A Prospective Multicenter Clinical Trial to Evaluate the Comfort of the Percuflex Helical Ureteral Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Percent of patients who have pain during the stent indwell period
研究概览
简要总结
The Boston Scientific Helical Stent is a unique stent designed to improve flexibility and comfort. It is designed to conform more to the shape of the ureter (hollow tube connecting the kidney and the bladder) to ultimately improve patient comfort and decrease the need for painkillers.
详细描述
Ureteral stents have been used for many years for a variety of clinical indications. Many surgeons routinely use ureteral stents after the endourologic removal of stones to facilitate in urine passage and facilitate excretion of any left over stones. There is a multitude of literature that reveals that most patients find ureteral stents to be uncomfortable. This discomfort often causes pain severe enough that patients anxiously anticipate stent removal, and often request early stent removal, and/or require use of pain medications that have many side effects and cause further discomfort to these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; female patients must be sterile, post-menopausal or willing to use birth control during the course of the study
- •19 years of age and older
- •Having undergone Shockwave Lithotripsy-SWL, or a diagnostic ureteroscopy or uncomplicated ureteroscopy for stone removal requiring retrograde placement of a ureteral stent for an anticipated duration of between 2 and 21 days
- •Willing to sign the Informed Consent Form
- •Able to read, understand, and complete patient questionnaires
排除标准
- •Active, symptomatic urinary tract infection
- •Non-stone related distal ureteral obstruction or stricture
- •Clinically significant trauma or significant retained stone burden that could significantly contribute to patient discomfort
- •Ureteral perforation or trauma
- •History of bladder reconstruction or interstitial cystitis
- •Spinal cord injuries
- •Pregnant or lactating females
- •Non-stone related voiding dysfunction requiring supplemental bladder drainage tubes for more than 24 hours post operatively
- •Patients with a solitary kidney
- •Chronic use of pain or anti-spasmodic medication for symptoms other than stone related pain
- •If in the opinion of the Investigator, the patient is not a suitable study candidate.
研究组 & 干预措施
Helical stent insertion
Study participants will receive the helical stent
干预措施: Stent insertion (Device)
结局指标
主要结局
Percent of patients who have pain during the stent indwell period
时间窗: 1-2 weeks
The primary objective is to decrease the percent of patients who have pain during the stent indwell period beyond protocol-defined postoperative pain therapy from 25% for standard stents (the Control Stent in previous studies) to 10% for the Helical Stent. The previous clinical trial found that patients with Percuflex Plus stents had pain 25.2% of the time following stent insertion (J Urol 183:1037, 2010).
次要结局
- Percent of patients requesting intervention during the stent indwell period(1-2 weeks)
研究者
Ben Chew, MD
Associate Professor
University of British Columbia