Soft Vs. Firm Ureteral Stents: Symptoms Improvement Without Affecting Outcomes- a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- the Ureteral stent symptoms questionnaire (USSQ )index score
研究概览
简要总结
The goal of this clinical trial is to evaluate whether ureteral stent type impacts stent-related symptoms and quality of life in patients undergoing ureteroscopy (URS) and stone lithotripsy for ureteral stones. The main questions it aims to answer are:
- Does a soft polymer stent reduce stent-related symptoms compared to a firm polymer stent?
- Does stent type affect intra- and postoperative complications? Researchers will compare patients receiving a soft polymer stent (Universa®, Cook Medical) to those receiving a firm polymer stent (Percuflex®, Boston Scientific) to determine if soft stents improve patient comfort and quality of life while maintaining a similar safety profile.
Participants will:
- Undergo URS and stone lithotripsy for ureteral stones.
- Be randomly assigned to receive either a soft or firm ureteral stent.
- Complete the Ureteral Stent Symptoms Questionnaire (USSQ) upon stent removal, 14 days after URS.
详细描述
Study Design and Patient Selection
- Study Period and Ethical Approval:
- Conducted between July 2023 and July 2024 following institutional review board approval (SMC 0119-23).
- Informed consent obtained from all participants.
- Adhered to the Declaration of Helsinki.
- Stent Types and Randomization:
- Soft stent: Universa® (Cook Medical).
- Firm stent: Percuflex™ Plus (Boston Scientific).
- Randomization in a 1:1 ratio using asymptomatic maximal randomization.
Surgical Technique and Intervention Operative Team included three fellowship-trained endourologists.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged over 18 years
- •ureteral stones measuring up to 2cm requiring URS and laser lithotripsy
排除标准
- •pediatric patients
- •bilateral stones requiring bilateral URS and laser lithotripsy,
- •stone located in the renal pelvis or calyces,
- •intra-operative complications of any kind,
- •any residual stones during the procedure,
- •ureteroscopies in which no stones were treated ("white ureteroscopy").
结局指标
主要结局
the Ureteral stent symptoms questionnaire (USSQ )index score
时间窗: 14 days after stent insertion
The summation of the Ureteral stent symptoms questionnaire (USSQ) individual question scores. The questionnaire includes 32 questions, with a scale of zero to five points each. The USSQ Index score represents the summation of each indivisual question score, with a scale of 0-160, with higher score means the patients is suffering from more severe symptoms.
次要结局
- Ureteral stent symptoms questionnaire (USSQ) urinary domain score(14 days after stent insertion)
- Ureteral stent symptoms questionnaire (USSQ) pain domain score(14 days after stent insertion)
- Ureteral stent symptoms questionnaire (USSQ) general health domain score(14 days after stent insertion)
- Ureteral stent symptoms questionnaire (USSQ) work performance domain score(14 days after stent insertion)
- Ureteral stent symptoms questionnaire (USSQ) sexual performance domain score(14 days after stent insertion)
研究者
Dr. Orel Hemo
Urology Resident
Sheba Medical Center