Comparison of Stent Related Symptoms Between Regular Double J Stent Versus Comfi J Stent: A Single Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Stent related symptom
研究概览
简要总结
A prospective, single-blinded, randomized controlled trial conducted at a single center to compare stent related symptoms between two different stents using Ureteral Stent Symptom Questionnaire (USSQ) scores , Visual Analog Scale (VAS) pain scores.
详细描述
Ureteral stents are widely used in urology following retrograde intrarenal surgeries and ureteric lithotripsy and other endourological procedures. However, their use is associated with significant discomfort, infections, and reduced quality of life (QoL). Over time, different materials and designs have been developed to improve stent performance and reduce complications. This study aims to compare the stent-related symptoms (SRS) of two types of ureteral stents: the regular Double J stent and the Comfi J stent.
Objectives of the study-
- Compare Ureteral Stent Symptom Questionnaire (USSQ) scores between the two stents.
- Compare Visual Analog Scale (VAS) pain scores.
- Assess complications associated with each stent.
- Evaluate the difficulty of stent insertion.
Study Design & Methods: A prospective, single-blinded, randomized controlled trial conducted at a single center. Sample Size: 100 patients undergoing retrograde intrarenal surgery, ureteroscopic lithotripsy
Randomization: Intraoperative, using a computer-generated sequence, block randomization Assessments: USSQ and VAS scores at post-operative days (POD) 1, 7, and 14.
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)
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
- •Eligible participants were adult patients (aged 18-80 years) who underwent unilateral retrograde ureteroscopy (URS) lithotripsy for stone disease
- •Retrograde intrarenal surgery (RIRS) lithotripsy with planned ureteric stent insertion for urinary tract stones
排除标准
- •Concomitant use of a-blockers, anticholinergics, corticosteroids, calcium channel blockers, and analgesics
- •Undergoing percutaneous nephrolithotomy, open ureteric surgery or laparoscopic ureteric surgery, including ureterolithotomy
- •Neurogenic bladder, Overactive bladder syndrome, and neurological and psychiatric diseases
- •Preoperative febrile Urinary Tract Infection (UTI)
- •Pregnancy or breastfeeding;
- •A single kidney
- •Moderate or severe cardiovascular or cerebrovascular disease
- •Hepatic dysfunction
- •History of pelvic surgery or irradiation
- •History of bladder or prostate surgery
- •Other acute medical conditions (including acute pancreatitis, acute gastroenteritis, musculoskeletal disorders) that might influence the USSQ pain score
- •Allergy to any medication
结局指标
主要结局
Stent related symptom
时间窗: 2 weeks
Comparison of Ureteral Stent Symptom Questionnaire (USSQ) scores between regular Double J stent and Comfi J stent at postoperative day 1, 7, and 14. Higher Scores means greater severity of the symptoms.
次要结局
- Complication rates(before 2 weeks)
研究者
Anil Shrestha
Professor Dr.
Bir Hospital