Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter (TOTEME)
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ClinicalTrials.gov Identifier: NCT00790686 |
Recruitment Status
:
Completed
First Posted
: November 13, 2008
Last Update Posted
: August 21, 2014
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ureteral Obstruction | Procedure: Insertion of Memokath 051 | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 13 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter |
Study Start Date : | November 2008 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Memokath 051
|
Procedure: Insertion of Memokath 051
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.
|
- Average durability of the stent MEMOKATH ® 051 [ Time Frame: 3 years ]
- Proportion of ureteral stent MEMOKATH ® 051 positioning failure [ Time Frame: 3 years ]
- Average quality of life of the patients measured by auto-questionary [ Time Frame: 3 years ]
- Proportion of patients to which the ureteral stent was definitely taken away [ Time Frame: 3 years ]
- Expense of hospitalizations for replacement of the ureteral stent [ Time Frame: 3 years ]
- Proportion of replacement of the ureteral stent [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00790686
France | |
Department of Urology, University Hospital, Bordeaux | |
Bordeaux, France, 22076 | |
Department of Urology, University Hospital, Limoges | |
Limoges, France, 87042 | |
Department of Urology, Hospices Civils de Lyon | |
Lyon, France, 69437 | |
Department of Urology, University Hospital, Toulouse | |
Toulouse, France, 31059 |
Principal Investigator: | Gregoire Robert, MD | University Hospital, Bordeaux | |
Study Chair: | Antoine BENARD, MD | University Hospital, Bordeaux |
Publications:
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00790686 History of Changes |
Other Study ID Numbers: |
CHUBX2008/24 |
First Posted: | November 13, 2008 Key Record Dates |
Last Update Posted: | August 21, 2014 |
Last Verified: | August 2014 |
Keywords provided by University Hospital, Bordeaux:
Ureteral obstruction Urologic surgical procedure Stents Endoscopy Urology |
Additional relevant MeSH terms:
Ureteral Obstruction Ureteral Diseases Urologic Diseases |