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临床试验/NCT02703558
NCT02703558撤回不适用

Evaluation of Fluorescein Use During Cystoscopy, a Randomized Control Trial

Johns Hopkins University0 个研究点开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Time required to complete cystoscopy

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Phenazopyridine (Drug)

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.

干预措施: Fluorescein (Drug)

结局指标

主要结局

Time required to complete cystoscopy

时间窗: 30 min

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

Time required to visualize ureteral jets

时间窗: 30 min

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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