Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study
Effects of Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing Flexible Ureteroscopy for Kidney Stone: A Randomized Multicenter Clinical Study
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DOI：
10.1097/ju.0000000000001098
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发表时间：
2020-10-01
影响因子：
6.6
通讯作者：
Traxer, Olivier
中科院分区：
文献类型：
--
作者：
Wiseman, Oliver;Ventimiglia, Eugenio;Traxer, Olivier
目的：我们对软性输尿管镜治疗结石后患者的舒适度和生活质量进行了为期5周的多中心、单盲、前瞻性、随机的多中心、单盲、前瞻性、随机试验。主要结果是在双J(R)支架取出前(D)20天记录输尿管支架症状问卷(USSQ)体痛指数，次要终点是中间日期(D2、D7、D20)和支架取出后2周(D35)的USSQ评分、不良事件的发生和支架植入。结果：113例(80.1%)患者完成试验。硅胶支架植入后20天的平均(SD)身体疼痛评分为18.7分(11.4分)比25.1分(14.2分)低25%(p=0.015)。在不良事件和安全性方面没有观察到差异。硅胶支架组在D2、D7和D20时的USSQ尿路症状评分较低，分别为26.4分(7.7分)和31.8分(8.1分)(p<；0.001)。USSQ自我问卷的使用与遗漏或不完整答案的数量有限相关。结论：这项大样本前瞻性随机对照研究的初步结果显示，硅胶支架与Percuflex Plus支架相比，患者的不适感明显减少。我们建议将其用于需要支架治疗结石疾病的患者。
Purpose: We compared the hydrocoated silicone stent (Coloplast Imajin (R) hydro) to Percuflex (TM) Plus stent (Boston Scientific) in terms of patient comfort and quality of life after flexible ureteroscopy for stone disease over a 5-week prospective followup.Materials and Methods: This is a multicenter, single-blind, prospective, randomized trial of 141 patients treated with flexible ureteroscopy for renal stones. Primary outcome was Ureteral Stent Symptom Questionnaire (USSQ) Body Pain Index recorded before Double-J (R) stent removal at day (D) 20. Secondary end-points were USSQ scores at intermediate dates (D2, D7, D20) and 2 weeks after stent withdrawal (D35), occurrence of adverse events and stent encrustation.Results: The trial was completed by 113 (80.1%) patients. Mean (SD) USSQ body pain scores were 25% lower at D20 for the silicone stent at 18.7 (11.4) vs 25.1 (14.2) (p=0.015). No difference in terms of adverse events and safety profile was observed. USSQ urinary symptoms scores at D2, D7 and D20 were lower in the silicone stent group at 26.4 (7.7) vs 31.8 (8.1) at D20 (p < 0.001). The use of USSQ self-questionnaires was associated with a limited number of missing or incomplete answers.Conclusions: The primary results of this large sample prospective randomized controlled study comparing the silicone Imajin hydro stents to the Percuflex Plus stent show that silicone stents are associated with significantly less patient discomfort. We would recommend their use in patients who require stenting for stone disease.