EFLUC: Evaluation of Fluorescein Use During Cystoscopy

Sponsor
Johns Hopkins University (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02703558
Collaborator
(none)
0
3
22.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial
Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Jan 10, 2018
Actual Study Completion Date :
Jan 10, 2018

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Time required to complete cystoscopy [30 min]

      The attending surgeon of each case will document the time required to complete the cystoscopic assessment.

    2. Time required to visualize ureteral jets [30 min]

      The attending surgeon of each case will document the time required to visualize the right and left ureters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT02703558
    Other Study ID Numbers:
    • IRB00085778
    First Posted:
    Mar 9, 2016
    Last Update Posted:
    Jan 12, 2018
    Last Verified:
    Jan 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No

    Study Results

    No Results Posted as of Jan 12, 2018