Phase One of Study on Urinary Stent Complications and Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Lower Urinary Tract Symptoms (LUTS)
研究概览
简要总结
The aim of the investigators study is to evaluate whether alpha-blockers such as terazosin and anti-cholinergics such as tolterodine can be relieve the DJ-stent related symptoms.
详细描述
Ureteral stent (US) has been as essential tool in the urologist's surgeries and is useful instruments that its indications increase due to new stent technologies and improvement of patient's comfort.
US associated with discomfort complications that include lower urinary tract symptoms (LUTS) as frequency, urgency, dysuria, incomplete emptying, flanks and suprapubic's pain, incontinence, hematuria, movement of stent, infection and encrustation of stent. US related symptoms are as same as LUTS due to benign prostate hyperplasia and overactive bladder which relieve with alpha-blockers and anticholinergic. The purpose of our study is to investigate the effect of terazosin and tolterodine lonely and together in comparison of placebo on US related symptoms.
The investigators study will be done prospectively. The patients who underwent indwelling Double-j stent distributed into four groups: 1)receive placebo 2)receive terazosin 2mg twice 3)receive tolterodine 2mg daily 4) receive terazosin 2mg twice and tolterodine 2mg daily. All of the patients receive prophylactic antibiotic and on demand analgesic. After entrance to study, they fulfill the International Prostatic Symptoms Score (IPSS) and Visual Analog Scale (VAS) on the before indwelling US, two weeks after indwelling US and US removal time, then the investigators will evaluate the drug's effect on US related symptoms.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •If a patient does not meet any exclusion criteria and to be undergone double-J stent indwelling.
排除标准
- •Prior history of pelvic surgery
- •Prior history of Transurethral Resection of the either Prostate or Bladder Tumor
- •Benign prostate hyperplasia
- •Recent or recurrent urinary tract infection
- •Chronic medication with beta-blockers or Anti-cholinergic
- •Prostatitis
- •Prostate cancer
- •Bilateral ureteroscopy or ureteral stenting
- •Age < 18 and > 55
- •Stone size > 20 mm
- •Bladder Outlet Obstruction
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Terazosin
干预措施: Terazosine (Drug)
Tolterodine
干预措施: Tolterodine (Drug)
Tolterodine + Terazosin
干预措施: Tolterodine + Terazosin (Drug)
结局指标
主要结局
Lower Urinary Tract Symptoms (LUTS)
时间窗: Expected average of 2 weeks
LUTS was evaluated using the International Prostate Symptom Score (IPSS) questionnaire perioperatively. The IPSS constitutes of seven questions assigned score from 0 to 5 to evaluate the severity of LUTS in patients. Total scoring of IPSS ranges from 0 to 35, asymptomatic to very symptomatic. The more the score on scale is, the worse the outcome is.Therefore, the higher values represent worse outcomes.
次要结局
- Quality of Life(Expected 2 weeks later)