Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, The University of North Carolina at Chapel Hill, Chapel Hill, NC.
Division of Women's Community and Population Health, Department of Obstetrics and Gynecology, Duke University School of Medicine, Durham, NC.
Am J Obstet Gynecol. 2022 Jan;226(1):100.e1-100.e6. doi: 10.1016/j.ajog.2021.08.055. Epub 2021 Sep 3.
Intraoperative evaluation of ureteral patency is often performed in gynecologic and urogynecologic surgery. Many agents are used to help assess the patency, each with its own associated cost, ease of use, and adverse reactions. Some agents, such as dextrose, are used as an instillation fluid to create a viscosity difference and aid the visualization of a ureteral jet. Others, such as oral phenazopyridine or the intravenous use of sodium fluorescein and indigo carmine, cause a color change of the urine to directly aid the visualization of ureteral jets. Recently, numerous studies have examined the efficacy and surgeon satisfaction of these agents. The studies have also emphasized certain options as associated with a lower cost. However, there have not been any cost studies comparing these agents.
To compare the cost-effectiveness of the following 4 agents that are commonly used in assessing ureteral patency intraoperatively: oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine.
We constructed a decision-analytic model to compare cystoscopy using oral phenazopyridine, dextrose instillation, intravenous sodium fluorescein, and intravenous indigo carmine. Failure to see efflux resulted in work-ups for ureteral obstruction. The probabilities were obtained from published studies, and the probability of successfully seeing efflux ranged from 0.92 with oral phenazopyridine to 0.99 with intravenous indigo carmine. The costs of the agents, adverse effects, and ureteral obstruction work-ups were obtained from the University of North Carolina at Chapel Hill Department of Pharmacy, the Healthcare Cost and Utilization Project 2016 database and the FAIR Health Consumer database. The cost of a ureteral obstruction work-up used in our model ranged from $9755 for intraoperative evaluation with retrograde pyelograms and stents to $29,034 for hospitalization. Our primary outcome was the incremental cost-effectiveness ratio per unnecessary work-up for ureteral obstruction avoided. Sensitivity analyses were performed to identify the key uncertainties.
Oral phenazopyridine, followed by an intravenous agent if needed, had a mean cost of $110 per patient. Dextrose averaged $151 more per patient, with only a slight improvement in avoiding unnecessary ureteral obstruction work-ups and a higher cost associated with adverse reactions (incremental cost-effectiveness ratio, $62,000). Intravenous agents cost approximately $1000 more per patient and were less effective at preventing unnecessary work-ups. Sensitivity analyses did not identify any thresholds that would significantly change the outcomes.
Our model suggests that oral phenazopyridine and dextrose instillation are the least expensive and the most effective agents to aid in the visualization of ureteral patency during intraoperative cystoscopy, although dextrose is associated with higher costs owing to a higher rate of adverse reactions (primarily urinary tract infections). Intravenous sodium fluorescein and indigo carmine are historically popular first-choice agents. However, they were found to be more expensive and less effective as primary agents in our model and should likely be reserved for use as secondary agents in the event that the visualization of ureteral jets is unclear with the initial use of phenazopyridine or dextrose.
在妇科和泌尿妇科手术中，常进行术中输尿管通畅性评估。有许多药物可用于帮助评估通畅性，每种药物都有其自身相关的成本、易用性和不良反应。一些药物，如葡萄糖，被用作灌注液，以产生粘度差异，并有助于可视化输尿管射流。其他药物，如口服 phenazopyridine 或静脉使用荧光素钠和靛胭脂，会使尿液变色，直接有助于可视化输尿管射流。最近，许多研究都检查了这些药物的疗效和外科医生满意度。这些研究还强调了某些选择与较低的成本相关。然而，尚未有任何成本研究比较这些药物。
比较术中评估输尿管通畅性时常用的 4 种药物的成本效益：口服 phenazopyridine、葡萄糖灌注、静脉注射荧光素钠和静脉注射靛胭脂。
我们构建了一个决策分析模型，比较了使用口服 phenazopyridine、葡萄糖灌注、静脉注射荧光素钠和静脉注射靛胭脂进行膀胱镜检查的情况。如果未能观察到流出物，将进行输尿管梗阻的检查。概率来自已发表的研究，成功观察到流出物的概率范围从口服 phenazopyridine 的 0.92 到静脉注射靛胭脂的 0.99。药物的成本、不良反应和输尿管梗阻检查的费用从北卡罗来纳大学教堂山分校药学院、医疗保健成本和利用项目 2016 数据库和 FAIR Health 消费者数据库获得。我们模型中输尿管梗阻检查的成本范围从术中评估时逆行肾盂造影和支架的 9755 美元到住院治疗的 29034 美元。我们的主要结果是每避免一次不必要的输尿管梗阻检查的增量成本效益比。进行了敏感性分析以确定关键的不确定性。
口服 phenazopyridine，如果需要，再静脉注射一种药物，每位患者的平均费用为 110 美元。葡萄糖每位患者平均增加 151 美元，虽然避免不必要的输尿管梗阻检查的效果略有改善，但不良反应相关成本更高（增量成本效益比为 62000 美元）。静脉内药物每位患者的费用增加约 1000 美元，并且在预防不必要的检查方面效果较差。敏感性分析没有发现任何会显著改变结果的阈值。
我们的模型表明，口服 phenazopyridine 和葡萄糖灌注是最经济和最有效的辅助术中膀胱镜检查评估输尿管通畅性的药物，尽管葡萄糖由于不良反应（主要是尿路感染）发生率较高而导致成本更高。静脉注射荧光素钠和靛胭脂是历史上流行的首选药物。然而，在我们的模型中，它们被发现作为主要药物更昂贵且效果较差，因此应该保留在使用 phenazopyridine 或葡萄糖初始观察输尿管射流不清晰的情况下作为二线药物。
