Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Average durability of the stent MEMOKATH ® 051
研究概览
简要总结
TOTEME offers to treat certain chronic strictures of the ureter with MEMOKATH 051 to assess its effectiveness, tolerance and mean durability during a 3 years follow up period.
Patients usually treated with double J stents will be included. The double J stent will be replaced by a MEMOKATH 051 stent under general anesthesia during a cystoscopy. After this procedure, the patients will have medical examinations, blood exams, radiography and renal sonography during 3 years. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent.
详细描述
Introduction:
The chronic strictures of the ureter are usually treated by double J stents. They allow the emptying of the kidney and avoid the deterioration of renal function. Unfortunately, double J stents have to be replaced every 6 month and are at the origin of irritative lower urinary tract symptoms and lumbar pain which corrupt the quality of life of the patients.
Ureteral stricture could also be treated with MEMOKATH 051. These new ureteral stents seem not to require iterative changes and also not to cause irritative symptoms and lumbar pain. MEMOKATH 051 could therefore allow to reduce the number of changes and to ameliorate the quality of life of the patients.
Main objective:
Main objective is to assess effectiveness and tolerance of the MEMOKATH ® 051 in the treatment of chronic strictures of the ureter.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-year-old or superior
- •Chronic stenosis of the ureter treated by placement of a ureteral endoprosthesis for more than six months;
- •No possibility for surgical or endoscopic treatment of the ureteral stricture
- •Free Consent, dated and signed by the patient
- •Affiliated Subject of a regime of French national health and pensions organization.
排除标准
- •Age under 18 year old
- •Pregnant or nursing Women
- •Patient having a life expectancy of less than 1 year
- •Patient having unique kidney
- •Patient having severe renal insufficiency (creatinin clearance under 30 ml/min)
- •Possible surgical or endoscopic treatment of ureteral stricture
- •Repeated urinary tract stones
- •Urothelial tumor of the bladder
- •Retro peritoneal fibrosis in the course of evolution
- •Complications of double J stents requiring more thanks a lot every 6 months
- •Against anaesthetic indication
- •Lithiasic inlay probe Double J with obstruction within 6 months
- •Persons put under maintenance of justice
- •Persons in inability to understand the sequence of try
研究组 & 干预措施
1
Memokath 051
干预措施: Insertion of Memokath 051 (Procedure)
结局指标
主要结局
Average durability of the stent MEMOKATH ® 051
时间窗: 3 years
次要结局
- Proportion of ureteral stent MEMOKATH ® 051 positioning failure(3 years)
- Average quality of life of the patients measured by auto-questionary(3 years)
- Proportion of patients to which the ureteral stent was definitely taken away(3 years)
- Expense of hospitalizations for replacement of the ureteral stent(3 years)
- Proportion of replacement of the ureteral stent(3 years)