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

University Hospital of Bordeaux

Status and phase: Completed; Phase 2

Conditions: Ureteral Obstruction

Treatments: Procedure: Insertion of Memokath 051

Study type: Interventional

Funder types: Other

Identifiers

NCT00790686

CHUBX2008/24

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

1

Experimental group

Description:

Memokath 051

Treatment:

Procedure: Insertion of Memokath 051