Evaluation of Fluorescein Use During Cystoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-01-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Intraoperative Cystoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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No dye

Participants will not receive a preoperative or intraoperative dye prior to their intraoperative concomitant cystoscopy.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Phenazopyridine

Intervention Type DRUG

Fluorescein

Participants will receive 0.25cc of 10% intravenous sodium fluorescein administered by anesthesia during their surgery, immediately prior to their intraoperative concomitant cystoscopy.

Group Type ACTIVE_COMPARATOR

Fluorescein

Intervention Type DRUG

Interventions

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Phenazopyridine

Intervention Type DRUG

Fluorescein

Intervention Type DRUG

Other Intervention Names

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Pyridium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No