Comparison Between Symptomps Related to Pigtail Suture Stent Versus Conventional Double J After Ureterorenoscopy for Stone Treatment. A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Urinary Symptom Index Score
研究概览
简要总结
Double J ureteral stents (DJ) are widely used in urological practice and commonly inserted after most of ureteroscopies. Stent-related symptoms (SRS) represent a major issue. Many research lines have been explored with the aim of decreasing SRS: Vogt et al. projected a self-made pigtail suture stent (PSS) replacing the distal pigtail with a 0.3 Fr suture reaching the bladder, showing decreased SRS and good tolerance. To date, these promising results hasn't been confirmed by a prospective randomized controlled trial (RCT) involving a marketed PSS. Thus, we designed a prospective single-blind RCT to compare SRS caused by marketed PSS and conventional DJ after uncomplicated URS for stone treatment.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ureteral or renal stones < 2 cm needing treatment through semirigid or flexible URS and laser lithotripsy
- •stone-free procedure and absence of intraprocedural complications
- •WHO performance status 0-2
排除标准
- •significant residual fragments at the end of the procedure
- •intraprocedural complications (e.g. ureteral damage or stricture)
- •indwelling double J stent
- •acute kidney failure
- •urinary tract infection
- •urinary tract abnormalities
- •pathologies or medications potentially influencing voiding pattern and pain perception
结局指标
主要结局
Urinary Symptom Index Score
时间窗: 14 days
to compare Urinary Symptom Index Score (sum of USSQ Urinary symptoms scores) of suture stent and double J group, 2 weeks after surgery.
次要结局
- complications and adverse events(2 weeks)
- USSQ single answers(2 days)
- USSQ domains' scores(2 days)
- 2 weeks USSQ domains' subscores adjusted for baseline(6 weeks)
研究者
Andrea Bosio
MD Urologist, PhD
A.O.U. Città della Salute e della Scienza