跳至主要内容
临床试验/NCT03257306
NCT03257306Unknown不适用

Magnetic Ureteral Stent Symptoms - a Comparison to Standard Ureteral Stent as Perceived By the Patient (MAGUSS)

Turku University Hospital4 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2018年11月9日最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
试验地点
4
主要终点
Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)

研究概览

简要总结

The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents. If this hypothesis would be confirmed then the usage of magnetic ureteral stents would be justified for both reducing patient discomfort by way of fewer cystoscopies and possibly also decreasing the overall expenditures of treatment.

详细描述

Many urological procedures involving the kidney and the ureters require a stent replacement to avoid un-wanted adverse invents caused by the procedure itself. The stenting, however, predisposes the patient to adverse effects of its own and the application and removal of the stent is a notable monetary expense. The use of magnetic ureteral stents that can be removed via catheter instead of requiring an additional cystoscopy for removal would reduce the discomfort to patients and also possibly decrease the expenditures of the overall treatment. However, the comparability of standard ureteral stents and the magnetic ureteral stents is largely unknown due to there being no published research on the subject as of this time. The specific aim of this study is to validate our hypothesis that the magnetic ureteral stents have the same amount of adverse effects as the more commonly used non-magnetic ureteral stents.

The design is as prospective randomized, single-blinded, multi-institutional, non-inferiority study conducted in Hospital Districts of Southwest Finland, Päijät-Häme, Pohjois-Savo, Satakunta and Keski-Suomi. Using age and gender stratification, patients are randomised 1:1 fashion into having a magnetic (n=85) or standard ureter stent (n=85). The primary objectives are the mean differences between the two groups in pain and urinary symptoms scores determined by the Ureteral Stent Symptom Questionnaire (USSQ) 4 weeks after stent placement.

The patients will be recruited starting from the 4rd quarter of 2018 and ending during the 3rd quarter of 2020. Preliminary analysis of all results will be available in September 2020 and reports are expected to be written during December 2020.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Language spoken: Finnish
  • Clinically evaluated need for short term ureter stenting in course of extracorporeal shockwave lithotripsy-treatment or after pyeloscopy
  • Mental status: Patients must be able to understand the meaning of the study
  • Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff

排除标准

  • Current use of alpha blockers
  • Patients undergoing emergency ureteroscopy and stenting
  • Patients with a long term ureter stents
  • Any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist

结局指标

主要结局

Change in Pain score in Ureteral Stent Symptom Questionnaire (USSQ)

时间窗: 4 weeks after stent placement and 4 weeks after stent removal

4 weeks after stent placement. \[5\] Less than 5 points of difference between the two study groups is considered as clinically insignificant.

次要结局

  • General health score in Ureteral Stent Symptom Questionnaire (USSQ)(4 weeks after stent placement and 4 weeks after stent removal)
  • Sexual score in Ureteral Stent Symptom Questionnaire (USSQ)(4 weeks after stent placement and 4 weeks after stent removal)
  • Urinary symptom score in Ureteral Stent Symptom Questionnaire (USSQ)(4 weeks after stent placement and 4 weeks after stent removal)
  • Working performance score in Ureteral Stent Symptom Questionnaire (USSQ)(4 weeks after stent placement and 4 weeks after stent removal)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Kari Syvanen

Principal Investigator

Turku University Hospital

研究点 (4)

Loading locations...

相似试验