Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790686
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : August 21, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE November 12, 2008
First Posted Date  ICMJE November 13, 2008
Last Update Posted Date August 21, 2014
Study Start Date  ICMJE November 2008
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
Average durability of the stent MEMOKATH ® 051 [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2013)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2008)
  • Proportion of ureteral stent MEMOKATH ® 051 positionning failure [ Time Frame: 3 years ]
  • Average quality of life of the patients measured by the ladder SF12 [ 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in Chronic Strictures of the Ureter
Official Title  ICMJE Study of Tolerance and Effectiveness of Ureteral Stents MEMOKATH ® 051 in the Treatment of Chronic Strictures of the Ureter
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ureteral Obstruction
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: 1
Memokath 051
Intervention: Procedure: Insertion of Memokath 051
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 30, 2010)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2008)
30
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00790686
Other Study ID Numbers  ICMJE CHUBX2008/24
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregoire Robert, MD University Hospital, Bordeaux
Study Chair: Antoine BENARD, MD University Hospital, Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP