Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Resume: 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 examination, blood exams, radiography and renal sonography at 1 month, 3 month and every 6 month during a 3 years follow up period. If a problem of tolerance or effectiveness is diagnosed, the ureteral stent MEMOKATH 051 will be changed or replaced with a double J stent and an adverse event will be declared.

Official Title
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Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter

Conditions
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Ureteral Obstruction

Intervention / Treatment
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* Procedure: Insertion of Memokath 051


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Memokath 051 | Procedure: Insertion of Memokath 051<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average durability of the stent MEMOKATH ® 051 |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ureteral obstruction, Urologic surgical procedure, Stents, Endoscopy, Urology