The Effect of Naftopidil for the Double-J Stent Discomfort: Multicenter, Randomized, Double-blind, Placebo Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score
研究概览
简要总结
This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.
详细描述
-
Enrollment
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patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
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patients aged more than 20 years
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Randomization
-
naftopidil 75 mg qd or placebo until Double-J stent removal
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Standard treatment with pain-killers on demand were also applied.(aceclofenac)
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Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients to be undergone double-J stent indwelling
- •>= 20 years
- •undergoing unilateral retrograde double J (DJ) stent placement planned for 5-15 days indwelling
排除标准
- •after percutaneous nephrolithotomy, open or laparoscopic ureterolithotomy presence of ureteral stone
- •renal insufficiency (serum Cr > 1.4)
- •febrile urinary tract infection (fever > 38.0°C, evidence of urinary infection )
- •pregnancy or breast feeding
- •solitary kidney
- •hypersensitivity to Naftopidil
- •current use of any alpha blocker, calcium channel blocker, corticosteroid moderate or sever cardiovascular or cerebrovascular disease
- •hepatic dysfunction
- •prior history of pelvic surgery or irradiation
- •prior history of transurethral resection of bladder tumor or prostate surgery
- •significant active medical illness which in the opinion of the investigator would preclude protocol treatment
- •genetic disorder such ad galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
研究组 & 干预措施
Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
干预措施: Naftopidil (Drug)
Naftopidil
This interventional group will receive analgesics and naftopidil 75mg po qd.
干预措施: Standard treatment (Drug)
Control groups with only analgesics
Control groups will receive only analgesics
干预措施: Placebo for Naftopidil (Drug)
Control groups with only analgesics
Control groups will receive only analgesics
干预措施: Standard treatment (Drug)
结局指标
主要结局
Ureteral Stent Symptom Questionaire(USSQ) urinary symptom score
时间窗: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
DJ stent removal should be done between study day 5 and 15.
USSQ body pain score
时间窗: at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days)
次要结局
- International Prostate Symptom Score(IPSS), QoL score(at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days))
- USSQ work performance score(at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days))
- USSQ sexual matters score(at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days))
- USSQ general health score(at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days))
- Total analgesics use(at the day of DJ stent removal, an expected average of 10 days (range: 5-15 days))
研究者
Chang Wook Jeong
M.D, Ph.D.
Seoul National University Hospital