydrogenase or nicotinamide adenine dinucleotide- methemoglobin reductase deficiency
  • Pregnant or breastfeeding
  • Known renal disease or renal failure
  • Undergoing concomitant non-urogynecologic procedures
  • Dementia or cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No dye
Participants will not receive a preoperative or intraoperative dye prior to their intraoperative concomitant cystoscopy.
Active Comparator: Phenazopyridine
Participants will receive a single 200mg oral dose of phenazopyridine with a sip of water 30 minutes prior to their surgery which involves an intraoperative concomitant cystoscopy.
Drug: Phenazopyridine
Other Names:
  • Pyridium
Active Comparator: Fluorescein
Participants will receive 0.25cc of 10% intravenous sodium fluorescein administered by anesthesia during their surgery, immediately prior to their intraoperative concomitant cystoscopy.
Drug: Fluorescein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required to complete cystoscopy
Time Frame: 30 min
The attending surgeon of each case will document the time required to complete the cystoscopic assessment.
30 min
Time required to visualize ureteral jets
Time Frame: 30 min
The attending surgeon of each case will document the time required to visualize the right and left ureters.
30 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 10, 2018

Study Completion (Actual)

January 10, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 3, 2016

First Posted (Estimate)

March 9, 2016

Study Record Updates

Last Update Posted (Actual)

January 12, 2018

Last Update Submitted That Met QC Criteria

January 10, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00085778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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