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Evaluation of Fluorescein Use During Cystoscopy

Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02703558
Acronym
EFLUC
Enrollment
0
Registered
2016-03-09
Start date
2016-03-31
Completion date
2018-01-10
Last updated
2018-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraoperative Cystoscopy

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.

Interventions

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Time required to complete cystoscopy30 minThe attending surgeon of each case will document the time required to complete the cystoscopic assessment.
Time required to visualize ureteral jets30 minThe attending surgeon of each case will document the time required to visualize the right and left ureters.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026