Clinical trial NCT00790686: Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
Official title: Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ureteral Obstruction
Keywords: Ureteral obstruction
Urologic surgical procedure
Stents
Endoscopy
Urology
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2008-11-13
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Average durability of the stent MEMOKATH ® 051
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of ureteral stent MEMOKATH ® 051 positioning failure
timeFrame: 3 years
measure: Average quality of life of the patients measured by auto-questionary
timeFrame: 3 years
measure: Proportion of patients to which the ureteral stent was definitely taken away
timeFrame: 3 years
measure: Expense of hospitalizations for replacement of the ureteral stent
timeFrame: 3 years
measure: Proportion of replacement of the ureteral stent
timeFrame: 3 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Department of Urology, University Hospital, Bordeaux
city: Limoges
country: France
facility: Department of Urology, University Hospital, Limoges
city: Lyon
country: France
facility: Department of Urology, Hospices Civils de Lyon
city: Toulouse
country: France
facility: Department of Urology, University Hospital, Toulouse
Study officials:
affiliation: University Hospital, Bordeaux
name: Gregoire Robert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
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