Evaluation of Quality of Life in Patients After Placement of a Modified Double J Ureteral Stent. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- ureteral reflux
研究概览
简要总结
Double-J (DJ) stents are commonly inserted after ureteroscopy. There are several complications associated with the presence of DJ stent: urinary tract infection, stent encrustation, stent migration, and stent-related symptoms (SRS).
SRS occur in up to 80% of patients and include pain, hematuria, and dysuria, all of which negatively impact the patient's quality of life.
Physicians proposed the distal end of the ureteral stents might involve in SRS by over-simulating the trigone of bladder. The design of the distal end, made with a thinner loop than that of a standard DJ stent, is intended to mitigate SRS and reduce urine reflux.
详细描述
Study Design:
Prospective, randomized, open-label, controlled trial with two parallel arms.
Study Center:
Department of Urology, St. Luke's Clinical Hospital, St. Petersburg, Russia
Study Population:
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
- Double (Participant, Investigator)
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 18 years and older
- •Patients with kidney stones
- •Patients with ureteral stones
排除标准
- •Congenital anomalies of the urinary tract
- •Urinary tract infections
- •Upper urinary tract obstruction
- •Complicated ureteroscopy (e.g., ureteral perforation)
- •Pregnancy
- •Pre-stented patients
结局指标
主要结局
ureteral reflux
时间窗: Intraoperative
Injection of raradiopaque dye using gravity- filling cystogram followed by X-ray imaging. If contrast entered or not entered the ureter and kidney, ureteral reflux was considered positive or not, respectively.
Assessment the Ureteral Stent Symptom Questionnaire (USSQ)
时间窗: Postoperative: 1st and 7th day, before stent removal
Ureteral stent symptom questionnaire (USSQ) a psychometrically valid measure to evaluate symptoms and impact on quality of life of ureteral stents. USSQ contains 38 questions and 2 visual analog scales (VAS), allowing assessment of the severity of SRS and their impact on the patient's quality of life. The questions are grouped into 6 domains: Urinary symptoms Pain General health Work performance Sexual matters Additional problems For each domain, a score index is calculated as the sum of the points from all questions in that domain. The scale scores range from 1 to 10, with higher values indicating more severe SRS and lower quality of life.
次要结局
- Patient's height(Preoperative)
- Patient's weight(Preoperative)
- Body mass index (BMI)(Preoperative)
- Operative time(Intraoperative (measured from start to end of procedure))
- Surgery(Preoperative)
研究者
Mikheev Yury
Urologist
St. Luke's Clinical Hospital, Russia