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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00790686
First received: November 12, 2008
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Ureteral Obstruction
Procedure: Insertion of Memokath 051
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Average durability of the stent MEMOKATH ® 051 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of ureteral stent MEMOKATH ® 051 positioning failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Average quality of life of the patients measured by auto-questionary [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of patients to which the ureteral stent was definitely taken away [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Expense of hospitalizations for replacement of the ureteral stent [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Proportion of replacement of the ureteral stent [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: November 2008
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00790686

Locations
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
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Gregoire Robert, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
  More Information

Publications:

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00790686     History of Changes
Other Study ID Numbers: CHUBX2008/24
Study First Received: November 12, 2008
Last Updated: August 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Ureteral obstruction
Urologic surgical procedure
Stents
Endoscopy
Urology

Additional relevant MeSH terms:
Ureteral Obstruction
Constriction, Pathologic
Ureteral Diseases
Urologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 26, 2014