drugset / Trial / NCT02703558

Evaluation of Fluorescein Use During Cystoscopy

NCT02703558

RandomizedSingle-groupOpen-labelDiagnostic

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.

Timeline

Start
2016-03
Primary completion
2018-01-10
Completion
2018-01-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluorescein Diagnostic / imaging agent 0.25 ml Intravenous
Comparator Phenazopyridine Small molecule 200 mg Oral

Indications

No indication recorded.