NCT02424149已完成不适用
Use of Phenazopyridine for Confirmation of Ureteral Patency During Intraoperative Cystoscopy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
研究概览
简要总结
In this prospective, randomized trial subjects will be randomized to receive phenazopyridine or no medication prior to pelvic reconstructive procedures that use cystoscopy to confirm ureteral patency intraoperatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Females only
- •Planned surgical procedure where cystoscopy will be used to document ureteral urine flow
- •Age > or = 18 years, no upper age limit
- •Able and willing to consent
排除标准
- •Planned surgical procedure where cystoscopy will not be used
- •Planned surgical procedure where cystoscopy is used for a purpose other than documenting ureteral urine flow
- •age <18 years
- •pregnancy
- •unable/unwilling to participate
- •history of allergy or adverse reaction to phenazopyridine
- •hepatic dysfunction
- •known phenazopyridine hypersensitivity
- •history of urologic surgery
- •presence of ureteral stents prior to the planned surgical procedure
- •concomitant suprapubic catheter placement
研究组 & 干预措施
Phenazopyridine
Experimental
Preoperative phenazopyridine
干预措施: Phenazopyridine (Drug)
结局指标
主要结局
Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room
时间窗: Day of surgery
Timing was performed in the operating room. Time to visualize urine efflux was started at insertion of the cystoscope into the bladder, the time was considered complete when both ureteral orifices had displayed urine efflux.
次要结局
- Physician Confidence Measured by a Survey(day of surgery (day 0))
- Additional Interventions: Measured by Use of IV Fluids, IV Lasix, IV Methylene Blue, or Ureteral Stent Placement in OR(day of surgery (day 0))
- Post-operative Urethral Discomfort Measured by Pain Scales(post operative day 1)
- Trial of Void Results(Day of hospital discharge)
研究者
研究点 (1)
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