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硅胶与聚氨酯输尿管支架比较:一项前瞻性对照研究。

Comparison of silicone versus polyurethane ureteral stents: a prospective controlled study.

机构信息

Department of Urology, Pavlov First Saint Petersburg State Medical University, Saint Petersburg, Russia.

Department of Urology, State University of Medicine and Dentistry, Moscow, Russia.

出版信息

BMC Urol. 2020 Feb 3;20(1):10. doi: 10.1186/s12894-020-0577-y.

Abstract

BACKGROUND

Approximately 80% of patients with indwelling ureteral stents experience stent related symptoms (SRS). We believe SRS can be reduced through altering the composition of ureteral stents to a less firm material. Therefore, we aim to compare modern silicone and polyurethane ureteral stents in terms of SRS intensity and safety.

METHODS

From June 2018 to October 2018, patients from two distinct clinical centers were prospectively enrolled in the study and stratified (non-randomly) into either control group A, patients who received polyurethane stents (Rüsch, Teleflex), or experimental group B, patients who received silicone stents (Cook Medical). Each participant completed a survey 1 h after stent insertion, in the middle of the stent dwelling period, and before stent removal or ureteroscopy noting body pain and overactive bladder via the visual analog scale pain (VASP) and overactive bladder (OAB) awareness tool, respectively. Additionally, successfulness of stent placement, hematuria, number of unplanned visits, and stent encrustation rates were assessed within each group.

RESULTS

A total of 50 patients participated in the study, control group A consisted of 20 patients and experimental group B consisted of 30 patients. Participants in group B, silicone ureteral stents, demonstrated significantly lower mean values of VASP 2 weeks prior to stent removal and promptly before stent removal (p = 0.023 and p = 0.014, respectively). No other comparisons between the two groups were statistically significant.

CONCLUSIONS

Compared to polyurethane ureteral stents, silicone ureteral stents are associated with lower body pain intensity assessed by VASP 2 weeks before stent removal and at the time of stent removal.

TRIAL REGISTRATION

Current Controlled Trials NCT04000178. Retrospectively registered on June 26, 2019.

摘要

背景

大约 80%留置输尿管支架的患者会出现支架相关症状(SRS)。我们认为,通过将输尿管支架的组成材料改为较软的材料,可以减少 SRS。因此,我们旨在比较现代硅胶和聚氨酯输尿管支架在 SRS 强度和安全性方面的差异。

方法

2018 年 6 月至 2018 年 10 月,来自两个不同临床中心的患者前瞻性地入组研究,并分为对照组 A(接受聚氨酯支架[Rüsch,Teleflex]的患者)和实验组 B(接受硅胶支架[Cook Medical]的患者)。每个参与者在支架置入后 1 小时、支架留置中期和支架取出或输尿管镜检查前完成一项调查,通过视觉模拟量表疼痛(VASP)和膀胱过度活动症(OAB)意识工具分别记录身体疼痛和膀胱过度活动症(OAB),并评估每个组中的支架放置成功率、血尿、计划外就诊次数和支架结垢率。

结果

共有 50 名患者参与了这项研究,对照组 A 有 20 名患者,实验组 B 有 30 名患者。实验组 B 患者,即硅胶输尿管支架组,在支架取出前 2 周和取出前即刻的 VASP 平均值显著较低(p=0.023 和 p=0.014)。两组之间的其他比较均无统计学意义。

结论

与聚氨酯输尿管支架相比,硅胶输尿管支架在支架取出前 2 周和取出时通过 VASP 评估的身体疼痛强度较低。

试验注册

当前对照试验 NCT04000178。于 2019 年 6 月 26 日回顾性注册。

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