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临床试验/NCT05069376
NCT05069376已完成不适用

Effect of Ureteral Stents Length and Location on Related Symptom

Taipei Medical University Shuang Ho Hospital2 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2018年6月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
103
试验地点
2
主要终点
Lower urinary tract symptom after placement of D-J stent

研究概览

简要总结

This is a prospective randomized clinical trial, evaluating the effect of the intra-ureteral placement of the stent's distal end versus the conventional stent placement on the postoperative LUTS and pain.

详细描述

Intravesical stent mass has been considered to cause stent-related symptoms, such as LUTS and pain. The current study hypothesized that the total intra-ureteral placement of the stent's distal end could decrease postoperative LUTS and pain. We proposed a prospective randomized trials, investigating the effect of intra-ureteral stent placement versus conventional stent placement. The primary end point was postoperative LUTS. The secondary end points were postoperative pain and quality of life. We used USSQ questionnaire as the assessing tool.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

Patients were not informed the allocation until the stent was removed.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of unilateral ureteral stone
  • Plan to undergo unilateral URS lithotripsy
  • Adult patients (>18 years old)

排除标准

  • Pre-stented cases
  • Distal ureteral stones
  • Preoperative urinary tract infection
  • With medications known to influence stent-related symptoms, including alpha-blockers, antimuscarinics, beta3-agonist
  • Pregnancy
  • Other procedures required during the procedure of lithotripsy
  • A stent was expected to be indwelled for more than 10 days (ureteral stricture, ureteral tumors/polyps, ureteral trauma, and a large amount of stone fragments)

结局指标

主要结局

Lower urinary tract symptom after placement of D-J stent

时间窗: Before removal of D-J stent

The symptoms are evaluated by a complete USSQ (Ureteral Stent Symptom Questionnaire) urinary index. The minimum and maximum values are 11 and 53, and the higher scores mean a worse outcome

次要结局

  • Pain after placement of D-J stent(Before removal of D-J stent)

研究者

发起方
Taipei Medical University Shuang Ho Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen-Hsun Ho

Doctor

Taipei Medical University Shuang Ho Hospital

研究点 (2)

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