Dellis Athanasios E, Papatsoris Athanasios G, Keeley Francis X, Bamias Aristotelis, Deliveliotis Charalambos, Skolarikos Andreas A
1 Second Department of Surgery, School of Medicine, Aretaieion Hospital, National and Kapodistrian University of Athens , Maroussi, Greece .
2 Second Department of Urology, School of Medicine, Sismanogleion Hospital, National and Kapodistrian University of Athens , Maroussi, Greece .
J Endourol. 2017 Jan;31(1):100-109. doi: 10.1089/end.2016.0663. Epub 2016 Nov 29.
To properly use the Ureteric Symptom Score Questionnaire (USSQ) to evaluate, in a randomized control study, the effect of tamsulosin, solifenacin, and their combination in improving symptoms and quality of life in patients with indwelling ureteral stents.
After institutional review board approval, 260 patients with a ureteral stent were randomly assigned to receive tamsulosin 0.4 mg, solifenacin 5 mg, or placebo and further randomized to receive their combination. The validated USSQ was completed 1 and 4 weeks after stent insertion and 4 weeks after stent removal. Kruskal-Wallis test, chi-squared test (or Fisher's exact test), one-way analysis of variance, and T-test (or Wilcoxon rank-sum test if not normal data) were used for statistical analysis. The results were considered significant at p < 0.05.
Patients receiving tamsulosin or solifenacin expressed significantly lower urinary (p < 0.001), pain (p < 0.001 with stent in situ), and general health index (p = 0.002 in first and p < 0.001 in fourth week with stent in situ) scores. Sexual life and quality of work were also positively influenced. Patients on combination therapy expressed lower urinary (p < 0.001) and pain (p < 0.001) scores in the fourth week with stent in situ and work performance in the first week and with stent in situ (p = 0.001) and after stent removal (p = 0.005). No patients had to discontinue medication due to side effects.
Stent-related morbidity is a reality in the majority of patients. Simple medication, such as tamsulosin and solifenacin alone or in combination, improves stent-related symptoms and has a positive impact on quality of life.
在一项随机对照研究中，正确使用输尿管症状评分问卷（USSQ）来评估坦索罗辛、索利那新及其联合用药对改善留置输尿管支架患者症状和生活质量的效果。
经机构审查委员会批准后，260例输尿管支架置入患者被随机分配接受0.4毫克坦索罗辛、5毫克索利那新或安慰剂治疗，并进一步随机分组接受联合用药。在支架置入后1周和4周以及支架取出后4周完成经过验证的USSQ。采用Kruskal-Wallis检验、卡方检验（或Fisher精确检验）、单因素方差分析和T检验（若数据非正态则采用Wilcoxon秩和检验）进行统计分析。结果在p < 0.05时被认为具有显著性。
接受坦索罗辛或索利那新治疗的患者在排尿（p < 0.001）、疼痛（支架在位时p < 0.001）和总体健康指数（支架在位时第一周p = 0.002，第四周p < 0.001）方面的评分显著更低。性生活和工作质量也受到积极影响。联合治疗的患者在支架在位第四周时排尿（p < 0.001）和疼痛（p < 0.001）评分更低，在第一周以及支架在位时（p = 0.001）和支架取出后（p = 0.005）工作表现更好。没有患者因副作用而不得不停药。
支架相关发病率在大多数患者中是现实存在的。简单的药物治疗，如单独使用坦索罗辛和索利那新或联合使用，可改善与支架相关的症状，并对生活质量产生积极影响。
