Evaluation of Fluorescein Use During Cystoscopy

NCT02703558 | Withdrawn

• 1 other identifier: IRB00085778
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intraoperative Cystoscopy

Outcome Measures

Primary Outcomes (2)

• Time required to complete cystoscopy

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

  30 min

• Time required to visualize ureteral jets

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

  30 min

Study Arms (3)

No dye

NO INTERVENTION

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

Phenazopyridine

ACTIVE COMPARATOR

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

Fluorescein

ACTIVE COMPARATOR

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

Interventions

Phenazopyridine DRUG

Also known as: Pyridium

Phenazopyridine

Fluorescein DRUG

Fluorescein

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Interventions

Phenazopyridine; Fluorescein

Intervention Hierarchy (Ancestors)

Aminopyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 9, 2016
• Study Start: March 1, 2016
• Primary Completion: January 10, 2018
• Study Completion: January 10, 2018
• Last Updated: January 12, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share