Assessing the impact of ureteral stent design on patient comfort.
Assessing the impact of ureteral stent design on patient comfort.
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DOI：
10.1016/j.juro.2009.02.019
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发表时间：
2009-06
期刊：
影响因子：
--
通讯作者：
Comfort Study Team
中科院分区：
文献类型：
--
作者：
Lingeman JE;Preminger GM;Goldfischer ER;Krambeck AE;Comfort Study Team
本研究评估了新设计的输尿管研究支架或市售对照支架（Polaris™、Percuflex Plus®）的近期舒适度。研究支架用≤3Fr环替代远端6 Fr猪尾末端。假设原位减少材料以提高舒适度。评估了患者自填输尿管支架症状问卷（USSQ）的效用。这项4组、多中心研究入组了需要逆行单侧输尿管支架植入4-28天的成人。在放置前（基线）、放置后第4天和取出后第30天进行USSQ给药。236例患者随机分组（1：1：1：1的比例）：短环尾（n=60）、长环尾（n=59）、Percuflex Plus（n=64）和Polaris（n=53）。总体而言，疼痛从基线-第4天恶化，从第4天-第30天改善。所有支架的平均止痛药使用量在置入后第1天达到峰值。常见器械相关症状的严重程度为轻度或中度，包括胁腹疼痛（n=47例患者）、血尿（n=39）、排尿困难（n=34）、尿频（n=30）和尿急（n=27）。6例患者发生了9起需要住院治疗的器械相关不良事件。所有不良事件均消退，大多数在住院治疗后3天内消退。尽管无统计学显著性，但植入短环尾支架的患者在置入后第4天的USSQ疼痛评分较低，在置入后第1天的止痛药使用量较低，此时所有支架组的疼痛均达到峰值，表明原位材料较少可能会改善输尿管支架的舒适度，尤其是疼痛。USSQ可能更适合于支架植入和非支架植入患者的长期比较，而不是短期输尿管支架试验。
This study assessed near-term comfort of newly designed ureteral study stents or marketed control stents (Polaris™, Percuflex Plus®). Study stents substituted distal 6Fr pigtail ends with ≤3Fr loops. Reduced material in situ was hypothesized to enhance comfort. Utility of the patient self-administered Ureteric Stent Symptoms Questionnaire (USSQ) was assessed. This 4-arm, multicenter study enrolled adults requiring retrograde unilateral ureteral stent placement for 4–28 days. USSQ administration occurred prior to placement (Baseline), at Day 4 post-placement, and Day 30 post-removal. 236 patients were randomized (1:1:1:1 ratio): Short Loop Tail (n=60), Long Loop Tail (n=59), Percuflex Plus (n=64); and Polaris (n=53). Overall, pain worsened from Baseline-Day 4 and improved from Day 4-Day 30. Mean pain medication usage peaked for all stents at Day 1 post-placement. Common device-related symptoms were mild or moderate in severity including flank pain (n=47 patients), hematuria (n=39), dysuria (n=34), frequent urination (n=30), and urinary urgency (n=27). Six patients experienced 9 device-related adverse events requiring hospitalization. All adverse events resolved, most within 3 days of in-patient treatment. Although not statistically significant, patients stented with the Short Loop Tail had lower USSQ pain scores at Day 4 post-placement and lower pain medication usage at Day 1 post-placement, when pain peaked for all stent groups, suggesting that ureteral stent comfort, especially pain, may be improved with less material in situ. The USSQ may be better suited for longer-term comparisons among stented and non-stented patients rather than in this short term ureteral stent trial.
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